Metabolically Normal and Metabolically Abnormal Obesity

Not Applicable

Completed

• Conditions: Obesity; Metabolic Syndrome

• 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

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