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

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:

MedlinePlus related topics: Exercise and Physical Fitness

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 ]


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)
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Edward Weiss, Ph.D., Associate Professor, St. Louis University
ClinicalTrials.gov Identifier:	NCT00777621 History of Changes
Other Study ID Numbers:	K01DK080886 1K01DK080886-01
Study First Received:	October 21, 2008
Last Updated:	February 11, 2016
Health Authority:	United States: Federal Government

ClinicalTrials.gov processed this record on September 26, 2016

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