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Aging, Lifestyle and Inflammation in Veterans Exercising
This study is currenly Recruiting patients.
Sponsored by:
University of Maryland
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.
Study Type: Intervention
| Condition | Intervention | Phase |
|
Inflammation Aging Metabolism Exercise |
Behavioral: Weight loss and aerobic exercise training | N/A |
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
Further Study Details:
Expected Total Enrollment:
Study Dates:July 2005 -
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- Min: 18 Years Max: N/A
Gender: Both
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
Inclusion Criteria:
FSH >30 mIU/ml, and agree to remain off hormone replacement therapy for the duration
of the study
Exclusion Criteria:
weight loss programs, as per medical judgement of study team
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier: NCT00667030
Maryland
University of Maryland; Baltimore VA Medical Center - Baltimore, Maryland 21044
Sandra Bozik, MS 410-605-7000 sbozik@grecc.umaryland.edu
More Information
Record Last Reviewed:November 2009
Last Updated:November 12, 2009
Record First Recieved:April 23, 2008
ClinicalTrials.gov Identifier:NCT00667030
Health Authority: United States Food and Drug Administration
Information obtained from ClinicalTrials.gov on September 02, 2010
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