Status:
COMPLETED
Exercise Dose-Response Effects in Prediabetes
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Pre-Diabetes
Eligibility:
All Genders
45-75 years
Phase:
NA
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...
Detailed Description
729 subjects were consented, 288 participants were randomized.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT00962962
Start Date
July 1 2009
End Date
August 1 2013
Last Update
July 15 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Duke Center For Living
Durham, North Carolina, United States, 27710