Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Exercise and Inflammation in the Elderly (IRIS)

This study is ongoing, but not recruiting participants.
University of Maryland
Johns Hopkins University
Information provided by (Responsible Party):
Department of Veterans Affairs Identifier:
First received: September 12, 2008
Last updated: January 22, 2015
Last verified: January 2015

September 12, 2008
January 22, 2015
April 2007
November 2012   (final data collection date for primary outcome measure)
Insulin Sensitivity [ Time Frame: Baseline and 6 month ] [ Designated as safety issue: No ]
Insulin sensitivity is measured during a three hour hyperinsulinemic-euglycemic clamp.
Insulin Sensitivity [ Time Frame: Before and after the exercise training or weight loss intervention. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00753363 on Archive Site
  • Body Weight [ Time Frame: Baseline and 6 month ] [ Designated as safety issue: No ]
  • Fitness [ Time Frame: Baseline and 6 month ] [ Designated as safety issue: No ]
    Maximal oxygen consumption (VO2max) on a treadmill
  • Adipose tissue and skeletal muscle inflammation [ Time Frame: Before and after the exercise training or weight loss intervention. ] [ Designated as safety issue: No ]
  • Body composition and fitness [ Time Frame: Before and after the exercise training or weight loss intervention. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Exercise and Inflammation in the Elderly
Exercise, Inflammation and Pro-thrombotic Modulators 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.

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

  1. adipokine secretion and expression (tumor necrosis factor alpha, adiponectin);
  2. adipose tissue and skeletal muscle inflammatory proximal receptor expression (adiponectin receptor 1 and 2 and tumor necrosis factor alpha expression) and intermediate signaling pathways, and the terminal inhibitory action on insulin receptor substrate-1 tyrosine phosphorylation; and
  3. whether the changes in ligand concentrations, receptor expression, and signal transduction are associated with changes in peripheral (whole body insulin sensitivity by a hyperinsulinemic-euglycemic clamp), hepatic (hepatic glucose production), and cell-type specific (insulin stimulated glucose transport in adipocytes) insulin sensitivity.

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.

Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Inflammation
  • Insulin Sensitivity
  • Other: Weight Loss
    6 months of weight loss
  • Other: Aerobic Exercise Training
    6 months of aerobic exercise training
  • Experimental: Arm 1
    6 months of aerobic exercise training
    Intervention: Other: Aerobic Exercise Training
  • Experimental: Arm 2
    6 months of weight loss
    Intervention: Other: Weight Loss
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
November 2016
November 2012   (final data collection date for primary outcome measure)

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
45 Years to 80 Years
Contact information is only displayed when the study is recruiting subjects
United States
Department of Veterans Affairs
Department of Veterans Affairs
  • University of Maryland
  • Johns Hopkins University
Principal Investigator: Alice Ryan, PhD VA Maryland Health Care System, Baltimore
Department of Veterans Affairs
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP