InflammationALIVENCT00667030
Aging, Lifestyle and Inflammation in Veterans Exercising
A study testing Weight loss and aerobic exercise training in people with Inflammation and Aging, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Over half of adults in this country are overweight. This increases risk for heart and blood pressure problems, cancer, stroke and arthritis. While it is difficult to lose large amounts of weight and keep it off, even small amounts of weight loss can improve health. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Aging, Metabolism
- What is being tested?
- Weight loss and aerobic exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to 13 Sep 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 20-40 kg/m2
- Waist 80-120cm (men), 70-110cm (women)
- Stable Medical Regimen > or = 30 days
- All women over the age of 50 must be postmenopausal for at least 1 year, have serum FSH >30 mIU/ml, and agree to remain off hormone replacement therapy for the duration of the study
Who cannot join
- Pregnancy or Nursing Mothers
- Cigarette Smoking
- Diabetes on Medication or Fasting Glucose >126 mg/dl
- Poorly controlled hypertension requiring >3 drugs or beta blockers
- Hyperlipidemia with TG>400mg/dl, LDL>190mg/dl or on Lipitor or Crestor
- Other medications affecting glucose, lipid or cytokine levels
Show all 21Show fewer
- Thyroid Disease
- Weight gain/loss >5kg in preceding 3 months
- Alcohol >3oz/day
- Caffeine >120 oz/day
- Chronic liver, renal or hematological disease
- Lung disease requiring oxygen
- Active cancer on radiation or chemotherapy treatment
- HIV (+) or other disease prone to malnutrition
- Sickle cell anemia
- Active psychosis or dementia
- Chronic untreated depression
- Hemiparetic Stroke
- Coronary Artery or cerebrovascular disease precluding exercise
- Implantable defibrillator
- Other medical condition precluding exercise testing or participation in exercise and weight loss programs, as per medical judgement of study team
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland; Baltimore VA Medical Center
Baltimore, Maryland, 21044
About this study
Over half of adults in this country are overweight. This increases risk for heart and blood pressure problems, cancer, stroke and arthritis. While it is difficult to lose large amounts of weight and keep it off, even small amounts of weight loss can improve health. Furthermore, fat is increasingly recognized as a source of substances that increase inflammation. It may be that some of the adverse consequences of being overweight are due to increased inflammation. We are asking you to volunteer for a research study in which you may lose a moderate amount of weight and increase your activity. It is important that you read and understand the information on this form.
The purposes of these studies are to determine the influence(s) of age and body composition on the production of inflammatory chemicals by fat (adipose tissue), the mechanisms controlling this, and if a weight loss and aerobic exercise intervention results in a decrease in inflammation.
Read the detailed description
Adipose tissue is increasingly recognized as more than an inert depot serving not only to accept and store excess energy in the form of triglycerides, but also to secrete hormones and adipokines that have substantial effects on lipid and glucose metabolism. Furthermore, there are depot differences in metabolic function, as well as adipokine content. However, the physiology both underlying and consequential to these observations remains unknown. This research is therefore designed to examine:
- the effects of aging and obesity on regional adipokine secretion and expression, 2) whether elevated adipokine levels in older obese people are due to increased macrophage infiltration into subcutaneous adipose tissue and/or related to total, subcutaneous or visceral abdominal fat (SAT or VAT) distribution, and 3) the relationship of adipokines to insulin resistance and the constituents of the metabolic syndrome.
Specifically, we aim to determine:
- if the expression and secretion of a) the inflammatory markers SAA, IL-6, TNF-a, MCP-1 is greater, and b) the anti-inflammatory hormone adiponectin is lower in SC abdominal and gluteal adipose tissue from older, compared to middle-aged and younger obese subjects across a narrow range of obesity and waist circumference;
- if these age-associated changes in adipokine production are a)due to the degree of macrophage infiltration of regional adipose tissue, and/or differences in a greater degree of visceral and/or differences in ABD fat distribution (SAT, VAT), and b) related to glucose and lipid metabolic profiles of the subjects; and
- the effects of a WL+AEX intervention on regional adipokine expression and secretion, circulating levels of CRP and the above adipokines, and glucose and lipid metabolism in a subset of obese sedentary individuals with greater than two components of the metabolic syndrome.
- Conditions
- Inflammation, Aging, Metabolism, Exercise
- Being tested
- Weight loss and aerobic exercise training
- Keywords
- Inflammation, Aging, Metabolism, Exercise
- Medical subject headings
- Inflammation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss and aerobic exercise trainingBehavioural
Weight loss and aerobic exercise training
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Modification | Experimental | Combined hypocaloric diet and aerobic exercise training Receives: Behavioral: Weight loss and aerobic exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional Adipokine Release
Measured: 6 month
Secondary outcomes (1)
Cardiovascular Fitness Body Composition Glucose Tolerance/Insulin Sensitivity
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2008 (estimated)
- Study startJul 2005
- Primary completion13 Sep 2018
- Study completion13 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Principal investigator, Jacob Blumenthal, University of Maryland, Baltimore
- Investigators
- Jacob B Blumenthal, MD, Principal investigator, Baltimore VA Medical Center, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00667030
- Sponsor's protocol ID
- HP-00041199
- Acronym
- ALIVE
- Status last verified
- Feb 2026
- First submitted
- 23 Apr 2008
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aging, Lifestyle and Inflammation in Veterans Exercising
- ClinicalTrials.gov ID
- NCT00667030
- Acronym / sponsor ID
- ALIVE / HP-00041199
- Conditions
- Inflammation, Aging, Metabolism, Exercise
- Keywords
- Inflammation, Aging, Metabolism, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Study start
- Jul 2005
- Primary completion
- 13 Sep 2018 (actual)
- Study completion
- 13 Sep 2018 (actual)
- First posted
- 25 Apr 2008 (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.
Over half of adults in this country are overweight. This increases risk for heart and blood pressure problems, cancer, stroke and arthritis. While it is difficult to lose large amounts of weight and keep it off, even small amounts of weight loss can improve health. Furthermore, fat is increasingly recognized as a source of substances that increase inflammation. It may be that some of the adverse consequences of being overweight are due to increased inflammation. We are asking you to volunteer for a research study in which you may lose a moderate amount of weight and increase your activity. It is important that you read and understand the information on this form.
The purposes of these studies are to determine the influence(s) of age and body composition on the production of inflammatory chemicals by fat (adipose tissue), the mechanisms controlling this, and if a weight loss and aerobic exercise intervention results in a decrease in inflammation.
Detailed description
Adipose tissue is increasingly recognized as more than an inert depot serving not only to accept and store excess energy in the form of triglycerides, but also to secrete hormones and adipokines that have substantial effects on lipid and glucose metabolism. Furthermore, there are depot differences in metabolic function, as well as adipokine content. However, the physiology both underlying and consequential to these observations remains unknown. This research is therefore designed to examine:
- the effects of aging and obesity on regional adipokine secretion and expression, 2) whether elevated adipokine levels in older obese people are due to increased macrophage infiltration into subcutaneous adipose tissue and/or related to total, subcutaneous or visceral abdominal fat (SAT or VAT) distribution, and 3) the relationship of adipokines to insulin resistance and the constituents of the metabolic syndrome.
Specifically, we aim to determine:
- if the expression and secretion of a) the inflammatory markers SAA, IL-6, TNF-a, MCP-1 is greater, and b) the anti-inflammatory hormone adiponectin is lower in SC abdominal and gluteal adipose tissue from older, compared to middle-aged and younger obese subjects across a narrow range of obesity and waist circumference;
- if these age-associated changes in adipokine production are a)due to the degree of macrophage infiltration of regional adipose tissue, and/or differences in a greater degree of visceral and/or differences in ABD fat distribution (SAT, VAT), and b) related to glucose and lipid metabolic profiles of the subjects; and
- the effects of a WL+AEX intervention on regional adipokine expression and secretion, circulating levels of CRP and the above adipokines, and glucose and lipid metabolism in a subset of obese sedentary individuals with greater than two components of the metabolic syndrome.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Modification | Experimental | Behavioral: Weight loss and aerobic exercise trainingCombined hypocaloric diet and aerobic exercise training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI 20-40 kg/m2
- Waist 80-120cm (men), 70-110cm (women)
- Stable Medical Regimen > or = 30 days
- All women over the age of 50 must be postmenopausal for at least 1 year, have serum FSH >30 mIU/ml, and agree to remain off hormone replacement therapy for the duration of the study
Key exclusion criteria (21 listed)
- Pregnancy or Nursing Mothers
- Cigarette Smoking
- Diabetes on Medication or Fasting Glucose >126 mg/dl
- Poorly controlled hypertension requiring >3 drugs or beta blockers
- Hyperlipidemia with TG>400mg/dl, LDL>190mg/dl or on Lipitor or Crestor
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 |
|---|---|---|
| Weight loss and aerobic exercise trainingWeight loss and aerobic exercise training | Behavioural | Lifestyle Modification |
Primary outcome
Regional Adipokine Release
Time frame: 6 month
1 secondary outcome
Cardiovascular Fitness Body Composition Glucose Tolerance/Insulin Sensitivity
Time frame: 6 month
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 20 Feb 2026.
- 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.
Jacob B Blumenthal, MD principal investigator
Baltimore VA Medical Center, University of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight loss and aerobic exercise training in people with Inflammation and Aging, run by University of Maryland, Baltimore 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 21 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 20 Feb 2026. 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?
Regional Adipokine Release (time frame: 6 month). 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 20 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.