Caloric Restriction, Exercise, and Glucoregulation in Humans (CREG)

Saint Louis University (SLU)

Status: Completed

Conditions: Diabetes

Treatments: Other: Calorie Restriction and Exercise; Other: Exercise; Other: Calorie Restriction

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00777621

K01DK080886 (U.S. NIH Grant/Contract)

1K01DK080886-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 69 patients

Sex: All

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 3 patient groups

Calorie restriction

Active Comparator group

Treatment:

Other: Calorie Restriction

Exercise

Active Comparator group

Treatment:

Other: Exercise

Calorie restriction and exercise

Experimental group

Treatment:

Other: Calorie Restriction and Exercise