Metabolically Normal and Metabolically Abnormal Obesity

Obesity Clinical Trial

Official title:

Metabolically Normal and Metabolically Abnormal Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01184170
• Other study ID #: 10-0708
• Status: Completed
• Phase: N/A
• First received: August 12, 2010
• Last updated: June 29, 2017
• Start date: August 2010
• Est. completion date: February 2015

Study information

• Verified date: June 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: February 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity

Intervention

Behavioral:
• overfeeding
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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Intrahepatic Triglyceride		an average of three months, from baseline to 5% weight gain
Primary	Change in de novo lipogenesis		an average of three months, from baseline to 5% weight gain
Primary	Change in VLDL kinetics		an average of three months, from baseline to 5% weight gain
Primary	Change in hepatic insulin sensitivity		an average of three months, from baseline to 5% weight gain
Primary	Change in skeletal muscle insulin sensitivity		an average of three months, from baseline to 5% weight gain
Secondary	Change in adipose tissue insulin sensitivity		an average of three months, from baseline to 5% weight gain
Secondary	Change in CD36 concentration in skeletal muscle		an average of three months, from baseline to 5% weight gain
Secondary	change in CD36 concentration in adipose tissue		an average of three months, from baseline to 5% weight gain
Secondary	Change in cell proliferation (growth) rates in the colon		an average of three months, from baseline to 5% weight gain