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Caloric Restriction, Exercise, and Glucoregulation in Humans (CREG)

This study has been completed.
Sponsor:
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
October 21, 2008
February 11, 2016
April 2008
March 2015   (Final data collection date for primary outcome measure)
Glucoregulatory function [ Time Frame: 3-4 months ]
Same as current
Complete list of historical versions of study NCT00777621 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Caloric Restriction, Exercise, and Glucoregulation in Humans
Caloric Restriction, Exercise, and Glucoregulation in Humans
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Diabetes
  • Other: Calorie Restriction
    This group will undergo a 20% reduction in energy intake without any change in energy expenditure.
  • Other: Exercise
    This group will undergo a 20% increase in energy expenditure by exercising without any change in energy intake.
  • Other: Calorie Restriction and Exercise
    This group will undergo 10% reduction in energy intake and a 10% increase in energy expenditure via exercise.
  • Active Comparator: Calorie restriction
    Intervention: Other: Calorie Restriction
  • Active Comparator: Exercise
    Intervention: Other: Exercise
  • Experimental: Calorie restriction and exercise
    Intervention: Other: Calorie Restriction and Exercise

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
69
March 2015
March 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
45 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00777621
K01DK080886
K01DK080886 ( US NIH Grant/Contract Award Number )
1K01DK080886-01 ( US NIH Grant/Contract Award Number )
No
Not Provided
Not Provided
Not Provided
Edward Weiss, Ph.D., St. Louis University
St. Louis University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Edward P Weiss, PhD St. Louis University
St. Louis University
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP