Exercise Dose-Response Effects in Prediabetes (STRRIDE-PD)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00962962
First received: August 19, 2009
Last updated: July 14, 2014
Last verified: September 2013

August 19, 2009
July 14, 2014
July 2009
August 2013   (final data collection date for primary outcome measure)
Fasting Plasma Glucose [ Time Frame: 3 month control and 6 months intervention ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00962962 on ClinicalTrials.gov Archive Site
Measures of Glucose control [ Time Frame: 3 month control and 6 month intervention ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Exercise Dose-Response Effects in Prediabetes
Exercise Dose-Response Effects in Prediabetes: Responses and Mechanisms

The purpose of the study is to evaluate the effects of different amounts and intensities of aerobic exercise training programs, with and without weight loss, in people who are at risk for diabetes. An additional purpose of the study is to evaluate the factors in the blood and in exercising muscles that contribute to the improvement in those risk factors. This information will be used to improve exercise training guidelines for improving cardiovascular and metabolic health in people with abnormal fasting glucose, also known as prediabetes.

729 subjects were consented, 288 participants were randomized.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Pre-Diabetes
  • Behavioral: Aerobic Exercise
    Aerobic exercise at 50% peak oxygen use/consumption expending approximately 1,000 calories per week equaling approximately 10 miles per week OR 2.5-3.5 hours per week
  • Behavioral: Aerobic Exercise
    Aerobic exercise at 50% peak oxygen use/consumption expending approximately 1,600 calories per week equaling approximately 16 miles per week OR 4-6 hours per week
  • Behavioral: Aerobic Exercise
    Aerobic exercise at 75% peak oxygen use/consumption expending approximately 1,600 calories per week equaling approximately 16 miles per week OR 2-3 hours per week
  • Behavioral: Exercise and Diet
    • Exercise - 150 minutes per week (30 minutes / 5 days per week) of aerobic exercise at 50% peak oxygen use/consumption equaling approximately 10 miles per week
    • Diet - The Clinical Lifestyle Intervention sessions will provide training on needed skills (e.g., calorie counting, portion size estimation) as well as motivation and support in a group counseling setting designed to achieve a weight loss goal of 5 to 7% of baseline body weight.
  • Low-Amount/Moderate Intensity Exercise
    Aerobic exercise at 50% peak oxygen use/consumption expending approximately 1,000 calories per week equaling approximately 10 miles per week OR 2.5-3.5 hours per week
    Intervention: Behavioral: Aerobic Exercise
  • High-Amount/Moderate-Intensity Exercise
    Aerobic exercise at 50% peak oxygen use/consumption expending approximately 1,600 calories per week equaling approximately 16 miles per week OR 4-6 hours per week
    Intervention: Behavioral: Aerobic Exercise
  • High-Amount/Vigorous-Intensity Exercise
    Aerobic exercise at 75% peak oxygen use/consumption expending approximately 1,600 calories per week equaling approximately 16 miles per week OR 2-3 hours per week
    Intervention: Behavioral: Aerobic Exercise
  • Low-Amount/Moderate-Intensity Exercise + Diet
    • Exercise - 150 minutes per week (30 minutes / 5 days per week) of aerobic exercise at 50% peak oxygen use/consumption equaling approximately 10 miles per week
    • Diet - The CLI sessions will provide training on needed skills (e.g., calorie counting, portion size estimation) as well as motivation and support in a group counseling setting designed to achieve a weight loss goal of 5 to 7% of baseline body weight.
    Intervention: Behavioral: Exercise and Diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
288
August 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age: 45-75 years
  • Moderately Overweight determined by Body Mass Index: 25.0 - 35.4
  • Fasting plasma glucose: > 95 - < 126 mg/dL until 2/15/2012 when lower limit was adjusted to > 100 mg/dL

    o Readings from two separate days, both being > 95 (> 100 after 2/15/2012)and one of the two being < 126

  • Low density (LDL) cholesterol: < 190 mg/dL
  • Triglycerides: < 600 mg/dL
  • Resting blood pressure: < 160/90 mmHg
  • Inactive: Exercise < one day/week; Peak oxygen consumption: > 18.0 - < 40.0 ml/kg/min until 2/15/2012 when lower limit was adjusted to 12.0 ml/kg/min
  • Medications: Stable use of all medications for > three months

Exclusion Criteria:

  • Smoker: Tobacco use within the last 12 months
  • Dieting or intending to diet
  • Use of potential confounding medications, e.g. Niacin containing drugs
  • History of diabetes, heart disease or taking medication for those conditions
  • History of hypertension (high blood pressure) not controlled with medication
  • Pregnant or intending to become pregnant
  • Unwillingness to undergo a three month control/run-in period, be randomized to any one of four intervention groups, submit to thigh muscle biopsies and all other study testing or continuously participate in a randomly assigned exercise training or lifestyle intervention program for six months
  • Orthopedic limitations, musculoskeletal disease and/or injury
  • Allergic to xylocaine (anesthetic or numbing medicine)
  • Inability to give blood continuously through a catheter (please notify the study nurse of any difficulty you have experienced in the past when having your blood drawn; the study nurse will determine whether you are excluded for this reason)
  • Unwillingness to exercise at least twice per week at the Duke Center for Living Health and Fitness Center during research study staff supervised times
Both
45 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00962962
Pro00012628, R01DK081559
No
Duke University
Duke University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: William E Kraus, MD Duke University
Duke University
September 2013

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