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

• ClinicalTrials.gov Identifier: NCT00777621
• Recruitment Status: Completed
• First Posted: October 22, 2008
• Last Update Posted: February 12, 2016
• 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

• First Submitted Date: October 21, 2008
• First Posted Date: October 22, 2008
• Last Update Posted Date: February 12, 2016
• Study Start Date: April 2008
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 21, 2008): Glucoregulatory function [ Time Frame: 3-4 months ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Caloric Restriction, Exercise, and Glucoregulation in Humans
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Diabetes

Intervention

• 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.

Study Arms

• 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

Publications *

• Weiss EP, Jordan RC, Frese EM, Albert SG, Villareal DT. Effects of Weight Loss on Lean Mass, Strength, Bone, and Aerobic Capacity. Med Sci Sports Exerc. 2017 Jan;49(1):206-217. doi: 10.1249/MSS.0000000000001074.
• Weiss EP, Albert SG, Reeds DN, Kress KS, McDaniel JL, Klein S, Villareal DT. Effects of matched weight loss from calorie restriction, exercise, or both on cardiovascular disease risk factors: a randomized intervention trial. Am J Clin Nutr. 2016 Sep;104(3):576-86. doi: 10.3945/ajcn.116.131391. Epub 2016 Jul 27.
• Weiss EP, Albert SG, Reeds DN, Kress KS, Ezekiel UR, McDaniel JL, Patterson BW, Klein S, Villareal DT. Calorie Restriction and Matched Weight Loss From Exercise: Independent and Additive Effects on Glucoregulation and the Incretin System in Overweight Women and Men. Diabetes Care. 2015 Jul;38(7):1253-62. doi: 10.2337/dc14-2913. Epub 2015 Apr 15.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 2, 2015): 69
• Original Estimated Enrollment (submitted: October 21, 2008): 60
• Actual Study Completion Date: March 2015
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 45 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00777621
• Other Study ID Numbers: K01DK080886( U.S. NIH Grant/Contract ); K01DK080886 ( U.S. NIH Grant/Contract ); 1K01DK080886-01 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: 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: St. Louis University
• Original Study Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Edward P Weiss, PhD; St. Louis University

• PRS Account: St. Louis University
• Verification Date: February 2016