Metabolically Normal and Metabolically Abnormal Obesity

The Washington University

Status: Completed

Conditions: Obesity; Metabolic Syndrome

Treatments: Behavioral: overfeeding

Study type: Interventional

Funder types: Other

Identifiers

NCT01184170

10-0708

Details and patient eligibility

About

The purpose of this study is to learn more about why some obese persons are resistant to developing obesity-related metabolic diseases (such as diabetes and cardiovascular disease), while others are prone to developing these conditions. We will do this by studying obese persons before and after a 5% body weight gain.

Subjects will be asked to increase their current diet for a period of 8-12 weeks in order to increase their current body weight by 5%. Each will then be asked to maintain this weight increase for 3 weeks. We will monitor subjects throughout this time period with weekly medical evaluations. At the completion of the study, we will provide each subject with a 6-month weight loss program.

Enrollment: 71 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Obese subjects (BMI 30.0 - 39.9 kg/m2)
• Sedentary subjects (exercise less than 1 hr/wk)

Exclusion criteria

• Pregnant or lactating women
• Michigan Alcohol Screening Test score ≥4
• Active or previous history of liver disease
• Active or previous history of diabetes
• history of alcohol abuse, or currently consuming ≥20 g alcohol/day
• Severe hypertriglyceridemia (>300 mg/dL)
• Smoke tobacco
• Take medication that might confound the study results

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

Metabolically Normal

Experimental group

Description:

Subjects in this group are metabolically normal. They have low liver fat defined as less than five percent as determined by magnetic resonance spectroscopy. Intervention: Subjects will begin an 8-12 week high-calorie diet intervention. They will eat an additional 1000 kcal/day for two to three months, until a moderate, approximately 5% weight gain is achieved. The recommended dietary energy intake will be 1000 kcal/d more than the subject's baseline resting energy expenditure. An individualized diet plan will be developed for each subject by the study dietitian based on estimated energy requirements, and the subject's food preferences and dietary habits.

Treatment:

Behavioral: overfeeding

Metabolically Abnormal

Experimental group

Description:

Subjects in this group are metabolically abnormal. They have high liver fat defined as at least ten percent as determined by magnetic resonance spectroscopy. Intervention: Subjects will begin an 8-12 week high-calorie diet intervention. They will eat an additional 1000 kcal/day for two to three months, until a moderate, approximately 5% weight gain is achieved. The recommended dietary energy intake will be 1000 kcal/d more than the subject's baseline resting energy expenditure. An individualized diet plan will be developed for each subject by the study dietitian based on estimated energy requirements, and the subject's food preferences and dietary habits.

Treatment:

Behavioral: overfeeding