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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pre-Diabetes | Behavioral: Aerobic Exercise Behavioral: Exercise and Diet | Not Applicable |
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 |
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
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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
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Behavioral: Exercise and Diet
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- Fasting Plasma Glucose [ Time Frame: 3 month control and 6 months intervention ]
- Measures of Glucose control [ Time Frame: 3 month control and 6 month intervention ]

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Ages Eligible for Study: | 45 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, North Carolina | |
Duke Center For Living | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | William E Kraus, MD | Duke University |
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 |