Exercise Dose-Response Effects in Prediabetes

Pre-Diabetes Clinical Trial

— STRRIDE-PD  

Official title:

Exercise Dose-Response Effects in Prediabetes: Responses and Mechanisms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00962962
• Other study ID #: Pro00012628
• Secondary ID: R01DK081559
• Status: Completed
• Phase: N/A
• First received: August 19, 2009
• Last updated: July 14, 2014
• Start date: July 2009
• Est. completion date: August 2013

Study information

• Verified date: September 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

729 subjects were consented, 288 participants were randomized.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pre-Diabetes

Intervention

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
• 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
• 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
• 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.

Locations

Country	Name	City	State
United States	Duke Center For Living	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting Plasma Glucose		3 month control and 6 months intervention	No
Secondary	Measures of Glucose control		3 month control and 6 month intervention	No

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