Aging, Lifestyle and Inflammation in Veterans Exercising (ALIVE)

February 18, 2026 updated by: Jacob Blumenthal, University of Maryland, Baltimore

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

1) 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:

  1. 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;
  2. 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
  3. 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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21044
        • University of Maryland; Baltimore VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lifestyle Modification
Combined hypocaloric diet and aerobic exercise training
Behavioral: Weight loss and aerobic exercise training
Weight loss and aerobic exercise training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Regional Adipokine Release
Time Frame: 6 month
6 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular Fitness Body Composition Glucose Tolerance/Insulin Sensitivity
Time Frame: 6 month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Collaborators

US Department of Veterans Affairs

Investigators

  • Principal Investigator: Jacob B Blumenthal, MD, Baltimore VA Medical Center, University of Maryland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

September 13, 2018

Study Completion (Actual)

September 13, 2018

Study Registration Dates

First Submitted

April 23, 2008

First Submitted That Met QC Criteria

April 23, 2008

First Posted (Estimated)

April 25, 2008

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00041199

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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