Clinical trial NCT00962962: Exercise Dose-Response Effects in Prediabetes
Official title: Exercise Dose-Response Effects in Prediabetes: Responses and Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-Diabetes
Keywords: Abnormal fasting glucose
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2009-08-20
Enrollment: 288
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Fasting Plasma Glucose
timeFrame: 3 month control and 6 months intervention
Secondary outcomes:
measure: Measures of Glucose control
timeFrame: 3 month control and 6 month intervention
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Center For Living
state: North Carolina
Study officials:
affiliation: Duke University
name: William E Kraus, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.