Metabolic Syndrome, Obesity
Conditions
Keywords
obesity, metabolism, cardiovascular metabolic syndrome
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.
Interventions
BEHAVIORALoverfeeding
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.
Sponsors
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in skeletal muscle insulin sensitivity | 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 de novo lipogenesis | 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 |
| Change in hepatic insulin sensitivity | an average of three months, from baseline to 5% weight gain |
Secondary
| Measure | Time frame |
|---|---|
| Change in CD36 concentration in skeletal muscle | 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 |
| Change in cell proliferation (growth) rates in the colon | an average of three months, from baseline to 5% weight gain |
| Change in adipose tissue insulin sensitivity | an average of three months, from baseline to 5% weight gain |
Countries
United States
Outcome results
None listed