Exercise Dose-Response Effects in Prediabetes - Full Text View

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
Pre-Diabetes	Behavioral: Aerobic Exercise Behavioral: Exercise and Diet


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Exercise Dose-Response Effects in Prediabetes: Responses and Mechanisms

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Prediabetes

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 ]


Enrollment:	288
Study Start Date:	July 2009
Study Completion Date:	August 2013
Primary Completion Date:	August 2013 (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 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.

Detailed Description:

729 subjects were consented, 288 participants were randomized.

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 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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, R01DK081559
Study First Received:	August 19, 2009
Last Updated:	July 14, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:


Abnormal fasting glucose

ClinicalTrials.gov processed this record on February 27, 2015

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