Aging, Lifestyle and Inflammation in Veterans Exercising (ALIVE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jacob Blumenthal, University of Maryland
ClinicalTrials.gov Identifier:
NCT00667030
First received: April 23, 2008
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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 Intervention
Inflammation
Aging
Metabolism
Exercise
Behavioral: Weight loss and aerobic exercise training

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Aging, Lifestyle and Inflammation in Veterans Exercising

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Regional Adipokine Release [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiovascular Fitness Body Composition Glucose Tolerance/Insulin Sensitivity [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2005
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle Modification
Combined hypocaloric diet and aerobic exercise training
Behavioral: Weight loss and aerobic exercise training
Weight loss and aerobic exercise training

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667030

Locations
United States, Maryland
University of Maryland; Baltimore VA Medical Center
Baltimore, Maryland, United States, 21044
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Jacob B Blumenthal, MD Baltimore VA Medical Center, University of Maryland
  More Information

No publications provided

Responsible Party: Jacob Blumenthal, GRECC Investigator, University of Maryland
ClinicalTrials.gov Identifier: NCT00667030     History of Changes
Other Study ID Numbers: HP-00041199
Study First Received: April 23, 2008
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Inflammation
Aging
Metabolism
Exercise

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014