Status:
WITHDRAWN
Metabolic and Neural Adaptations to Weight Loss, Plateau, and Regain
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Brief Summary
Background: \- Many people can lose weight by changing their diet or exercise. However, most people eventually regain the weight over time. This weight regain may be related to changes in metabolism ...
Detailed Description
Lifestyle interventions can result in weight loss, but most people experience a plateau after 6-10 months when weight stabilizes and many subsequently regain weight over the subsequent months. This pa...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age 18-55 years, male and female
- Recent weight stability (\< plus and minus 2 % over past 1 month)
- Body mass index (BMI) greater than or equal to 30 kg/m2
- Able to complete daily bouts of moderate to vigorous exercise (when applicable)
- Written informed consent
- Have reserved a stay of at least 4 weeks at The Biggest Loser Resort or have enrolled in a structured meal replacement weight loss program at the Washington Center for Weight Management and Research, the National Center for Weight and Wellness, or the Johns Hopkins Weight Management Center.
- EXCLUSION CRITERIA:
- Body weight \> 400 lbs (weight limit of PET and MRI scanners)
- BMI \< 30 kg/m2
- Less than 80% of maximum lifetime weight
- Hypertension if
- (1) \>160/100;
- (2) 140/90 to 159/99 with evidence of target organ damage (e.g. elevated serum creatinine, proteinuria, abnormal EKG, retinopathy);
- (3) \>140/90 on antihypertensive medications.
- Evidence of metabolic or cardiovascular disease, or disease that may influence metabolism (e.g. cancer, thyroid disease)
- Past or present history of eating disorder (including binge eating) or psychiatric disease
- Taking any prescription medication or other drug that may influence metabolism (e.g. diet/weight-loss medication, asthma medication, psychiatric medications, corticosteroids, or other medications at the discretion of the PI and/or study team)
- Hematocrit \< 34% (women only)
- Hematocrit \< 40% (men only)
- Pregnancy, lactation (women only)
- Women who become pregnant during the two-year study period
- Recent participation in a regular exercise program (\> 4h/week of vigorous activity)
- Previous bariatric surgery
- Caffeine consumption \> 500 mg/day
- Regular use of alcohol (\>2 drinks per day), tobacco (smoking or chewing) amphetamines, cocaine, heroin, or marijuana over past 6 months
- Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, multiple food allergies)
- Having metal implants incompatible with MRI (for example, pacemakers, metallic prostheses such as cochlear implants or heart valves, shrapnel fragments, etc.).
- Non-native English speakers
- Volunteers unwilling or unable to give informed consent
Exclusion
Key Trial Info
Start Date :
July 21 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 29 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02199483
Start Date
July 21 2014
End Date
June 29 2017
Last Update
December 12 2019
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