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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
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Edward Weiss, Ph.D., St. Louis University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Other: Calorie Restriction Other: Exercise Other: Calorie Restriction and Exercise Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Caloric Restriction, Exercise, and Glucoregulation in Humans
Study Start Date : April 2008
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Glucoregulatory function [ Time Frame: 3-4 months ]

Eligibility Criteria
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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older 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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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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 ( U.S. NIH Grant/Contract )
K01DK080886 ( U.S. NIH Grant/Contract )
1K01DK080886-01 ( U.S. NIH Grant/Contract )
First Posted: October 22, 2008    Key Record Dates
Last Update Posted: February 12, 2016
Last Verified: February 2016