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Caloric Restriction, Exercise, and Glucoregulation in Humans (CREG)
This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00777621
First received: October 21, 2008
Last updated: February 11, 2016
Last verified: February 2016
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Purpose
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.
| Condition | Intervention |
|---|---|
| Diabetes | Other: Calorie Restriction Other: Exercise Other: Calorie Restriction and Exercise |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Caloric Restriction, Exercise, and Glucoregulation in Humans |
Resource links provided by NLM:
Further study details as provided by Edward Weiss, Ph.D., St. Louis University:
Primary Outcome Measures:
- Glucoregulatory function [ Time Frame: 3-4 months ]
| Enrollment: | 69 |
| Study Start Date: | April 2008 |
| Study Completion Date: | March 2015 |
| Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Calorie restriction |
Other: Calorie Restriction
This group will undergo a 20% reduction in energy intake without any change in energy expenditure.
|
| Active Comparator: Exercise |
Other: Exercise
This group will undergo a 20% increase in energy expenditure by exercising without any change in energy intake.
|
| Experimental: Calorie restriction and exercise |
Other: Calorie Restriction and Exercise
This group will undergo 10% reduction in energy intake and a 10% increase in energy expenditure via exercise.
|
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.
Eligibility| Ages Eligible for Study: | 45 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- females postmenopausal
- no diabetes, cardiovascular disease, cancer
- no orthopedic problems
- not currently exercising
- BMI between 25 and 29.9
- nonsmokers
Exclusion Criteria:
- current regular exercisers
- premenopausal women
- cardiovascular disease, lung disease, cancer, diabetes
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00777621
Please refer to this study by its ClinicalTrials.gov identifier: NCT00777621
Locations
| United States, Missouri | |
| Saint Louis University | |
| Saint Louis, Missouri, United States, 63104 | |
Sponsors and Collaborators
St. Louis University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
| Principal Investigator: | Edward P Weiss, PhD | St. Louis University |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Edward Weiss, Ph.D., Associate Professor, St. Louis University |
| ClinicalTrials.gov Identifier: | NCT00777621 History of Changes |
| Other Study ID Numbers: |
K01DK080886 ( US NIH Grant/Contract Award Number ) 1K01DK080886-01 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | October 21, 2008 |
| Last Updated: | February 11, 2016 |
ClinicalTrials.gov processed this record on June 23, 2017