Caloric Restriction, Exercise, and Glucoregulation in Humans (CREG)
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ClinicalTrials.gov Identifier: NCT00777621 |
Recruitment Status :
Completed
First Posted : October 22, 2008
Last Update Posted : February 12, 2016
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Sponsor:
St. Louis University
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Edward Weiss, Ph.D., St. Louis University
Tracking Information | ||||
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First Submitted Date ICMJE | October 21, 2008 | |||
First Posted Date ICMJE | October 22, 2008 | |||
Last Update Posted Date | February 12, 2016 | |||
Study Start Date ICMJE | April 2008 | |||
Actual Primary Completion Date | March 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Glucoregulatory function [ Time Frame: 3-4 months ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Caloric Restriction, Exercise, and Glucoregulation in Humans | |||
Official Title ICMJE | Caloric Restriction, Exercise, and Glucoregulation in Humans | |||
Brief Summary | Weight loss induced by caloric restriction alone (CR) and by exercise alone (EX) result in similar effects on blood glucose and insulin. The purpose of this study is to assess the hypothesis that weight loss through caloric restriction plus exercise will result in greater improvements on glucose tolerance and insulin action than similar weight losses through CR or EX alone. | |||
Detailed Description | Participants are randomized into caloric restriction, exercise, and caloric restriction plus exercise weight loss groups. Measurements of blood glucose and insulin, oral glucose tolerance, and matched glucose infusion will be done at baseline and after weight loss of 6% of body weight. Other tests include maximal oxygen uptake (VO2max), strength tests, blood pressure, blood lipids, serum inflammatory markers, dual X-ray absorptiometry (DEXA) for bone density and body composition, physical activity levels, dietary intakes, and measures of arterial stiffness. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE | Diabetes | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
69 | |||
Original Estimated Enrollment ICMJE |
60 | |||
Actual Study Completion Date ICMJE | March 2015 | |||
Actual Primary Completion Date | March 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 45 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00777621 | |||
Other Study ID Numbers ICMJE | K01DK080886( U.S. NIH Grant/Contract ) K01DK080886 ( U.S. NIH Grant/Contract ) 1K01DK080886-01 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Edward Weiss, Ph.D., St. Louis University | |||
Original Responsible Party | Edward P. Weiss, PhD, Saint Louis University | |||
Current Study Sponsor ICMJE | St. Louis University | |||
Original Study Sponsor ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | |||
Collaborators ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | |||
Investigators ICMJE |
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PRS Account | St. Louis University | |||
Verification Date | February 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |