Caloric Restriction, Exercise, and Glucoregulation in Humans

NCT ID: NCT00777621

Last Updated: 2016-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2015-03-31

Brief Summary

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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

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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.

Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Calorie restriction

Group Type ACTIVE_COMPARATOR

Calorie Restriction

Intervention Type OTHER

This group will undergo a 20% reduction in energy intake without any change in energy expenditure.

Exercise

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type OTHER

This group will undergo a 20% increase in energy expenditure by exercising without any change in energy intake.

Calorie restriction and exercise

Group Type EXPERIMENTAL

Calorie Restriction and Exercise

Intervention Type OTHER

This group will undergo 10% reduction in energy intake and a 10% increase in energy expenditure via exercise.

Interventions

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Calorie Restriction

This group will undergo a 20% reduction in energy intake without any change in energy expenditure.

Intervention Type OTHER

Exercise

This group will undergo a 20% increase in energy expenditure by exercising without any change in energy intake.

Intervention Type OTHER

Calorie Restriction and Exercise

This group will undergo 10% reduction in energy intake and a 10% increase in energy expenditure via exercise.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

St. Louis University

OTHER

Sponsor Role lead

Responsible Party

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Edward Weiss, Ph.D.

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Edward P Weiss, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Louis University

Locations

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Saint Louis University

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 27580151 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27465384 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25877812 (View on PubMed)

Other Identifiers

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K01DK080886

Identifier Type: NIH

Identifier Source: secondary_id

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1K01DK080886-01

Identifier Type: NIH

Identifier Source: secondary_id

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K01DK080886

Identifier Type: NIH

Identifier Source: org_study_id

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