Metabolically Normal and Metabolically Abnormal Obesity

Not Applicable

Completed

• Conditions: Obesity; Metabolic Syndrome
• Interventions: Behavioral: overfeeding

• Registration Number: NCT01184170
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-12
• Study First Submitted QC: 2010-08-17
• Study First Posted: 2010-08-18
• Primary Completion: 2014-08
• Study Completion: 2015-02
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-29
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metabolically Normal	overfeeding	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.
Metabolically Abnormal	overfeeding	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.

Primary Outcome Measures

Name	Time	Method
Change in skeletal muscle insulin sensitivity	an average of three months, from baseline to 5% weight gain
Change in hepatic insulin sensitivity	an average of three months, from baseline to 5% weight gain
Change in de novo lipogenesis	an average of three months, from baseline to 5% weight gain
Change in Intrahepatic Triglyceride	an average of three months, from baseline to 5% weight gain
Change in VLDL kinetics	an average of three months, from baseline to 5% weight gain

Secondary Outcome Measures

Name	Time	Method
Change in adipose tissue insulin sensitivity	an average of three months, from baseline to 5% weight gain
Change in CD36 concentration in skeletal muscle	an average of three months, from baseline to 5% weight gain
Change in cell proliferation (growth) rates in the colon	an average of three months, from baseline to 5% weight gain
change in CD36 concentration in adipose tissue	an average of three months, from baseline to 5% weight gain

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States