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

This study is currently recruiting participants.
Verified December 2012 by Duke University
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00962962
First received: August 19, 2009
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention Phase
Pre-Diabetes
 Behavioral: Aerobic Exercise
Behavioral: Exercise and Diet
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Exercise Dose-Response Effects in Prediabetes: Responses and Mechanisms

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Fasting Plasma Glucose [ Time Frame: 3 month control and 6 months intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measures of Glucose control [ Time Frame: 3 month control and 6 month intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: July 2009
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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.

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
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

    o Readings from two separate days, both being > 95 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 use: > 18.0 - < 40.0 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00962962

Contacts
Contact: Lori A Bateman, MS 919-660-6785 lori.bateman@duke.edu
Contact: William E Kraus, MD 919-660-6613 william.kraus@duke.edu

Locations
United States, North Carolina
Duke Center For Living Recruiting
Durham, North Carolina, United States, 27710
Contact: Lori A Bateman, MS     919-660-6785     lori.bateman@duke.edu    
Contact: Cris A Slentz, PhD     919-660-6743     cris.slentz@duke.edu    
Principal Investigator: William E. Kraus, MD            
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

Additional Information:
Click on Clinical Research tab  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00962962     History of Changes
Other Study ID Numbers: Pro00012628 (DK81559), R01DK081559
Study First Received: August 19, 2009
Last Updated: December 10, 2012
Health Authority: United States: Federal Government

Keywords provided by Duke University:
Abnormal fasting glucose

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

ClinicalTrials.gov processed this record on May 21, 2013