Metabolically Normal and Metabolically Abnormal Obesity

Metabolically Normal and Metabolically Abnormal Obesity
This study is currently recruiting participants.
Verified on April 2011 by Washington University School of Medicine

First Received on August 12, 2010.  
Last Updated on April 11, 2011  
History of Changes
Sponsor: Washington University School of Medicine
Information provided by: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01184170
  Purpose

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 your current diet for a period of 8-12 weeks in order to increase your 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.

Condition Intervention
Obesity
Metabolic Syndrome
Behavioral: overfeeding

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Metabolically Normal and Metabolically Abnormal Obesity

Resource links provided by NLM:

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

  • Change in Intrahepatic Triglyceride [ Time Frame: an average of three months, from baseline to 5% weight gain ] [ Designated as safety issue: No ]
  • Change in de novo lipogenesis [ Time Frame: an average of three months, from baseline to 5% weight gain ] [ Designated as safety issue: No ]
  • Change in VLDL kinetics [ Time Frame: an average of three months, from baseline to 5% weight gain ] [ Designated as safety issue: No ]
  • Change in hepatic insulin sensitivity [ Time Frame: an average of three months, from baseline to 5% weight gain ] [ Designated as safety issue: No ]
  • Change in skeletal muscle insulin sensitivity [ Time Frame: an average of three months, from baseline to 5% weight gain ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

  • Change in adipose tissue insulin sensitivity [ Time Frame: an average of three months, from baseline to 5% weight gain ] [ Designated as safety issue: No ]
  • Change in CD36 concentration in skeletal muscle [ Time Frame: an average of three months, from baseline to 5% weight gain ] [ Designated as safety issue: No ]
  • change in CD36 concentration in adipose tissue [ Time Frame: an average of three months, from baseline to 5% weight gain ] [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: August 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions
Metabolically Normal: Experimental

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: Behavioral: overfeeding
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 Name: directed weight gain
Metabolically Abnormal: Experimental

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: Behavioral: overfeeding
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 Name: directed weight gain

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01184170

Contacts
Contact: Emily Jenkerson, B.A. 314-362-1000 jenkersone@msnotes.wustl.edu
Contact: Martha Hessler, B.A. 314-362-8703 mhessler@dom.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Emily Jenkerson            
Contact: Martha Hessler            
Principal Investigator: Samuel Klein, MD            
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Samuel Klein, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Samuel Klein, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01184170    
History of Changes
Other Study ID Numbers: 10-0708
Study First Received: August 12, 2010
Last Updated: April 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:

obesity
metabolism
cardiovascular metabolic syndrome

Additional relevant MeSH terms:

Obesity
Metabolic Syndrome X
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 28, 2011

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