Exercise Dose-Response Effects in Prediabetes
STRRIDE-PD
2 other identifiers
interventional
288
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 19, 2009
CompletedFirst Posted
Study publicly available on registry
August 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedJuly 15, 2014
September 1, 2013
4.1 years
August 19, 2009
July 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fasting Plasma Glucose
3 month control and 6 months intervention
Secondary Outcomes (1)
Measures of Glucose control
3 month control and 6 month intervention
Study Arms (4)
Low-Amount/Moderate Intensity Exercise
OTHERAerobic 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
OTHERAerobic 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
OTHERAerobic 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
OTHER* 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.
Interventions
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
* 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Duke Center For Living
Durham, North Carolina, 27710, United States
Related Publications (5)
Jiang R, Collins KA, Huffman KM, Hauser ER, Hubal MJ, Johnson JL, Williams RB, Siegler IC, Kraus WE. Genome-Wide Genetic Analysis of Dropout in a Controlled Exercise Intervention in Sedentary Adults With Overweight or Obesity and Cardiometabolic Disease. Ann Behav Med. 2024 Apr 11;58(5):363-374. doi: 10.1093/abm/kaae011.
PMID: 38489667DERIVEDBennett WC, Collins KA, Johnson JL, Slentz CA, Willis LH, Bales CW, Huffman KM, Kraus WE. Effects of exercise amount and intensity versus a combined exercise and lifestyle intervention on metabolic syndrome in adults with prediabetes: a STRRIDE-PD randomized trial. Front Physiol. 2023 Jul 14;14:1199763. doi: 10.3389/fphys.2023.1199763. eCollection 2023.
PMID: 37520827DERIVEDSarzynski 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.
PMID: 29437573DERIVEDBartlett 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.
PMID: 28642810DERIVEDSlentz 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.
PMID: 27421729DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William E Kraus, MD
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2009
First Posted
August 20, 2009
Study Start
July 1, 2009
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
July 15, 2014
Record last verified: 2013-09