Caloric Restriction, Exercise, and Glucoregulation in Humans

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Other: Calorie Restriction; Other: Calorie Restriction and Exercise; Other: Exercise

• Registration Number: NCT00777621
• Lead Sponsor: St. Louis University

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 Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-10-21
• Study First Submitted QC: 2008-10-21
• Study First Posted: 2008-10-22
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-11
• Last Update Posted: 2016-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• females postmenopausal
• no diabetes, cardiovascular disease, cancer
• no orthopedic problems
• not currently exercising
• BMI between 25 and 29.9
• nonsmokers

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Exclusion Criteria

• current regular exercisers
• premenopausal women
• cardiovascular disease, lung disease, cancer, diabetes

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calorie restriction	Calorie Restriction	-
Calorie restriction and exercise	Calorie Restriction and Exercise	-
Exercise	Exercise	-

Primary Outcome Measures

Name	Time	Method
Glucoregulatory function	3-4 months

Trial Locations

Locations (1)

Saint Louis University; 🇺🇸 Saint Louis, Missouri, United States