An interventional study of Aerobic Exercise and Aerobic Exercise in Pre-Diabetes, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-07-15.
Sponsored by Duke University · Not applicable, Interventional, and Prevention
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.
729 subjects were consented, 288 participants were randomized.
999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.
This study's enrollment of 288 is above the median of 65 across 844 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
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
Behavioral: Aerobic Exercise
* 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
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 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.
Fasting Plasma Glucose
Time frame: 3 month control and 6 months intervention
Measures of Glucose control
Time frame: 3 month control and 6 month intervention
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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Duke University