Cardiovascular DiseaseNCT02770872
The Association of SAA With Apolipoprotein B Affects Cardiovascular Risk
An observational study of Cardiovascular Disease, run by Lisa Tannock at 1 site in United States.
Trial summary
Cardiovascular disease (CVD) is the leading cause of death in developed nations and a major health issue in Veterans. Despite a number of different treatments, cardiovascular disease remains a major health burden, thus further treatments are needed. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Observation of SAA on apoB containing lipoproteins
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 28 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will recruit male and female subjects eligible for medical care within the VA healthcare system
Who may be able to join
- Up to 80 U.S. veterans age 50-75 will be recruited in the following three groups:
- Obese (BMI 27-45 kg/m2), metabolically healthy, (25-30 subjects)
- Obese (BMI 27-45 kg/m2), metabolic syndrome, (25-30 subjects)
- Obese (BMI 27-45 kg/m2), diabetic, (25-30 subjects)
Who cannot join
- The use of:
- Statins (we will not exclude subjects on lipid lowering medications if they are willing to discontinue them for 1-2 weeks prior to participation)
- Fibrates
- Niacin
- Anti-inflammatory drugs including Thiazolidinediones, non-steroidal anti-inflammatories (NSAID), aspirin, steroids
- Estrogen replacement
Show all 16Show fewer
- Conditions such as:
- Acute illness
- Chronic inflammatory illness (such as psoriasis, rheumatoid arthritis, lupus, etc.)
- Infections
- Impaired renal function (eGFR < 60 ml/min)
- Hypo- or hyperthyroidism (subjects biochemically euthyroid on levothyroxine therapy are permitted)
- Gastrointestinal dysfunction
- Lifestyles including:
- Use of tobacco products
- Consumption of > 3 drinks /day
Trial locations and contacts
1 site in 1 country.
About this study
Cardiovascular disease (CVD) is the leading cause of death in developed nations and a major health issue in Veterans. Despite a number of different treatments, cardiovascular disease remains a major health burden, thus further treatments are needed. Individuals with obesity and/or diabetes are at particularly high risk for cardiovascular disease, and research suggests that elevated levels of serum amyloid A (SAA) may contribute to cardiovascular disease, particularly atherosclerosis. In preliminary studies in both mouse and human the investigators have identified that SAA appears to shift between lipid particles. SAA is mainly found on high density lipoprotein (HDL) particles; however, the investigators have found that in both mice and humans with obesity and/or diabetes SAA is found on low density lipoprotein (LDL) and very low density lipoprotein (VLDL) particles, and the investigators hypothesize that the presence of SAA on LDL or VLDL makes these particles more likely to cause cardiovascular disease. To determine what leads SAA to shift between lipid particles, SAA knockout mice will be injected with HDL containing SAA then blood collected at several time points over 24 hours, and the lipid particles will be isolated to measure SAA. In some experiments the investigators will compare different isoforms of SAA, different types of HDL particles, or induce expression of enzymes likely involved in shifting SAA between particles. To determine if the presence of SAA makes lipid particles bind vascular matrix more strongly, the investigators will collect carotid arteries and compare the extent of lipid particles bound to the vascular matrix in the vessel wall when the particles have or do not have SAA present. If this research confirms this hypothesis then the presence of SAA on LDL or VLDL may 1) be a new marker indicating humans at highest risk for cardiovascular disease and 2) be a new target of therapy to prevent cardiovascular disease.
Read the detailed description
Clinical burden of CVD: CVD is the leading cause of death in developed nations and the VA population is no exception. Despite decades of research, technical, and pharmacological advances, CVD remains a major public health problem. This is partly due to our impaired ability to identify subjects at greatest risk for CVD events and thus the best candidates for pharmacological risk reducing therapies, and partly due to incomplete use or efficacy of currently available therapies. Epidemiological studies have identified major risk factors for CVD including elevated LDL cholesterol, low HDL cholesterol, hypertension, smoking and diabetes. However, despite targeting individuals with these risk factors with aggressive pharmacological interventions, CVD remains a major public health problem. Furthermore, even in individuals with risk factors who are treated with pharmacological or lifestyle interventions the CVD event rates are higher than in those who never had the risk factors. Recent epidemiologic data evaluating the American Heart Association-identified cardiovascular health metrics reported that the prevalence of having CVD risk factors at ideal levels is < 2%10; implying that >98% of the population are candidates for risk reduction. Clearly, health systems cannot cope with pharmacological interventions for such enormous target populations. Thus, additional risk stratifying markers are needed to identify those at highest risk for events and thus at greatest likelihood of benefit. Several biomarkers, including the acute phase reactants C reactive protein (CRP) and serum amyloid A (SAA) have been studied for their role in predicting CVD events. Both CRP and SAA are chronically elevated in individuals with obesity, metabolic syndrome (MetS), diabetes, rheumatoid arthritis, lupus and other chronic inflammatory conditions associated with increased CVD rates, raising the question of whether these biomarkers merely reflect underlying risk or play a causative role in CVD. Although emerging evidence has cast doubt on the role of CRP as a causative factor the investigators and others recently demonstrated that SAA is directly atherogenic in animal models. Thus, in addition to its role as a biomarker for CVD, SAA may play a causal role in CVD.
SAA: SAA is a family of acute phase proteins synthesized primarily in the liver. In healthy individuals SAA concentrations are < 5 mg/L but during an acute phase response SAA can increase up to 1000 mg/L for a few days, then it rapidly returns to baseline levels. However, chronic inflammatory states such as obesity, MetS, diabetes, rheumatoid arthritis etc, are associated with persistently and significantly elevated SAA concentrations of 30-100 mg/L. Acute elevations in SAA are proposed to play a major role in response to injury and inflammation, participating in cholesterol delivery to injured tissues, recruitment of inflammatory cells, and induction of tissue repair cytokines. However, the chronic elevations of SAA now prevalent in modern society likely reflect a maladaptive response and numerous studies are now examining potential roles of SAA in disease pathology. Using murine models in which acute phase SAA is over-expressed, the investigators and others demonstrated direct increases in atherosclerosis development.
SAA and apolipoprotein B (apoB) containing lipoproteins: SAA is a lipid binding apolipoprotein and lipid-free SAA has not been found in vivo. The dogma is that SAA is exclusively an HDL associated lipoprotein; however, the investigators and others have reported SAA on apoB-containing lipoproteins in both mice and humans. Several studies have reported on a complex termed SAA-LDL associated with components of MetS, remnant like particle cholesterol, smoking status, lifestyle interventions, and statin treatment. These studies suggest that SAA-LDL is a risk factor for CVD. In new preliminary studies the investigators demonstrate that SAA has a differential lipoprotein association in diabetes, and in post-prandial lipoprotein metabolism, and the investigators demonstrate that the presence of SAA on apoB-lipoproteins augments their proteoglycan binding, a key step in atherosclerosis development. Thus, emerging evidence suggests that the presence of SAA on apoB-lipoproteins may be a novel CVD risk factor, play a causal role in atherosclerosis, and thus be a therapeutic target.
Post-prandial apoB-lipoprotein metabolism: The various lipoproteins are defined based on size and density criteria, as well as by their protein constituents. However, even within each lipoprotein class there is considerable heterogeneity, as the particles undergo continuous remodeling. Briefly, lipids consumed in the diet associate with apoB-48 to form chylomicrons, which are transported in intestinal lymphatics before entering the bloodstream. Various enzymes act on newly formed chylomicrons shifting lipids and proteins between chylomicrons and HDLs before the chylomicron remnants are taken up by the liver. The liver re-packages the lipids into VLDL particles containing apoB-100. The hydrolysis of VLDL results in smaller apoB-100 particles called VLDL remnants or intermediate density lipoproteins (IDLs). Collectively, these particles are termed triglyceride rich lipoproteins (TGRLs).
Ongoing remodeling of TGRLs by various lipases leads to the formation of LDL. LDL can be taken up by peripheral tissues, including the vasculature, or by the liver. The sub-endothelial retention of apoB-containing particles initiates atherosclerosis.
Post-prandial lipoproteins and CVD: Elevated levels of LDL cholesterol and low levels of HDL cholesterol are documented risk factors for CVD and contribute causally to atherogenesis. However, individuals with obesity, MetS and diabetes do not typically have elevated LDL cholesterol; their dyslipidemia is characterized by elevated triglycerides and low HDL cholesterol. The role of triglycerides as a CVD risk factor remains controversial; however, post-prandial triglycerides may be a more significant risk factor than fasting triglycerides. As humans spend most of their lives in the post-prandial state, there is ongoing interest in the role of post-prandial lipoprotein metabolism in CVD risk. However, most studies have relied on fasting lipoprotein samples; triglycerides are the lipoprotein component most affected by food consumption. The mechanisms accounting for the excess prevalence of CVD in MetS and diabetic subjects beyond that predicted by the traditional CVD risk factors remain unclear; however, insulin resistant states are characterized by increased intestinal apoB48 production, increased TGRL production and delayed lipoprotein clearance, which may contribute to CVD prevalence. Retention of apoB- containing lipoproteins in the vascular wall by the ionic interaction between apoB and proteoglycans, leads to the initiation of atherosclerosis. Lipolysis of VLDL more than doubles its ability to cross the endothelium and deposit lipids in the subendothelial space. TGRLs have proportionately more triglyceride than cholesterol: however, their size means that they can deposit 5-20 times more cholesterol per particle in the subendothelial space compared to an LDL particle. Increased TGRL production and delayed particle clearance increases the likelihood of particle retention and cholesterol deposition in the subendothelial space. The investigators have novel preliminary data demonstrating that the presence of SAA on apoB-containing lipoproteins increases their proteoglycan binding. The investigators propose that the increased presence of SAA on apoB-containing post-prandial lipoproteins in insulin resistant states increases the atherogenicity of these particles and could be a mechanism accounting for the increased CVD prevalence in insulin resistant states such as MetS and diabetes.
HDL metabolism: Like VLDL and LDL, HDL comprises a range of particles; however, HDL does not contain apoB, instead containing apoA-I. HDL is often separated into two major classes by size and density: the large HDL2 and the smaller HDL3. As discussed above, HDL undergoes continuous lipid interchange with various apoB-containing lipoprotein particles. A change in lipoprotein structure or composition by various enzymes is termed remodeling. HDL is typically thought to be an atheroprotective lipoprotein due to its ability to transport cholesterol away from the periphery back to the liver. In addition, HDL has a number of other beneficial properties including anti-inflammatory and anti-oxidative functions. In insulin resistant states HDL levels tend to be low, and some studies suggest its beneficial properties are reduced. Remodeling of lipoproteins affects their functionality and half-life; for example, the remodeling of HDL by CETP (which transfers triglycerides from TGRL to HDL and cholesterol ester from HDL to TGRL) predisposes HDL to enhanced catabolism and is thought to contribute to the lower levels of HDL seen in insulin resistant states. Although the paradigm is that SAA is a HDL associated lipoprotein, in preliminary studies the investigators have found SAA on apoB particles in insulin resistant persons in the post-prandial period. However, it is not clear how SAA associates with either HDL or apoB-lipoprotein particles.
SAA lipoprotein association: In the setting of an acute phase response SAA levels can increase up to 1000-fold; however, even at these highly elevated levels SAA remains exclusively found on HDL particles. Thus, there is no evidence of a "maximum capacity" of HDL for SAA. How SAA associates with either HDL or apoB-lipoprotein particles is not fully understood. SAA is thought to be produced by the liver in a lipid-free form and bind lipoproteins extracellularly, or in plasma SAA has been shown to induce HDL biogenesis via ATP binding cassette 1 (ABCA1), which may be a major mechanism by which SAA associates with HDL. Murine studies using knockout mice demonstrated that in the absence of HDL, SAA was found on apoB-particles. However, the investigators and others have reported SAA on apoB particles despite the presence of HDL. In new preliminary studies the investigators found that the remodeling of HDL led to the liberation of both lipid-poor apoA-I and lipid-poor SAA, and that lipid-poor SAA associates with apoB particles. Thus, the remodeling of HDL, particularly in the post-prandial period, may lead to SAA shifting from HDL to apoB particles; alternately, SAA could associate with apoB particles during their hepatic secretion. Both HDL remodeling and hepatic apoB- particle secretion are increased in insulin resistant conditions.
Role of lipoprotein-proteoglycan interactions in atherogenesis: There are several hypotheses as to what triggers the initiation of atherosclerosis, with the "Response to Retention" hypothesis well supported by biomedical evidence. As outlined in this theory, early fatty streak lesions are initiated by deposition of atherogenic lipoproteins (LDLs and TGRLs) in the subendothelial matrix by their retention by extra cellular matrix proteoglycans. Studies show that lipoproteins migrate in and out of the subendothelial space, but once bound to proteoglycans these lipoproteins are retained in this region, become more susceptible to oxidation and other modifications, and are taken up by macrophages leading to the formation of foam cells. TGRLs may be even more atherogenic than LDLs as they don't need modification to be taken up by macrophages, and deliver 5-20 times more cholesterol than LDL on per particle basis. The investigators have demonstrated the presence of SAA on apoB-containing lipoprotein particles in mice, and recently confirmed this in humans. In preliminary studies the investigators demonstrate that the presence of SAA on apoB-lipoproteins enhances their proteoglycan binding. The investigators propose that the presence of SAA on apoB-containing lipoproteins enhances their retention increasing atherogenesis.
- Conditions
- Cardiovascular Disease
- Being tested
- Observation of SAA on apoB containing lipoproteins
- Keywords
- serum amyloid a, lipoprotein, insulin resistance, dyslipidemia
- Medical subject headings
- Cardiovascular Diseases, Insulin Resistance, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of SAA on apoB containing lipoproteinsOther
attempting to elicit the conditions by which SAA shifts from apo-A1 containing lipoproteins to apoB containing lipoproteins
| Study group | Role | What they receive |
|---|---|---|
| Obese, normal | Approximately 25 subjects aged 50-75 with BMI's between 27-45 kg/m2. Observation of SAA on apoB containing lipoproteins Receives: Other: Observation of SAA on apoB containing lipoproteins | |
| Obese, MetS | Approximately 25 subjects aged 50-75 with BMI's between 27-45 kg/m2, blood pressure above 135/80, HDL less than 40 mg/dl, triglycerides greater the 150 mg/dl and fasting blood glucose greater than 100 mg/dl but less than 126 mg/dl. Observation of SAA on apoB containing lipoproteins Receives: Other: Observation of SAA on apoB containing lipoproteins | |
| Obese, diabetic | Approximately 25 subjects aged 50-75 with BMI's between 27-45 kg/m2 and physician diagnosed diabetes mellitis. Observation of SAA on apoB containing lipoproteins Receives: Other: Observation of SAA on apoB containing lipoproteins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-prandial SAA content on apoB containing lipoproteins after consumption of a high fat shake
Subjects will arrive at the clinic fasted and have an IV line established. A baseline blood sample will be drawn at hour zero. The subject will then consume a high fat shake within a 15 minute window. Blood samples will then be drawn every hour for eight hours to determine the time course of SAA shifting from HDL to apoB containing lipoproteins.
Measured: Baseline and once every hour for 8 hours. Study completed in a single day
Degree of insulin resistance
Subjects will arrive at the clinic fasted. The subject will have IV sites established in both arms and two baseline blood samples will be drawn (-30 and -10 minute). At time zero, a bolus of glucose will be injected followed by blood sample collection. Blood will be collected at the following time points in minutes; 0, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 19. At time 20 minutes, the subject will receive an IV bolus of insulin and frequent blood sampling will continue at the following time points in minutes; 20, 22, 23, 24, 25, 27, 30, 40, 50, 70, 90, 100, 120, 140 ,160, 180, 210, 240. A total of 32 blood samples will be collected over the course of 4.5 hours.
Measured: 4.5 hour study completed in a single day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startFeb 2014
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lisa Tannock
- Sponsor type
- University, hospital or other
- Collaborators
- VA Office of Research and Development
- Responsible party
- Sponsor-investigator, Lisa Tannock, University of Kentucky
- Investigators
- Lisa R Tannock, MD, Principal investigator, VA Medical System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770872
- Sponsor's protocol ID
- TAN-14-002-HAF
- Status last verified
- Mar 2018
- First submitted
- 11 May 2015
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Williams KJ, Tabas I. The response-to-retention hypothesis of early atherogenesis. Arterioscler Thromb Vasc Biol. 1995 May;15(5):551-61. doi: 10.1161/01.atv.15.5.551. No abstract available.
PubMed 7749869Dong Z, Wu T, Qin W, An C, Wang Z, Zhang M, Zhang Y, Zhang C, An F. Serum amyloid A directly accelerates the progression of atherosclerosis in apolipoprotein E-deficient mice. Mol Med. 2011;17(11-12):1357-64. doi: 10.2119/molmed.2011.00186. Epub 2011 Sep 21.
PubMed 21953420Yang Q, Cogswell ME, Flanders WD, Hong Y, Zhang Z, Loustalot F, Gillespie C, Merritt R, Hu FB. Trends in cardiovascular health metrics and associations with all-cause and CVD mortality among US adults. JAMA. 2012 Mar 28;307(12):1273-83. doi: 10.1001/jama.2012.339. Epub 2012 Mar 16.
PubMed 22427615Genest J. C-reactive protein: risk factor, biomarker and/or therapeutic target? Can J Cardiol. 2010 Mar;26 Suppl A:41A-44A. doi: 10.1016/s0828-282x(10)71061-8.
PubMed 20386760Kisilevsky R, Manley PN. Acute-phase serum amyloid A: perspectives on its physiological and pathological roles. Amyloid. 2012 Mar;19(1):5-14. doi: 10.3109/13506129.2011.654294. Epub 2012 Feb 10.
PubMed 22320226Kotani K, Satoh N, Kato Y, Araki R, Koyama K, Okajima T, Tanabe M, Oishi M, Yamakage H, Yamada K, Hattori M, Shimatsu A; Japan Obesity and Metabolic Syndrome Study Group. A novel oxidized low-density lipoprotein marker, serum amyloid A-LDL, is associated with obesity and the metabolic syndrome. Atherosclerosis. 2009 Jun;204(2):526-31. doi: 10.1016/j.atherosclerosis.2008.09.017. Epub 2008 Sep 27.
PubMed 19007930Kotani K, Asahara-Satoh N, Kato Y, Araki R, Himeno A, Yamakage H, Koyama K, Tanabe M, Oishi M, Okajima T, Shimatsu A; Japan Obesity and Metabolic Syndrome Study (JOMS) Group. Remnant-like particle cholesterol and serum amyloid A-low-density lipoprotein levels in obese subjects with metabolic syndrome. J Clin Lipidol. 2011 Sep-Oct;5(5):395-400. doi: 10.1016/j.jacl.2011.08.001. Epub 2011 Aug 12.
PubMed 21981841Kotani K, Satoh-Asahara N, Kato Y, Araki R, Himeno A, Yamakage H, Koyama K, Tanabe M, Oishi M, Okajima T, Shimatsu A; Japan Obesity and Metabolic Syndrome Study Group. Serum amyloid A low-density lipoprotein levels and smoking status in obese Japanese patients. J Int Med Res. 2011;39(5):1917-22. doi: 10.1177/147323001103900536.
PubMed 22117994Kotani K, Koibuchi H, Yamada T, Taniguchi N. The effects of lifestyle modification on a new oxidized low-density lipoprotein marker, serum amyloid A-LDL, in subjects with primary lipid disorder. Clin Chim Acta. 2009 Nov;409(1-2):67-9. doi: 10.1016/j.cca.2009.08.019. Epub 2009 Aug 29.
PubMed 19723514Kotani K, Yamada T, Miyamoto M, Ishibashi S, Taniguchi N, Gugliucci A. Influence of atorvastatin on serum amyloid A-low density lipoprotein complex in hypercholesterolemic patients. Pharmacol Rep. 2012;64(1):212-6. doi: 10.1016/s1734-1140(12)70748-x.
PubMed 22580538Bansal S, Buring JE, Rifai N, Mora S, Sacks FM, Ridker PM. Fasting compared with nonfasting triglycerides and risk of cardiovascular events in women. JAMA. 2007 Jul 18;298(3):309-16. doi: 10.1001/jama.298.3.309.
PubMed 17635891Lindman AS, Veierod MB, Tverdal A, Pedersen JI, Selmer R. Nonfasting triglycerides and risk of cardiovascular death in men and women from the Norwegian Counties Study. Eur J Epidemiol. 2010 Nov;25(11):789-98. doi: 10.1007/s10654-010-9501-1. Epub 2010 Oct 2.
PubMed 20890636Nordestgaard BG, Benn M, Schnohr P, Tybjaerg-Hansen A. Nonfasting triglycerides and risk of myocardial infarction, ischemic heart disease, and death in men and women. JAMA. 2007 Jul 18;298(3):299-308. doi: 10.1001/jama.298.3.299.
PubMed 17635890Pang J, Chan DC, Barrett PH, Watts GF. Postprandial dyslipidaemia and diabetes: mechanistic and therapeutic aspects. Curr Opin Lipidol. 2012 Aug;23(4):303-9. doi: 10.1097/MOL.0b013e328354c790.
PubMed 22595742Rutledge JC, Mullick AE, Gardner G, Goldberg IJ. Direct visualization of lipid deposition and reverse lipid transport in a perfused artery : roles of VLDL and HDL. Circ Res. 2000 Apr 14;86(7):768-73. doi: 10.1161/01.res.86.7.768.
PubMed 10764410
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of SAA With Apolipoprotein B Affects Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT02770872
- Acronym / sponsor ID
- TAN-14-002-HAF
- Conditions
- Cardiovascular Disease
- Keywords
- serum amyloid a, lipoprotein, insulin resistance, dyslipidemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Lisa TannockUniversity, hospital or other
- Collaborators
- VA Office of Research and Development
- Study start
- Feb 2014
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 12 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiovascular disease (CVD) is the leading cause of death in developed nations and a major health issue in Veterans. Despite a number of different treatments, cardiovascular disease remains a major health burden, thus further treatments are needed. Individuals with obesity and/or diabetes are at particularly high risk for cardiovascular disease, and research suggests that elevated levels of serum amyloid A (SAA) may contribute to cardiovascular disease, particularly atherosclerosis. In preliminary studies in both mouse and human the investigators have identified that SAA appears to shift between lipid particles. SAA is mainly found on high density lipoprotein (HDL) particles; however, the investigators have found that in both mice and humans with obesity and/or diabetes SAA is found on low density lipoprotein (LDL) and very low density lipoprotein (VLDL) particles, and the investigators hypothesize that the presence of SAA on LDL or VLDL makes these particles more likely to cause cardiovascular disease. To determine what leads SAA to shift between lipid particles, SAA knockout mice will be injected with HDL containing SAA then blood collected at several time points over 24 hours, and the lipid particles will be isolated to measure SAA. In some experiments the investigators will compare different isoforms of SAA, different types of HDL particles, or induce expression of enzymes likely involved in shifting SAA between particles. To determine if the presence of SAA makes lipid particles bind vascular matrix more strongly, the investigators will collect carotid arteries and compare the extent of lipid particles bound to the vascular matrix in the vessel wall when the particles have or do not have SAA present. If this research confirms this hypothesis then the presence of SAA on LDL or VLDL may 1) be a new marker indicating humans at highest risk for cardiovascular disease and 2) be a new target of therapy to prevent cardiovascular disease.
Detailed description
Clinical burden of CVD: CVD is the leading cause of death in developed nations and the VA population is no exception. Despite decades of research, technical, and pharmacological advances, CVD remains a major public health problem. This is partly due to our impaired ability to identify subjects at greatest risk for CVD events and thus the best candidates for pharmacological risk reducing therapies, and partly due to incomplete use or efficacy of currently available therapies. Epidemiological studies have identified major risk factors for CVD including elevated LDL cholesterol, low HDL cholesterol, hypertension, smoking and diabetes. However, despite targeting individuals with these risk factors with aggressive pharmacological interventions, CVD remains a major public health problem. Furthermore, even in individuals with risk factors who are treated with pharmacological or lifestyle interventions the CVD event rates are higher than in those who never had the risk factors. Recent epidemiologic data evaluating the American Heart Association-identified cardiovascular health metrics reported that the prevalence of having CVD risk factors at ideal levels is < 2%10; implying that >98% of the population are candidates for risk reduction. Clearly, health systems cannot cope with pharmacological interventions for such enormous target populations. Thus, additional risk stratifying markers are needed to identify those at highest risk for events and thus at greatest likelihood of benefit. Several biomarkers, including the acute phase reactants C reactive protein (CRP) and serum amyloid A (SAA) have been studied for their role in predicting CVD events. Both CRP and SAA are chronically elevated in individuals with obesity, metabolic syndrome (MetS), diabetes, rheumatoid arthritis, lupus and other chronic inflammatory conditions associated with increased CVD rates, raising the question of whether these biomarkers merely reflect underlying risk or play a causative role in CVD. Although emerging evidence has cast doubt on the role of CRP as a causative factor the investigators and others recently demonstrated that SAA is directly atherogenic in animal models. Thus, in addition to its role as a biomarker for CVD, SAA may play a causal role in CVD.
SAA: SAA is a family of acute phase proteins synthesized primarily in the liver. In healthy individuals SAA concentrations are < 5 mg/L but during an acute phase response SAA can increase up to 1000 mg/L for a few days, then it rapidly returns to baseline levels. However, chronic inflammatory states such as obesity, MetS, diabetes, rheumatoid arthritis etc, are associated with persistently and significantly elevated SAA concentrations of 30-100 mg/L. Acute elevations in SAA are proposed to play a major role in response to injury and inflammation, participating in cholesterol delivery to injured tissues, recruitment of inflammatory cells, and induction of tissue repair cytokines. However, the chronic elevations of SAA now prevalent in modern society likely reflect a maladaptive response and numerous studies are now examining potential roles of SAA in disease pathology. Using murine models in which acute phase SAA is over-expressed, the investigators and others demonstrated direct increases in atherosclerosis development.
SAA and apolipoprotein B (apoB) containing lipoproteins: SAA is a lipid binding apolipoprotein and lipid-free SAA has not been found in vivo. The dogma is that SAA is exclusively an HDL associated lipoprotein; however, the investigators and others have reported SAA on apoB-containing lipoproteins in both mice and humans. Several studies have reported on a complex termed SAA-LDL associated with components of MetS, remnant like particle cholesterol, smoking status, lifestyle interventions, and statin treatment. These studies suggest that SAA-LDL is a risk factor for CVD. In new preliminary studies the investigators demonstrate that SAA has a differential lipoprotein association in diabetes, and in post-prandial lipoprotein metabolism, and the investigators demonstrate that the presence of SAA on apoB-lipoproteins augments their proteoglycan binding, a key step in atherosclerosis development. Thus, emerging evidence suggests that the presence of SAA on apoB-lipoproteins may be a novel CVD risk factor, play a causal role in atherosclerosis, and thus be a therapeutic target.
Post-prandial apoB-lipoprotein metabolism: The various lipoproteins are defined based on size and density criteria, as well as by their protein constituents. However, even within each lipoprotein class there is considerable heterogeneity, as the particles undergo continuous remodeling. Briefly, lipids consumed in the diet associate with apoB-48 to form chylomicrons, which are transported in intestinal lymphatics before entering the bloodstream. Various enzymes act on newly formed chylomicrons shifting lipids and proteins between chylomicrons and HDLs before the chylomicron remnants are taken up by the liver. The liver re-packages the lipids into VLDL particles containing apoB-100. The hydrolysis of VLDL results in smaller apoB-100 particles called VLDL remnants or intermediate density lipoproteins (IDLs). Collectively, these particles are termed triglyceride rich lipoproteins (TGRLs).
Ongoing remodeling of TGRLs by various lipases leads to the formation of LDL. LDL can be taken up by peripheral tissues, including the vasculature, or by the liver. The sub-endothelial retention of apoB-containing particles initiates atherosclerosis.
Post-prandial lipoproteins and CVD: Elevated levels of LDL cholesterol and low levels of HDL cholesterol are documented risk factors for CVD and contribute causally to atherogenesis. However, individuals with obesity, MetS and diabetes do not typically have elevated LDL cholesterol; their dyslipidemia is characterized by elevated triglycerides and low HDL cholesterol. The role of triglycerides as a CVD risk factor remains controversial; however, post-prandial triglycerides may be a more significant risk factor than fasting triglycerides. As humans spend most of their lives in the post-prandial state, there is ongoing interest in the role of post-prandial lipoprotein metabolism in CVD risk. However, most studies have relied on fasting lipoprotein samples; triglycerides are the lipoprotein component most affected by food consumption. The mechanisms accounting for the excess prevalence of CVD in MetS and diabetic subjects beyond that predicted by the traditional CVD risk factors remain unclear; however, insulin resistant states are characterized by increased intestinal apoB48 production, increased TGRL production and delayed lipoprotein clearance, which may contribute to CVD prevalence. Retention of apoB- containing lipoproteins in the vascular wall by the ionic interaction between apoB and proteoglycans, leads to the initiation of atherosclerosis. Lipolysis of VLDL more than doubles its ability to cross the endothelium and deposit lipids in the subendothelial space. TGRLs have proportionately more triglyceride than cholesterol: however, their size means that they can deposit 5-20 times more cholesterol per particle in the subendothelial space compared to an LDL particle. Increased TGRL production and delayed particle clearance increases the likelihood of particle retention and cholesterol deposition in the subendothelial space. The investigators have novel preliminary data demonstrating that the presence of SAA on apoB-containing lipoproteins increases their proteoglycan binding. The investigators propose that the increased presence of SAA on apoB-containing post-prandial lipoproteins in insulin resistant states increases the atherogenicity of these particles and could be a mechanism accounting for the increased CVD prevalence in insulin resistant states such as MetS and diabetes.
HDL metabolism: Like VLDL and LDL, HDL comprises a range of particles; however, HDL does not contain apoB, instead containing apoA-I. HDL is often separated into two major classes by size and density: the large HDL2 and the smaller HDL3. As discussed above, HDL undergoes continuous lipid interchange with various apoB-containing lipoprotein particles. A change in lipoprotein structure or composition by various enzymes is termed remodeling. HDL is typically thought to be an atheroprotective lipoprotein due to its ability to transport cholesterol away from the periphery back to the liver. In addition, HDL has a number of other beneficial properties including anti-inflammatory and anti-oxidative functions. In insulin resistant states HDL levels tend to be low, and some studies suggest its beneficial properties are reduced. Remodeling of lipoproteins affects their functionality and half-life; for example, the remodeling of HDL by CETP (which transfers triglycerides from TGRL to HDL and cholesterol ester from HDL to TGRL) predisposes HDL to enhanced catabolism and is thought to contribute to the lower levels of HDL seen in insulin resistant states. Although the paradigm is that SAA is a HDL associated lipoprotein, in preliminary studies the investigators have found SAA on apoB particles in insulin resistant persons in the post-prandial period. However, it is not clear how SAA associates with either HDL or apoB-lipoprotein particles.
SAA lipoprotein association: In the setting of an acute phase response SAA levels can increase up to 1000-fold; however, even at these highly elevated levels SAA remains exclusively found on HDL particles. Thus, there is no evidence of a "maximum capacity" of HDL for SAA. How SAA associates with either HDL or apoB-lipoprotein particles is not fully understood. SAA is thought to be produced by the liver in a lipid-free form and bind lipoproteins extracellularly, or in plasma SAA has been shown to induce HDL biogenesis via ATP binding cassette 1 (ABCA1), which may be a major mechanism by which SAA associates with HDL. Murine studies using knockout mice demonstrated that in the absence of HDL, SAA was found on apoB-particles. However, the investigators and others have reported SAA on apoB particles despite the presence of HDL. In new preliminary studies the investigators found that the remodeling of HDL led to the liberation of both lipid-poor apoA-I and lipid-poor SAA, and that lipid-poor SAA associates with apoB particles. Thus, the remodeling of HDL, particularly in the post-prandial period, may lead to SAA shifting from HDL to apoB particles; alternately, SAA could associate with apoB particles during their hepatic secretion. Both HDL remodeling and hepatic apoB- particle secretion are increased in insulin resistant conditions.
Role of lipoprotein-proteoglycan interactions in atherogenesis: There are several hypotheses as to what triggers the initiation of atherosclerosis, with the "Response to Retention" hypothesis well supported by biomedical evidence. As outlined in this theory, early fatty streak lesions are initiated by deposition of atherogenic lipoproteins (LDLs and TGRLs) in the subendothelial matrix by their retention by extra cellular matrix proteoglycans. Studies show that lipoproteins migrate in and out of the subendothelial space, but once bound to proteoglycans these lipoproteins are retained in this region, become more susceptible to oxidation and other modifications, and are taken up by macrophages leading to the formation of foam cells. TGRLs may be even more atherogenic than LDLs as they don't need modification to be taken up by macrophages, and deliver 5-20 times more cholesterol than LDL on per particle basis. The investigators have demonstrated the presence of SAA on apoB-containing lipoprotein particles in mice, and recently confirmed this in humans. In preliminary studies the investigators demonstrate that the presence of SAA on apoB-lipoproteins enhances their proteoglycan binding. The investigators propose that the presence of SAA on apoB-containing lipoproteins enhances their retention increasing atherogenesis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Obese, normal | – | Other: Observation of SAA on apoB containing lipoproteinsApproximately 25 subjects aged 50-75 with BMI's between 27-45 kg/m2. Observation of SAA on apoB containing lipoproteins |
| Obese, MetS | – | Other: Observation of SAA on apoB containing lipoproteinsApproximately 25 subjects aged 50-75 with BMI's between 27-45 kg/m2, blood pressure above 135/80, HDL less than 40 mg/dl, triglycerides greater the 150 mg/dl and fasting blood glucose greater than 100 mg/dl but less than 126 mg/dl. Observation of SAA on apoB containing lipoproteins |
| Obese, diabetic | – | Other: Observation of SAA on apoB containing lipoproteinsApproximately 25 subjects aged 50-75 with BMI's between 27-45 kg/m2 and physician diagnosed diabetes mellitis. Observation of SAA on apoB containing lipoproteins |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will recruit male and female subjects eligible for medical care within the VA healthcare system
Key inclusion criteria (4 listed)
- Obese (BMI 27-45 kg/m2), metabolically healthy, (25-30 subjects)
- Obese (BMI 27-45 kg/m2), metabolic syndrome, (25-30 subjects)
- Obese (BMI 27-45 kg/m2), diabetic, (25-30 subjects)
Key exclusion criteria (16 listed)
- Statins (we will not exclude subjects on lipid lowering medications if they are willing to discontinue them for 1-2 weeks prior to participation)
- Fibrates
- Niacin
- Anti-inflammatory drugs including Thiazolidinediones, non-steroidal anti-inflammatories (NSAID), aspirin, steroids
- Estrogen replacement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation of SAA on apoB containing lipoproteinsattempting to elicit the conditions by which SAA shifts from apo-A1 containing lipoproteins to apoB containing lipoproteins | Other | Obese, MetS, Obese, diabetic, Obese, normal |
Primary outcome
Post-prandial SAA content on apoB containing lipoproteins after consumption of a high fat shake
Time frame: Baseline and once every hour for 8 hours. Study completed in a single day
Subjects will arrive at the clinic fasted and have an IV line established. A baseline blood sample will be drawn at hour zero. The subject will then consume a high fat shake within a 15 minute window. Blood samples will then be drawn every hour for eight hours to determine the time course of SAA shifting from HDL to apoB containing lipoproteins.
Degree of insulin resistance
Time frame: 4.5 hour study completed in a single day
Subjects will arrive at the clinic fasted. The subject will have IV sites established in both arms and two baseline blood samples will be drawn (-30 and -10 minute). At time zero, a bolus of glucose will be injected followed by blood sample collection. Blood will be collected at the following time points in minutes; 0, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 19. At time 20 minutes, the subject will receive an IV bolus of insulin and frequent blood sampling will continue at the following time points in minutes; 20, 22, 23, 24, 25, 27, 30, 40, 50, 70, 90, 100, 120, 140 ,160, 180, 210, 240. A total of 32 blood samples will be collected over the course of 4.5 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Background: PubMed 7749869Williams KJ, Tabas I. The response-to-retention hypothesis of early atherogenesis. Arterioscler Thromb Vasc Biol. 1995 May;15(5):551-61. doi: 10.1161/01.atv.15.5.551. No abstract available.
- Background: PubMed 21953420Dong Z, Wu T, Qin W, An C, Wang Z, Zhang M, Zhang Y, Zhang C, An F. Serum amyloid A directly accelerates the progression of atherosclerosis in apolipoprotein E-deficient mice. Mol Med. 2011;17(11-12):1357-64. doi: 10.2119/molmed.2011.00186. Epub 2011 Sep 21.
- Background: PubMed 22427615Yang Q, Cogswell ME, Flanders WD, Hong Y, Zhang Z, Loustalot F, Gillespie C, Merritt R, Hu FB. Trends in cardiovascular health metrics and associations with all-cause and CVD mortality among US adults. JAMA. 2012 Mar 28;307(12):1273-83. doi: 10.1001/jama.2012.339. Epub 2012 Mar 16.
- Background: PubMed 20386760Genest J. C-reactive protein: risk factor, biomarker and/or therapeutic target? Can J Cardiol. 2010 Mar;26 Suppl A:41A-44A. doi: 10.1016/s0828-282x(10)71061-8.
- Background: PubMed 22320226Kisilevsky R, Manley PN. Acute-phase serum amyloid A: perspectives on its physiological and pathological roles. Amyloid. 2012 Mar;19(1):5-14. doi: 10.3109/13506129.2011.654294. Epub 2012 Feb 10.
- Background: PubMed 19007930Kotani K, Satoh N, Kato Y, Araki R, Koyama K, Okajima T, Tanabe M, Oishi M, Yamakage H, Yamada K, Hattori M, Shimatsu A; Japan Obesity and Metabolic Syndrome Study Group. A novel oxidized low-density lipoprotein marker, serum amyloid A-LDL, is associated with obesity and the metabolic syndrome. Atherosclerosis. 2009 Jun;204(2):526-31. doi: 10.1016/j.atherosclerosis.2008.09.017. Epub 2008 Sep 27.
- Background: PubMed 21981841Kotani K, Asahara-Satoh N, Kato Y, Araki R, Himeno A, Yamakage H, Koyama K, Tanabe M, Oishi M, Okajima T, Shimatsu A; Japan Obesity and Metabolic Syndrome Study (JOMS) Group. Remnant-like particle cholesterol and serum amyloid A-low-density lipoprotein levels in obese subjects with metabolic syndrome. J Clin Lipidol. 2011 Sep-Oct;5(5):395-400. doi: 10.1016/j.jacl.2011.08.001. Epub 2011 Aug 12.
- Background: PubMed 22117994Kotani K, Satoh-Asahara N, Kato Y, Araki R, Himeno A, Yamakage H, Koyama K, Tanabe M, Oishi M, Okajima T, Shimatsu A; Japan Obesity and Metabolic Syndrome Study Group. Serum amyloid A low-density lipoprotein levels and smoking status in obese Japanese patients. J Int Med Res. 2011;39(5):1917-22. doi: 10.1177/147323001103900536.
- Background: PubMed 19723514Kotani K, Koibuchi H, Yamada T, Taniguchi N. The effects of lifestyle modification on a new oxidized low-density lipoprotein marker, serum amyloid A-LDL, in subjects with primary lipid disorder. Clin Chim Acta. 2009 Nov;409(1-2):67-9. doi: 10.1016/j.cca.2009.08.019. Epub 2009 Aug 29.
- Background: PubMed 22580538Kotani K, Yamada T, Miyamoto M, Ishibashi S, Taniguchi N, Gugliucci A. Influence of atorvastatin on serum amyloid A-low density lipoprotein complex in hypercholesterolemic patients. Pharmacol Rep. 2012;64(1):212-6. doi: 10.1016/s1734-1140(12)70748-x.
- Background: PubMed 17635891Bansal S, Buring JE, Rifai N, Mora S, Sacks FM, Ridker PM. Fasting compared with nonfasting triglycerides and risk of cardiovascular events in women. JAMA. 2007 Jul 18;298(3):309-16. doi: 10.1001/jama.298.3.309.
- Background: PubMed 20890636Lindman AS, Veierod MB, Tverdal A, Pedersen JI, Selmer R. Nonfasting triglycerides and risk of cardiovascular death in men and women from the Norwegian Counties Study. Eur J Epidemiol. 2010 Nov;25(11):789-98. doi: 10.1007/s10654-010-9501-1. Epub 2010 Oct 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa R Tannock, MD principal investigator
VA Medical System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by Lisa Tannock at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-prandial SAA content on apoB containing lipoproteins after consumption of a high fat shake (time frame: Baseline and once every hour for 8 hours. Study completed in a single day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02770872, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.