ObesitysCD163NCT01463449
"Can Soluble-CD163 Discriminate Between Healthy and Unhealthy Obese Individuals?"
An observational study of Obesity and Insulin Resistance, run by University of Aarhus at 2 sites in Denmark.
Trial summary
CD163 is a membrane bound receptor primary expressed in monocytes and macrophages. A soluble variant of CD163 (sCD163) is present in plasma and is elevated in pathological condition activating the monocyte-macrophage system. Recently sCD163 is associated with various inflammatory conditions, ex. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Obesity, Insulin Resistance, Type 2-diabetes
- What is being tested?
- gastric bypass
- Type of treatment
- Surgery or procedure
- How many people
- 31 participants
- Where
- 2 sitesDenmark
- Study dates
- Nov 2011to Aug 2014
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: The cohorts will be selected from the department of Endokrinology at Aarhus University Hospital.
Who may be able to join
- Male/Female
- Legally competent (Habil)
- Age 30-60
- Approved to gastric bypass, according to current criteria in Denmark
- Written consent
- Investigators verification of the suitability
Who cannot join
- Heart, liver or kidney disease
- Treatment with cortisol
- MR-contraindications
- Abuse/addiction
- Malignancy
- Weight more than 145 kg because of problems with DXA and MRI
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Endocrinology, Aarhus University Hospital
Aarhus, 8000
Department of Endocrinology, Aarhus University Hospital
Aarhus C, 8000
About this study
Official title: "Influence of Obesity, Weight Loss, and Diet on Low Grade Inflammation With Particular Focus on the Macrophage Marker, Soluble-CD163 - a New Predictor of Diabetes.Can s-CD163 Discriminate Between Healthy and Unhealthy Obese Individuals?"
CD163 is a membrane bound receptor primary expressed in monocytes and macrophages. A soluble variant of CD163 (sCD163) is present in plasma and is elevated in pathological condition activating the monocyte-macrophage system. Recently sCD163 is associated with various inflammatory conditions, ex. adipose tissue inflammation and very recently to be a rather strong predictor of the development of type 2-diabetes. Only a subset of obese individuals develops insulin resistance, type 2-diabetes and related diseases. These healthy obese subjects are characterized of less adipose tissue inflammation and less insulin resistance as compared to unhealthy obese individuals. Consequently it would be of great importance to develop markers that could discriminate between healthy and unhealthy obese subjects. Aim: To investigate whether macrophage CD163 is involved in adipose tissue inflammation in obesity and thereby to the metabolic complications of metabolic syndrome. To investigate how sCD163 is regulated by metabolic factors such as obesity, fat distribution, weight loss and diet. Methods: Intervention study. 45 morbidly obese subject approved to gastric by-pass. Blood samples, MR-spectroscopy, DXA, weight control and fat biopsy are taken before and 12 month after surgery. Correlations studies: to investigate the influence of diet and weight loss on CD163 and sCD163. Perspective: To study the role of macrophages infiltration and activation for adipose tissue inflammation and to determine whether the macrophage marker, s-CD163, together with other markers will be able better to identify obese individuals who are at increased risk for developing complications such as diabetes
Read the detailed description
It is recognized that low grade inflammation is a key player in the development of atherosclerosis and insulin resistance (Haslam, James 2005). Circulating levels of inflammatory markers such as high sensitive C-reactive protein (hsCRP) and interleukin (IL)-6 are found to be increased in subjects with cardiovascular disease (CVD) and type 2-diabetes (Dandona, Aljada \& Bandyopadhyay 2004). We and others have shown that obesity, and in particular abdominal obesity, is associated with persistent increased level of inflammatory markers (Bruun et al. 2007, Christiansen et al. 2010a) . Thus this low grade of inflammation may represent "the common soil" for the pathogenesis of atherosclerosis and insulin resistance and represent the link between these metabolic disturbances and obesity.
Besides its function as a storage organ, the adipose tissue (AT) exerts a complex role in the organism. In obesity the adipose tissue is infiltrated by an increased amount of macrophages, and particular these macrophages express and release a wide range of hormones and cytokines, collectively called adipokines, which biological functions are shown to include involvement in glucose metabolism, lipid metabolism, adipocyte differentiation, immunity, vasculature and neuron development and eating behavior (Trayhurn, Wood 2004).
Among the adipokines expressed in the AT are pro-inflammatory cytokines as TNFα, IL-6, pro-inflammatory chemokines as IL-8, MCP-1, MIP1α, thrombotic factors as plasminogen inhibitor 1 (PAI-1), and AT specific proteins as adiponectin and leptin.
Hypertrophied adipocytes, as seen in obese subjects and associated with insulin resistance are shown to display a distinct gene expression of inflammatory markers compared to small human adipocytes and it is shown that adipocyte size is an important determinant of adipokine secretion. Moreover an positive association between the grade of obesity and the expression of pro-inflammatory cytokines as TNFα, IL-6, IL-8, has been found whereas and an inverse association between adiponectin and obesity has been reported (Kern et al. 2003, Bruun et al. 2003).In accordance with these observations, we have found the AT expression of MCP-1 was up-regulated in obese subjects (Christiansen, Richelsen \& Bruun 2005) whereas the AT expression of adiponectin in obese subjects (mean BMI 40 kg/m2 ) was found down-regulated with 50% as compared to lean subjects (mean BMI 22 kg/m2) (Christiansen et al. 2010b).
Thus, adipose tissue inflammation resulting in dysfunction of the adipose tissue may be the important factor relating obesity to insulin resistance, metabolic syndrome, diabetes, and cardiovascular diseases.
CD163:
CD-163 is a membrane bound receptor primary expressed in monocytes and macrophages. CD163 was originally described as a hemoglobin scavenger receptor since it is involved in removing hemoglobin released from ruptured red blood cells (Moestrup, Moller 2004). A soluble variant of CD-163 (s-CD-163) is present in plasma and is elevated in pathological condition activating the monocyte-macrophage system.
Recently s-CD-163 is associated with various inflammatory conditions (Moestrup, Moller 2004), and very recently to be a rather strong predictor of the development of type 2 diabetes in a large Danish cohort (Moller et al. 2011). Thus, s-CD-163 may be a marker both related to inflammation as well as to metabolic conditions maybe linking low grade inflammation and metabolic abnormalities, and furthermore, may be a marker of the obese state with complications.
Only a subset of overweight and obese individuals develops insulin resistance, type 2 diabetes and related diseases (Stefan et al. 2008, Bluher 2010). These "healthy" obese subjects are characterized of less adipose tissue inflammation and less insulin resistance as compared to unhealthy obese individuals. Consequently it would be of great importance to develop markers or predictors that could discriminate between "healthy" and unhealthy obese subjects in order to made a better selection for more invasive treatment such as e.g. surgery, pharmacotherapy etc.
Research Plan:
- Is CD163 pathophysiologically involved in adipose tissue inflammation in obesity? Adipose tissue (AT) is taken from various regions in lean to very obese subjects - from either subcutaneous fat biopsies (lean subjects), surgery (obese subjects - BMI> 30), and from bariatric surgery (gastric bypass) in the very obese subjects (BMI > 40) - both subcutaneous and visceral AT are investigated in parallel in the very obese individuals. In the adipose tissue the amount of macrophages will be determined by both biochemical (e.g. CD68) and microscopically methods (immunohistochemistry). Moreover, the gene expression (PCR) and protein (Western blot) of CD163 will be detected in AT and related to the expression and protein of a number of other proinflammatory adipokines.
- Is s-CD163 a marker of adipose tissue inflammation and metabolic disturbances? Blood samples from the individuals in project 1 will also be obtained and s-CD163 measured (in house sandwich ELISA kit (Moller, Hald \& Moestrup 2002)). These values will be related to the amount of macrophages in AT and the expression of CD136 in AT. Moreover, the insulin sensitivity determined by the HOMA model will be performed, and s-CD163 related to the HOMA score.
- Is s-CD163 affected by weight loss, and dietary changes ( e.g. the effect of fructose (proinflammatory) and the effect of resveratrol (antiinflammatory)?
- Weight loss will be induced by bariatric surgery (bypass) in very obese subjects (BMI > 40). S-CD163 and changes in insulin sensitivity (HOMA) and other inflammatory markers (e.g. hsCRP, IL-6, TNF, MCP-1, adiponectin etc.) will be measured before and after 6 and 12 months after surgery. From power calculations it is planned to include 45 very obese subjects in this study - half of them with type 2 diabetes.
- We have performed dietary investigations with fructose (soft drinks taken for 6 months in 50 overweight and obese subjects) which induces ectopic fat accumulation in the liver determined by MR-spectroscopy and insulin resistance, and dietary intervention with resveratrol which reduces liver fat and has antiinflammatory effects. In frozen plasma samples from these studies s-CD163 will be measured in order to get insight in the dietary effect of fructose and resveratrol on this and related markers.
- Conditions
- Obesity, Insulin Resistance, Type 2-diabetes, Inflammation
- Being tested
- gastric bypass
- Keywords
- Obesity, Soluble-CD163, Macrophage, Inflammation
- Medical subject headings
- Obesity, Insulin Resistance, Diabetes Mellitus, Type 2, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastric bypassProcedure or surgery
Also called Soluble-CD163
Low grade inflammation in adipose tissue before and after gastric bypass
| Study group | Role | What they receive |
|---|---|---|
| Obese | Obese subjects half with type 2-diabetes. Before and after gastric bypass. Expected reduction in weight 25 %. We expect a reduction in low grade inflammation in adipose tissue after weight loss. Receives: Procedure: gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low grade inflammation in adipose tissue after weight loss induced by gastric bypass
sCD163 measured by enzyme-linked immunosorbent assay (ELISA). And CD163 gene expression measured by Real Time PCR (RT-PCR).
Measured: Primary endpoint after 12 months.
Secondary outcomes (1)
Quantity of fat in the liver
The quantity of fat in the liver at baseline and again 12 months after surgery. Assessed by MR spectroscopy.
Measured: 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2013
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S, The Danish Medical Research Council
- Responsible party
- Sponsor
- Investigators
- Bjørn Richelsen, Prof. Dr.Med, Study director, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463449
- Sponsor's protocol ID
- 17913
- Acronym
- sCD163
- Status last verified
- Aug 2014
- First submitted
- 26 Oct 2011
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Influence of Obesity, Weight Loss, and Diet on Low Grade Inflammation With Particular Focus on the Macrophage Marker, Soluble-CD163 - a New Predictor of Diabetes.Can s-CD163 Discriminate Between Healthy and Unhealthy Obese Individuals?"
- ClinicalTrials.gov ID
- NCT01463449
- Acronym / sponsor ID
- sCD163 / 17913
- Conditions
- Obesity, Insulin Resistance, Type 2-diabetes, Inflammation
- Keywords
- Obesity, Soluble-CD163, Macrophage, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S, The Danish Medical Research Council
- Study start
- Nov 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 1 Nov 2011 (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.
CD163 is a membrane bound receptor primary expressed in monocytes and macrophages. A soluble variant of CD163 (sCD163) is present in plasma and is elevated in pathological condition activating the monocyte-macrophage system. Recently sCD163 is associated with various inflammatory conditions, ex. adipose tissue inflammation and very recently to be a rather strong predictor of the development of type 2-diabetes. Only a subset of obese individuals develops insulin resistance, type 2-diabetes and related diseases. These healthy obese subjects are characterized of less adipose tissue inflammation and less insulin resistance as compared to unhealthy obese individuals. Consequently it would be of great importance to develop markers that could discriminate between healthy and unhealthy obese subjects. Aim: To investigate whether macrophage CD163 is involved in adipose tissue inflammation in obesity and thereby to the metabolic complications of metabolic syndrome. To investigate how sCD163 is regulated by metabolic factors such as obesity, fat distribution, weight loss and diet. Methods: Intervention study. 45 morbidly obese subject approved to gastric by-pass. Blood samples, MR-spectroscopy, DXA, weight control and fat biopsy are taken before and 12 month after surgery. Correlations studies: to investigate the influence of diet and weight loss on CD163 and sCD163. Perspective: To study the role of macrophages infiltration and activation for adipose tissue inflammation and to determine whether the macrophage marker, s-CD163, together with other markers will be able better to identify obese individuals who are at increased risk for developing complications such as diabetes
Detailed description
It is recognized that low grade inflammation is a key player in the development of atherosclerosis and insulin resistance (Haslam, James 2005). Circulating levels of inflammatory markers such as high sensitive C-reactive protein (hsCRP) and interleukin (IL)-6 are found to be increased in subjects with cardiovascular disease (CVD) and type 2-diabetes (Dandona, Aljada \& Bandyopadhyay 2004). We and others have shown that obesity, and in particular abdominal obesity, is associated with persistent increased level of inflammatory markers (Bruun et al. 2007, Christiansen et al. 2010a) . Thus this low grade of inflammation may represent "the common soil" for the pathogenesis of atherosclerosis and insulin resistance and represent the link between these metabolic disturbances and obesity.
Besides its function as a storage organ, the adipose tissue (AT) exerts a complex role in the organism. In obesity the adipose tissue is infiltrated by an increased amount of macrophages, and particular these macrophages express and release a wide range of hormones and cytokines, collectively called adipokines, which biological functions are shown to include involvement in glucose metabolism, lipid metabolism, adipocyte differentiation, immunity, vasculature and neuron development and eating behavior (Trayhurn, Wood 2004).
Among the adipokines expressed in the AT are pro-inflammatory cytokines as TNFα, IL-6, pro-inflammatory chemokines as IL-8, MCP-1, MIP1α, thrombotic factors as plasminogen inhibitor 1 (PAI-1), and AT specific proteins as adiponectin and leptin.
Hypertrophied adipocytes, as seen in obese subjects and associated with insulin resistance are shown to display a distinct gene expression of inflammatory markers compared to small human adipocytes and it is shown that adipocyte size is an important determinant of adipokine secretion. Moreover an positive association between the grade of obesity and the expression of pro-inflammatory cytokines as TNFα, IL-6, IL-8, has been found whereas and an inverse association between adiponectin and obesity has been reported (Kern et al. 2003, Bruun et al. 2003).In accordance with these observations, we have found the AT expression of MCP-1 was up-regulated in obese subjects (Christiansen, Richelsen \& Bruun 2005) whereas the AT expression of adiponectin in obese subjects (mean BMI 40 kg/m2 ) was found down-regulated with 50% as compared to lean subjects (mean BMI 22 kg/m2) (Christiansen et al. 2010b).
Thus, adipose tissue inflammation resulting in dysfunction of the adipose tissue may be the important factor relating obesity to insulin resistance, metabolic syndrome, diabetes, and cardiovascular diseases.
CD163:
CD-163 is a membrane bound receptor primary expressed in monocytes and macrophages. CD163 was originally described as a hemoglobin scavenger receptor since it is involved in removing hemoglobin released from ruptured red blood cells (Moestrup, Moller 2004). A soluble variant of CD-163 (s-CD-163) is present in plasma and is elevated in pathological condition activating the monocyte-macrophage system.
Recently s-CD-163 is associated with various inflammatory conditions (Moestrup, Moller 2004), and very recently to be a rather strong predictor of the development of type 2 diabetes in a large Danish cohort (Moller et al. 2011). Thus, s-CD-163 may be a marker both related to inflammation as well as to metabolic conditions maybe linking low grade inflammation and metabolic abnormalities, and furthermore, may be a marker of the obese state with complications.
Only a subset of overweight and obese individuals develops insulin resistance, type 2 diabetes and related diseases (Stefan et al. 2008, Bluher 2010). These "healthy" obese subjects are characterized of less adipose tissue inflammation and less insulin resistance as compared to unhealthy obese individuals. Consequently it would be of great importance to develop markers or predictors that could discriminate between "healthy" and unhealthy obese subjects in order to made a better selection for more invasive treatment such as e.g. surgery, pharmacotherapy etc.
Research Plan:
- Is CD163 pathophysiologically involved in adipose tissue inflammation in obesity? Adipose tissue (AT) is taken from various regions in lean to very obese subjects - from either subcutaneous fat biopsies (lean subjects), surgery (obese subjects - BMI> 30), and from bariatric surgery (gastric bypass) in the very obese subjects (BMI > 40) - both subcutaneous and visceral AT are investigated in parallel in the very obese individuals. In the adipose tissue the amount of macrophages will be determined by both biochemical (e.g. CD68) and microscopically methods (immunohistochemistry). Moreover, the gene expression (PCR) and protein (Western blot) of CD163 will be detected in AT and related to the expression and protein of a number of other proinflammatory adipokines.
- Is s-CD163 a marker of adipose tissue inflammation and metabolic disturbances? Blood samples from the individuals in project 1 will also be obtained and s-CD163 measured (in house sandwich ELISA kit (Moller, Hald \& Moestrup 2002)). These values will be related to the amount of macrophages in AT and the expression of CD136 in AT. Moreover, the insulin sensitivity determined by the HOMA model will be performed, and s-CD163 related to the HOMA score.
- Is s-CD163 affected by weight loss, and dietary changes ( e.g. the effect of fructose (proinflammatory) and the effect of resveratrol (antiinflammatory)?
- Weight loss will be induced by bariatric surgery (bypass) in very obese subjects (BMI > 40). S-CD163 and changes in insulin sensitivity (HOMA) and other inflammatory markers (e.g. hsCRP, IL-6, TNF, MCP-1, adiponectin etc.) will be measured before and after 6 and 12 months after surgery. From power calculations it is planned to include 45 very obese subjects in this study - half of them with type 2 diabetes.
- We have performed dietary investigations with fructose (soft drinks taken for 6 months in 50 overweight and obese subjects) which induces ectopic fat accumulation in the liver determined by MR-spectroscopy and insulin resistance, and dietary intervention with resveratrol which reduces liver fat and has antiinflammatory effects. In frozen plasma samples from these studies s-CD163 will be measured in order to get insight in the dietary effect of fructose and resveratrol on this and related markers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese | – | Procedure: gastric bypassObese subjects half with type 2-diabetes. Before and after gastric bypass. Expected reduction in weight 25 %. We expect a reduction in low grade inflammation in adipose tissue after weight loss. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The cohorts will be selected from the department of Endokrinology at Aarhus University Hospital.
Key inclusion criteria (6 listed)
- Male/Female
- Legally competent (Habil)
- Age 30-60
- Approved to gastric bypass, according to current criteria in Denmark
- Written consent
Key exclusion criteria (6 listed)
- Heart, liver or kidney disease
- Treatment with cortisol
- MR-contraindications
- Abuse/addiction
- Malignancy
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 |
|---|---|---|
| gastric bypassAlso: Soluble-CD163Low grade inflammation in adipose tissue before and after gastric bypass | Procedure or surgery | Obese |
Primary outcome
Low grade inflammation in adipose tissue after weight loss induced by gastric bypass
Time frame: Primary endpoint after 12 months.
sCD163 measured by enzyme-linked immunosorbent assay (ELISA). And CD163 gene expression measured by Real Time PCR (RT-PCR).
1 secondary outcome
Quantity of fat in the liver
Time frame: 12 months.
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 13 Aug 2014.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Bjørn Richelsen, Prof. Dr.Med study director
Aarhus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Insulin Resistance, run by University of Aarhus at 2 sites in Denmark.
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 6 inclusion and 6 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 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Low grade inflammation in adipose tissue after weight loss induced by gastric bypass (time frame: Primary endpoint after 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2014.