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

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ClinicalTrials.gov Identifier: NCT00962962
Recruitment Status : Completed
First Posted : August 20, 2009
Last Update Posted : July 15, 2014
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Duke University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pre-Diabetes Behavioral: Aerobic Exercise Behavioral: Exercise and Diet Not Applicable

Detailed Description:
729 subjects were consented, 288 participants were randomized.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Exercise Dose-Response Effects in Prediabetes: Responses and Mechanisms
Study Start Date : July 2009
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
 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
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
 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
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
 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
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Fasting Plasma Glucose [ Time Frame: 3 month control and 6 months intervention ]

Secondary Outcome Measures :
  1. Measures of Glucose control [ Time Frame: 3 month control and 6 month intervention ]

Eligibility Criteria
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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT00962962


Locations
United States, North Carolina
Duke Center For Living
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: William E Kraus, MD Duke University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00962962     History of Changes
Other Study ID Numbers: Pro00012628
R01DK081559 ( U.S. NIH Grant/Contract )
First Posted: August 20, 2009    Key Record Dates
Last Update Posted: July 15, 2014
Last Verified: September 2013

Keywords provided by Duke University:
Abnormal fasting glucose

Additional relevant MeSH terms:
Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Hyperglycemia