Metabolically Normal and Metabolically Abnormal Obesity

June 29, 2017 updated by: Washington University School of Medicine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metabolically Normal

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.
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.
Other Names:
  • directed weight gain
Experimental: Metabolically Abnormal

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.
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.
Other Names:
  • directed weight gain

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

August 12, 2010

First Submitted That Met QC Criteria

August 17, 2010

First Posted (Estimate)

August 18, 2010

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 29, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-0708

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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