Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
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Caloric Restriction, Exercise, and Glucoregulation in Humans (CREG)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
St. Louis University
ClinicalTrials.gov Identifier:
NCT00777621
First received: October 21, 2008
Last updated: March 4, 2014
Last verified: March 2014
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by St. Louis University:

Primary Outcome Measures:
  • Glucoregulatory function [ Time Frame: 3-4 months ] [ Designated as safety issue: No ]
Estimated Enrollment: 60
Study Start Date: April 2008
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2014 (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, 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, dual X-ray absorptiometry (DEXA) for bone density and lean body mass, lung diffusion, and cardiac output/lung capacity.

  Eligibility
Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: St. Louis University
ClinicalTrials.gov Identifier: NCT00777621     History of Changes
Other Study ID Numbers: K01 DK80886, K01DK080886, 1K01DK080886-01
Study First Received: October 21, 2008
Last Updated: March 4, 2014
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on February 27, 2015