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OpenTrials
Completed

NCT Number: NCT01184170

Metabolically Normal and Metabolically Abnormal Obesity

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.

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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Overfeeding

Behavioral

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

Primary outcomes

  1. Change in Intrahepatic Triglyceride

    Time frame: an average of three months, from baseline to 5% weight gain

  2. Change in de novo lipogenesis

    Time frame: an average of three months, from baseline to 5% weight gain

  3. Change in VLDL kinetics

    Time frame: an average of three months, from baseline to 5% weight gain

  4. Change in hepatic insulin sensitivity

    Time frame: an average of three months, from baseline to 5% weight gain

  5. Change in skeletal muscle insulin sensitivity

    Time frame: an average of three months, from baseline to 5% weight gain

Secondary outcomes

  1. Change in adipose tissue insulin sensitivity

    Time frame: an average of three months, from baseline to 5% weight gain

  2. Change in CD36 concentration in skeletal muscle

    Time frame: an average of three months, from baseline to 5% weight gain

  3. change in CD36 concentration in adipose tissue

    Time frame: an average of three months, from baseline to 5% weight gain

  4. Change in cell proliferation (growth) rates in the colon

    Time frame: an average of three months, from baseline to 5% weight gain

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Aug 18, 2010
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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