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

Primary Purpose

Pre-Diabetes

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Aerobic Exercise

Exercise and Diet

About this trial

This is an interventional prevention trial for Pre-Diabetes focused on measuring Abnormal fasting glucose

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Duke Center For Living

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Arm Label

Low-Amount/Moderate Intensity Exercise

High-Amount/Moderate-Intensity Exercise

High-Amount/Vigorous-Intensity Exercise

Low-Amount/Moderate-Intensity Exercise + Diet

Arm Description

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 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 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 - 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.

Outcomes

Primary Outcome Measures

Fasting Plasma Glucose

Secondary Outcome Measures

Measures of Glucose control

Full Information

NCT ID

NCT00962962

First Posted

August 19, 2009

Last Updated

July 14, 2014

Sponsor

Duke University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT00962962

Brief Title

Exercise Dose-Response Effects in Prediabetes

Acronym

STRRIDE-PD

Official Title

Exercise Dose-Response Effects in Prediabetes: Responses and Mechanisms

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

Detailed Description

729 subjects were consented, 288 participants were randomized.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pre-Diabetes

Keywords

Abnormal fasting glucose

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

288 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low-Amount/Moderate Intensity Exercise

Arm Type

Other

Arm Description

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

Arm Title

High-Amount/Moderate-Intensity Exercise

Arm Type

Other

Arm Description

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

Arm Title

High-Amount/Vigorous-Intensity Exercise

Arm Type

Other

Arm Description

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

Arm Title

Low-Amount/Moderate-Intensity Exercise + Diet

Arm Type

Other

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Aerobic Exercise

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Aerobic Exercise

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Aerobic Exercise

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Exercise and Diet

Intervention Description

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.

Primary Outcome Measure Information:

Title

Fasting Plasma Glucose

Time Frame

3 month control and 6 months intervention

Secondary Outcome Measure Information:

Title

Measures of Glucose control

Time Frame

3 month control and 6 month intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William E Kraus, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke Center For Living

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

29437573

Citation

Sarzynski MA, Ruiz-Ramie JJ, Barber JL, Slentz CA, Apolzan JW, McGarrah RW, Harris MN, Church TS, Borja MS, He Y, Oda MN, Martin CK, Kraus WE, Rohatgi A. Effects of Increasing Exercise Intensity and Dose on Multiple Measures of HDL (High-Density Lipoprotein) Function. Arterioscler Thromb Vasc Biol. 2018 Apr;38(4):943-952. doi: 10.1161/ATVBAHA.117.310307. Epub 2018 Feb 8. Erratum In: Arterioscler Thromb Vasc Biol. 2018 Jul;38(7):e136.

Results Reference

derived

PubMed Identifier

28642810

Citation

Bartlett DB, Slentz CA, Connelly MA, Piner LW, Willis LH, Bateman LA, Granville EO, Bales CW, Huffman KM, Kraus WE. Association of the Composite Inflammatory Biomarker GlycA, with Exercise-Induced Changes in Body Habitus in Men and Women with Prediabetes. Oxid Med Cell Longev. 2017;2017:5608287. doi: 10.1155/2017/5608287. Epub 2017 May 31.

Results Reference

derived

PubMed Identifier

27421729

Citation

Slentz CA, Bateman LA, Willis LH, Granville EO, Piner LW, Samsa GP, Setji TL, Muehlbauer MJ, Huffman KM, Bales CW, Kraus WE. Effects of exercise training alone vs a combined exercise and nutritional lifestyle intervention on glucose homeostasis in prediabetic individuals: a randomised controlled trial. Diabetologia. 2016 Oct;59(10):2088-98. doi: 10.1007/s00125-016-4051-z. Epub 2016 Jul 15.

Results Reference

derived

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Exercise Dose-Response Effects in Prediabetes

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