Caloric Restriction, Exercise, and Glucoregulation in Humans

Diabetes Clinical Trial

— CREG  

Official title:

Caloric Restriction, Exercise, and Glucoregulation in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00777621
• Other study ID #: K01DK080886
• Secondary ID: K01DK0808861K01D
• Status: Completed
• Phase: N/A
• First received: October 21, 2008
• Last updated: February 11, 2016
• Start date: April 2008
• Est. completion date: March 2015

Study information

• Verified date: February 2016
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes

Intervention

Other:
• Calorie Restriction
This group will undergo a 20% reduction in energy intake without any change in energy expenditure.
• Exercise
This group will undergo a 20% increase in energy expenditure by exercising without any change in energy intake.
• Calorie Restriction and Exercise
This group will undergo 10% reduction in energy intake and a 10% increase in energy expenditure via exercise.

Locations

Country	Name	City	State
United States	Saint Louis University	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
St. Louis University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucoregulatory function		3-4 months	No