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Completed

NCT Number: NCT00777621

Caloric Restriction, Exercise, and Glucoregulation in Humans

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Louis University

St Louis, Missouri, 63104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calorie Restriction

Other

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

Exercise

Other

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

Calorie Restriction and Exercise

Other

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

Primary outcomes

  1. Glucoregulatory function

    Time frame: 3-4 months

Sponsors and collaborators

Lead sponsor

St. Louis University

Other

Collaborators

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

Registry information

Acronym: CREG

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Oct 22, 2008
Registry last updated
Feb 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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