Aging, Lifestyle and Inflammation in Veterans Exercising (ALIVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00667030
Recruitment Status : Active, not recruiting
First Posted : April 25, 2008
Last Update Posted : June 11, 2018
VA Office of Research and Development
Information provided by (Responsible Party):
Jacob Blumenthal, University of Maryland

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Inflammation Aging Metabolism Exercise Behavioral: Weight loss and aerobic exercise training Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Aging, Lifestyle and Inflammation in Veterans Exercising
Study Start Date : July 2005
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Regional Adipokine Release [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. Cardiovascular Fitness Body Composition Glucose Tolerance/Insulin Sensitivity [ Time Frame: 6 month ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00667030

United States, Maryland
University of Maryland; Baltimore VA Medical Center
Baltimore, Maryland, United States, 21044
Sponsors and Collaborators
University of Maryland
VA Office of Research and Development
Principal Investigator: Jacob B Blumenthal, MD Baltimore VA Medical Center, University of Maryland

Responsible Party: Jacob Blumenthal, GRECC Investigator, University of Maryland Identifier: NCT00667030     History of Changes
Other Study ID Numbers: HP-00041199
First Posted: April 25, 2008    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018

Keywords provided by Jacob Blumenthal, University of Maryland:

Additional relevant MeSH terms:
Pathologic Processes