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

Tracking Information

First Received Date ^ICMJE

October 21, 2008

Last Updated Date

February 11, 2016

Start Date ^ICMJE

April 2008

Primary Completion Date

March 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Glucoregulatory function [ Time Frame: 3-4 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00777621 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Caloric Restriction, Exercise, and Glucoregulation in Humans

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Diabetes

Intervention ^ICMJE

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 Arm (s)

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, 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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2015

Primary Completion Date

March 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

45 Years to 65 Years (Adult)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00777621

Other Study ID Numbers ^ICMJE

K01DK080886, K01DK080886, 1K01DK080886-01

Has Data Monitoring Committee

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Edward Weiss, Ph.D., St. Louis University

Study Sponsor ^ICMJE

St. Louis University

Collaborators ^ICMJE

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators ^ICMJE

Principal Investigator:

Edward P Weiss, PhD

St. Louis University

Information Provided By

St. Louis University

Verification Date

February 2016

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

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