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Exercise and Inflammation in the Elderly (IRIS)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00753363
First Posted: September 16, 2008
Last Update Posted: June 8, 2017
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.
Collaborators:
University of Maryland
Johns Hopkins University
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
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.

Condition Intervention
Inflammation Insulin Sensitivity Other: Weight Loss Other: Aerobic Exercise Training

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Exercise, Inflammation and Pro-thrombotic Modulators in the Elderly

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Body Weight [ Time Frame: Baseline and 6 month ]
  • Fitness [ Time Frame: Baseline and 6 month ]
    Maximal oxygen consumption (VO2max) on a treadmill


Enrollment: 119
Actual Study Start Date: April 1, 2007
Estimated Study Completion Date: November 29, 2017
Primary Completion Date: November 29, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
6 months of aerobic exercise training
Other: Aerobic Exercise Training
6 months of aerobic exercise training
Experimental: Arm 2
6 months of weight loss
Other: Weight Loss
6 months of weight loss

Detailed Description:

This study will compare the effects of 6 month 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 and tumor necrosis factor alpha expression) and signaling pathways; and
  3. 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.

  Eligibility

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:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00753363


Locations
United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
VA Office of Research and Development
University of Maryland
Johns Hopkins University
Investigators
Principal Investigator: Alice S Ryan, PhD Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00753363     History of Changes
Other Study ID Numbers: AGCG-003-05F
First Submitted: September 12, 2008
First Posted: September 16, 2008
Results First Submitted: October 15, 2014
Results First Posted: December 22, 2014
Last Update Posted: June 8, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Glucose Metabolism

Additional relevant MeSH terms:
Inflammation
Insulin Resistance
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases