HypertensionNCT01517113
Age-Related Changes in Body Composition
An observational study of Hypertension and Atherosclerosis, run by National Institute on Aging (NIA) at 2 sites in United States.
Trial summary
Background: Advancing age is associated with greater risk of heart disease. High blood pressure and hardening of the arteries also have more complications with age. Studies suggest that age-related inflammation may affect fatty tissue in the body. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Atherosclerosis
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jan 2012to 13 Oct 2017
- 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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50-90 years
- Body mass index greater than or equal to 20 and less than or equal to 35
- Weight is less than 300 lbs
- In addition, for CAD participants (Group B):
- Catheterization-documented coronary artery disease, defined as greater than or equal to 70% stenosis in a major epicardial coronary artery, or greater than or equal to 50% stenosis of the left main coronary artery OR
- Prior myocardial infarction defined by ischemic symptoms associated with ECG changes and enzyme elevation.
- In addition, for CAD participants in whom arterial and hepatic vein inflammatory mediators will be obtained:
- Scheduled for clinically indicated right or left heart catheterization, no contraindication for the procedure, and consented to the research procedure.
Who cannot join
- Known inflammatory disease
- Known liver disease
- Abnormal liver function tests defined by enzyme rise to greater than three times the upper limit of normal.
- Contraindications to the performance of MRI scans
- Chronic use of anti-inflammatory agents other than low dose aspirin (81mg). Chronic use is defined here as the inability to stop taking their anti-inflammatory agent for at least one week before starting this study
- Pregnant or lactating
Show all 14Show fewer
- In addition, for BLSA participants:
- Known coronary artery disease by prior history, examination, or resting or stress electrocardiogram testing.
- In addition, for CAD participants undergoing arterial and hepatic vein inflammatory mediator sampling:
- Receiving therapy with heparin, a glycoprotein IIB/IIIA inhibitor, or bivalirudin
- History of atrial fibrillation
- Presence of an inferior vena cava filter
- Deep venous thrombosis
- Active infection.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins University
Baltimore, Maryland, 21205
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, 21224
About this study
Official title: Age-Associated Changes in Regional Adiposity and Novel Cardiovascular Risk Factors
Background:
- Advancing age is associated with greater risk of heart disease. High blood pressure and hardening of the arteries also have more complications with age. Studies suggest that age-related inflammation may affect fatty tissue in the body. If this fat develops in the muscles or around the heart, it may increase risks of heart disease. Researchers will study body composition in older adults to see if age-related changes in body fat are related to higher risks of heart disease.
Read more
Objectives:
- To study the relationship between fat deposits and aging, and greater risks of heart disease.
Eligibility:
- Participants in the Baltimore Longitudinal Study of Aging between 50 and 80 years of age.
- Individuals between 50 and 80 years of age who have been diagnosed with coronary artery disease.
Design:
- Participants will be screened with a physical exam and medical history.
- Participants will provide blood and urine samples. They will also have their height and weight measured. Waist circumference will also be taken.
- Participants will have a DEXA scan to study their muscles.
- Participants will have magnetic resonance imaging scans. These scans will study heart function and muscle and blood vessel health.
- Participants with coronary artery disease will have catheterization. Blood samples will be collected during the procedure....
Read the detailed description
Advancing age is associated with an increasing prevalence, incidence, and complications of cardiovascular diseases, particularly hypertension and atherosclerosis. The reasons why age is associated with increased susceptibility to cardiovascular diseases are not understood but recent literature suggests that systemic inflammation, by affecting endothelial function, vascular stiffening, diastolic dysfunction and insulin resistance may be an important contributing cause. Aging is also associated with substantial changes in body composition, primarily an increase in fat mass and a decline in lean body mass. Studies in animal models and in humans have shown that the adipose tissue is an important source of pro-inflammatory mediators and suggested that changes in body composition may be the primary cause of the pro-inflammatory state of aging. A number of gene expression studies in animal models show that genes of several pro-inflammatory cytokines are over-expressed with aging, especially in the adipose tissue. The overproduction of pro-inflammatory cytokines have important systemic effects, including (1) endothelial dysfunction, one of the earliest features of atherosclerosis; (2) vascular stiffening, the primary etiology for isolated systolic hypertension in the elderly; and (3) insulin resistance, the principal metabolic abnormality associated with cardiovascular risk. Fat infiltration in the liver also promotes chronic inflammation both directly and by inducing apoptosis of hepatocytes with consequent inflammatory response and deterioration of liver function.
Limited data exists suggesting that deposition of adipose tissue in specific districts but not in others is associated with high circulating levels of pro-inflammatory markers. For example, in humans central adiposity, including fat accumulation surrounding the heart, and fat infiltration in the muscle, opposed to subcutaneous adiposity seems to be particularly pro-inflammatory. However, this information comes from small studies, or studies limited to a very narrow age-range. In addition, the assessment of regional adiposity was mostly based on anthropometrics. Indeed, non-invasive methodology for the assessment of regional lipid deposition profiles has become available only recently.
We propose to complement the BLSA population with a group of individuals with established CAD because the inclusion of this group may help to determine whether, and if so the extent to which, the expected relationships between body adiposity, inflammation, endothelial dysfunction, arterial stiffness and insulin resistance are different in healthy individuals compared to age-matched individuals with clinically overt vascular disease.
As a side hypothesis, we will also verify whether changes in Testosterone with age are associated with changes in regional fat accumulation. To test this hypothesis we will measure total, free and biovailable Testosterone in all participants.
- Conditions
- Hypertension, Atherosclerosis
- Keywords
- Endothelial Dysfunction, Hepatic, Adiposity, Cytokines, Muscle Mass, Coronary Artery Disease, Aging, Inflammation
- Medical subject headings
- Hypertension, Atherosclerosis, Obesity, Coronary Artery Disease, Inflammation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study start2 Jan 2012
- Study completion13 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Luigi Ferrucci, M.D., Principal investigator, National Institute on Aging (NIA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517113
- Sponsor's protocol ID
- 120019
- Other IDs
- 12-AG-0019
- Status last verified
- 13 Oct 2017
- First submitted
- 24 Jan 2012
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
Singh T, Newman AB. Inflammatory markers in population studies of aging. Ageing Res Rev. 2011 Jul;10(3):319-29. doi: 10.1016/j.arr.2010.11.002. Epub 2010 Dec 8.
PubMed 21145432Ferrucci L, Corsi A, Lauretani F, Bandinelli S, Bartali B, Taub DD, Guralnik JM, Longo DL. The origins of age-related proinflammatory state. Blood. 2005 Mar 15;105(6):2294-9. doi: 10.1182/blood-2004-07-2599. Epub 2004 Nov 30.
PubMed 15572589Brooks GC, Blaha MJ, Blumenthal RS. Relation of C-reactive protein to abdominal adiposity. Am J Cardiol. 2010 Jul 1;106(1):56-61. doi: 10.1016/j.amjcard.2010.02.017. Epub 2010 May 13.
PubMed 20609648
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-Associated Changes in Regional Adiposity and Novel Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT01517113
- Acronym / sponsor ID
- 120019
- Conditions
- Hypertension, Atherosclerosis
- Keywords
- Endothelial Dysfunction, Hepatic, Adiposity, Cytokines, Muscle Mass, Coronary Artery Disease, Aging, Inflammation
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 24 participants (actual)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- 2 Jan 2012
- Study completion
- 13 Oct 2017
- First posted
- 25 Jan 2012 (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.
Background:
- Advancing age is associated with greater risk of heart disease. High blood pressure and hardening of the arteries also have more complications with age. Studies suggest that age-related inflammation may affect fatty tissue in the body. If this fat develops in the muscles or around the heart, it may increase risks of heart disease. Researchers will study body composition in older adults to see if age-related changes in body fat are related to higher risks of heart disease.
Objectives:
- To study the relationship between fat deposits and aging, and greater risks of heart disease.
Eligibility:
- Participants in the Baltimore Longitudinal Study of Aging between 50 and 80 years of age.
- Individuals between 50 and 80 years of age who have been diagnosed with coronary artery disease.
Design:
- Participants will be screened with a physical exam and medical history.
- Participants will provide blood and urine samples. They will also have their height and weight measured. Waist circumference will also be taken.
- Participants will have a DEXA scan to study their muscles.
- Participants will have magnetic resonance imaging scans. These scans will study heart function and muscle and blood vessel health.
- Participants with coronary artery disease will have catheterization. Blood samples will be collected during the procedure....
Detailed description
Advancing age is associated with an increasing prevalence, incidence, and complications of cardiovascular diseases, particularly hypertension and atherosclerosis. The reasons why age is associated with increased susceptibility to cardiovascular diseases are not understood but recent literature suggests that systemic inflammation, by affecting endothelial function, vascular stiffening, diastolic dysfunction and insulin resistance may be an important contributing cause. Aging is also associated with substantial changes in body composition, primarily an increase in fat mass and a decline in lean body mass. Studies in animal models and in humans have shown that the adipose tissue is an important source of pro-inflammatory mediators and suggested that changes in body composition may be the primary cause of the pro-inflammatory state of aging. A number of gene expression studies in animal models show that genes of several pro-inflammatory cytokines are over-expressed with aging, especially in the adipose tissue. The overproduction of pro-inflammatory cytokines have important systemic effects, including (1) endothelial dysfunction, one of the earliest features of atherosclerosis; (2) vascular stiffening, the primary etiology for isolated systolic hypertension in the elderly; and (3) insulin resistance, the principal metabolic abnormality associated with cardiovascular risk. Fat infiltration in the liver also promotes chronic inflammation both directly and by inducing apoptosis of hepatocytes with consequent inflammatory response and deterioration of liver function.
Limited data exists suggesting that deposition of adipose tissue in specific districts but not in others is associated with high circulating levels of pro-inflammatory markers. For example, in humans central adiposity, including fat accumulation surrounding the heart, and fat infiltration in the muscle, opposed to subcutaneous adiposity seems to be particularly pro-inflammatory. However, this information comes from small studies, or studies limited to a very narrow age-range. In addition, the assessment of regional adiposity was mostly based on anthropometrics. Indeed, non-invasive methodology for the assessment of regional lipid deposition profiles has become available only recently.
We propose to complement the BLSA population with a group of individuals with established CAD because the inclusion of this group may help to determine whether, and if so the extent to which, the expected relationships between body adiposity, inflammation, endothelial dysfunction, arterial stiffness and insulin resistance are different in healthy individuals compared to age-matched individuals with clinically overt vascular disease.
As a side hypothesis, we will also verify whether changes in Testosterone with age are associated with changes in regional fat accumulation. To test this hypothesis we will measure total, free and biovailable Testosterone in all participants.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 50-90 years
- Body mass index greater than or equal to 20 and less than or equal to 35
- Weight is less than 300 lbs
- Catheterization-documented coronary artery disease, defined as greater than or equal to 70% stenosis in a major epicardial coronary artery, or greater than or equal to 50% stenosis of the left main coronary artery OR
- Prior myocardial infarction defined by ischemic symptoms associated with ECG changes and enzyme elevation.
Key exclusion criteria (14 listed)
- Known inflammatory disease
- Known liver disease
- Abnormal liver function tests defined by enzyme rise to greater than three times the upper limit of normal.
- Contraindications to the performance of MRI scans
- Chronic use of anti-inflammatory agents other than low dose aspirin (81mg). Chronic use is defined here as the inability to stop taking their anti-inflammatory agent for at least one week before starting this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Background: PubMed 21145432Singh T, Newman AB. Inflammatory markers in population studies of aging. Ageing Res Rev. 2011 Jul;10(3):319-29. doi: 10.1016/j.arr.2010.11.002. Epub 2010 Dec 8.
- Background: PubMed 15572589Ferrucci L, Corsi A, Lauretani F, Bandinelli S, Bartali B, Taub DD, Guralnik JM, Longo DL. The origins of age-related proinflammatory state. Blood. 2005 Mar 15;105(6):2294-9. doi: 10.1182/blood-2004-07-2599. Epub 2004 Nov 30.
- Background: PubMed 20609648Brooks GC, Blaha MJ, Blumenthal RS. Relation of C-reactive protein to abdominal adiposity. Am J Cardiol. 2010 Jul 1;106(1):56-61. doi: 10.1016/j.amjcard.2010.02.017. Epub 2010 May 13.
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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.
Luigi Ferrucci, M.D. principal investigator
National Institute on Aging (NIA)
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 Hypertension and Atherosclerosis, run by National Institute on Aging (NIA) at 2 sites 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 8 inclusion and 14 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: stopped early, as of the sponsor's last update on 5 Apr 2018. 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 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 was stopped early. Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01517113, which also lists 3 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 5 Apr 2018.