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Exercise and Inflammation in the Elderly (IRIS)

Primary Purpose

Inflammation, Insulin Sensitivity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight Loss
Aerobic Exercise Training
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammation focused on measuring Glucose Metabolism

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

6 months of aerobic exercise training

6 months of weight loss

Outcomes

Primary Outcome Measures

Insulin Sensitivity
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
Fitness
Maximal oxygen consumption (VO2max) on a treadmill

Full Information

First Posted
September 12, 2008
Last Updated
March 29, 2018
Sponsor
VA Office of Research and Development
Collaborators
University of Maryland, Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT00753363
Brief Title
Exercise and Inflammation in the Elderly
Acronym
IRIS
Official Title
Exercise, Inflammation and Pro-thrombotic Modulators in the Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2007 (Actual)
Primary Completion Date
November 29, 2012 (Actual)
Study Completion Date
November 29, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
University of Maryland, Johns Hopkins University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Insulin Sensitivity
Keywords
Glucose Metabolism

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
6 months of aerobic exercise training
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
6 months of weight loss
Intervention Type
Other
Intervention Name(s)
Weight Loss
Intervention Description
6 months of weight loss
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise Training
Intervention Description
6 months of aerobic exercise training
Primary Outcome Measure Information:
Title
Insulin Sensitivity
Description
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.
Time Frame
Baseline and 6 month
Secondary Outcome Measure Information:
Title
Body Weight
Time Frame
Baseline and 6 month
Title
Fitness
Description
Maximal oxygen consumption (VO2max) on a treadmill
Time Frame
Baseline and 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice S Ryan, PhD
Organizational Affiliation
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Exercise and Inflammation in the Elderly

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