Skip to main content
OpenTrials
Completed

NCT Number: NCT00753363

Exercise and Inflammation in the Elderly

Persistent low-grade inflammation and impaired fibrinolysis, are independent predictors of several chronic diseases highly prevalent in the older Veteran population including cardiovascular disease (CVD), stroke, and diabetes. Inflammation is likely to be a causative underlying mechanism of insulin resistance. Lifestyle changes such as weight loss and physical activity are advocated for the treatment of these chronic diseases and endpoints, and data are emerging which suggest that these treatments may be beneficial, in part, due to their anti-inflammatory effects. Identification of effective therapies that reduce chronic inflammation for Veterans is important given the widespread adverse health effects of a chronically elevated inflammatory state.

Completed

Looking for future studies?

Notify Me

Key information

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

About this study

This study will compare the effects of 6 month trial of aerobic exercise (AEX) vs. weight loss (WL) in older individuals on:

  • adipokine secretion and expression (tumor necrosis factor alpha, adiponectin);
  • adipose tissue and skeletal muscle inflammatory proximal receptor expression (adiponectin and tumor necrosis factor alpha expression) and signaling pathways; and
  • whether the changes in signal transduction are associated with changes in peripheral whole body insulin sensitivity by a hyperinsulinemic-euglycemic clamp.

The prevention and treatment of insulin resistance, the metabolic syndrome, and their CVD complications through exercise and weight loss could improve Veterans' health and reduce health care costs. Knowledge of their effectiveness has important implications for the cardiovascular health of Veterans given the widespread adverse health effects of chronic inflammation on vascular biology, skeletal muscle function and insulin action.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and Female
  • 45-80 yrs of age
  • Non-smoking for one year
  • Body mass index greater than 20 kg/m2 and less than 50 kg/m2
  • Menopause over 1 year

Exclusion criteria

  • Symptomatic heart disease, coronary artery disease, congestive heart failure, or uncontrolled hypertension (blood pressure over 180/100 mm Hg) unless medically stabilized
  • Currently being treated for active cancer
  • Type 1 diabetes; Insulin or oral agent treatment for diabetes, poorly controlled diabetes fasting blood glucose over 160 mg/dl
  • Allergic to lidocaine
  • Untreated dyslipidemia with National Cholesterol Adult Treatment Panel III 10 year cardiac risk score greater than 10%, or receiving triglyceride lowering meds
  • Other systemic disorders that are not medically treated and stable
  • Taking beta-blockers, oral steroids, warfarin or any other medications interfering with fat/muscle metabolism that may not be safely discontinued temporarily for specific procedures (ie for 72 hours prior)
  • Abnormal response to exercise test (ST segment depression greater than 2mm, chest pain, significant arrhythmias, extreme shortness of breath, cyanosis, exercising BP above 240/120mm Hg, or other contraindications to exercise) *requires follow up treatment w/ primary MD for continued participation in study
  • Abnormal liver function
  • Abnormal renal function
  • Chronic pulmonary disease
  • Anemia hematocrit below 35 mg/dl, platelets below 100,000/cm3
  • Mini-mental state exam below 24, dementia or unstable clinical depression by exam
  • Aerobically trained with maximal oxygen consumption greater than 2 standard deviations above age-adjusted mean
  • Exercise group only: History of cerebrovascular disease (by medical history) with symptoms limiting the ability to exercise

Treatment and study plan

Weight loss

Other

6 months of weight loss

Aerobic exercise training

Other

6 months of aerobic exercise training

Primary outcomes

  1. Insulin Sensitivity

    Time frame: Baseline and 6 month

    Insulin resistance is defined as a reduction in glucose utilization rate elicited by a given insulin concentration. Glucose utilization is measured during a three hour hyperinsulinemic-euglycemic clamp and is presented as a measure of insulin sensitivity. This is one of the most sophisticated methods to measure insulin sensitivity.

Secondary outcomes

  1. Body Weight

    Time frame: Baseline and 6 month

  2. Fitness

    Time frame: Baseline and 6 month

    Maximal oxygen consumption (VO2max) on a treadmill

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Johns Hopkins University
  • University of Maryland

Registry information

Official study title

Exercise, Inflammation and Pro-thrombotic Modulators in the Elderly

Acronym: IRIS

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Sep 16, 2008
Registry last updated
Jun 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.