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

Exercise Dose-Response Effects in Prediabetes: Responses and Mechanisms

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.

Study Overview

• Status: Completed
• Conditions: Pre-Diabetes
• Intervention / Treatment: Behavioral: Aerobic Exercise; Behavioral: Aerobic Exercise; Behavioral: Aerobic Exercise; Behavioral: Exercise and Diet

Detailed Description

729 subjects were consented, 288 participants were randomized.

• Study Type: Interventional
• Enrollment (Actual): 288
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Center for Living

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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; 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; 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
Other: 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 1,000 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 1,600 calories per week equaling approximately 16 miles per week OR 4-6 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
Other: 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 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 1,600 calories per week equaling approximately 16 miles per week OR 4-6 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
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fasting Plasma Glucose	3 month control and 6 months intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Measures of Glucose control	3 month control and 6 month intervention

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: William E Kraus, MD, Duke University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: August 19, 2009
• First Submitted That Met QC Criteria: August 19, 2009
• First Posted (Estimate): August 20, 2009

Study Record Updates

• Last Update Posted (Estimate): July 15, 2014
• Last Update Submitted That Met QC Criteria: July 14, 2014
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Abnormal fasting glucose
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: Pro00012628; R01DK081559 (U.S. NIH Grant/Contract)