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| ID | Type | Description | Link |
|---|---|---|---|
| 07-DK-0077 |
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This study will describe the phenotype (physical and behavioral traits) of overweight and obese people. It will characterize the hormones, metabolism, food preferences, fitness and physical activity levels, sleep patterns and thought processes in people with and without weight problems. Genetic material will be collected for studies of the internal codes that influence body weight.
People over 18 years of age from all weight categories (lean, overweight, obese) who are reasonably healthy may be eligible for this study. Participants undergo the following tests and procedures:
Although complex metabolic, hormonal, and neural networks operate to control body weight, obesity is in most cases, the result of over-feeding and inactivity. In most obese patients, patterns of fundamental behavior determine the success or failure of weight loss interventions. Behavior is controlled to some degree by conscious decision making and is influenced by signals from the integrated networks involved in body weight regulation. The contributions of behavior, environment, socioeconomic status, physiology and genetics assure that no single therapeutic regimen will be successful in all obese individuals. In order to explore the factors that impede weight loss and result in weight regain, the obese phenotype and its variants must be defined. The purpose of this study is to detail hormonal, metabolic, cognitive and behavioral traits across the spectrum of weight categories utilizing the state-of the-art facilities of the Metabolic Units at the Mark O. Hatfield Clinical Research Center, NIH. Genetic material will be banked for analysis of phenotypic subgroups as they emerge.
Patients over the age of 18 are eligible for this study. While childhood obesity is an important public health issue, the variables of growth and hormonal controls will be delineated in separate studies. Over-weight and obese patients are encouraged to participate in as full an evaluation as feasible. Lean individuals will be recruited to create a normative database for body composition (dual energy x-ray absortiometry, air displacement plethysmography), energy expenditure (resting energy expenditure, 24h respiratory chamber and doubly labeled water) and other techniques used to study traits of importance. The study will be conducted in both the inpatient and outpatient setting and can include evaluation of hormones, diurnal variation, sleep, eating behavior and taste perception, physical fitness, psychological and neurocognitive functioning. Importantly, this protocol is the means by which pilot data are obtained to develop novel approaches and hypotheses for studying obesity and its associated traits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lean | Normal weight men and women over the age of 18 years with BMI greater than 18.5 and less than 25, who are reasonably healthy | ||
| obese | Obese men and women over the age of 18 years with BMI greater than 30, who are reasonably healthy | ||
| overweight | Overweight men and women over the age of 18 years with BMI greater than 25 and less than 30, who are reasonably healthy |
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| Measure | Description | Time Frame |
|---|---|---|
| Phenotype (physical and behavioral traits) of overweight and obese people | The aim of this study is to extensively phenotype subjects with varying degrees of obesity, as well as those with rare adipose disorders such as multiple symmetric lipomatosis (Madelung s disease), Dercums disease (adiposis dolorosa) and lipedema; to assess their hormonal, metabolic, cognitive and behavioral traits. | Two weeks |
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Obese subjects:
Overweight subjects:
Control subjects (may be matched for age, sex and years of education):
EXCLUSION CRITERIA:
Additional exclusion for lean control subjects:
The NIH Patient Recruitment and Public Liaison Office will receive inquiries from interested study subjects. Pre-screening by this office will exclude patients who require more than minimal assistance to complete activities of daily living in order to select subjects who can safely participate in the full phenotyping protocol. All others will be contacted by the protocol team to review exclusion criteria. Eligible patients will be invited to Clinical Research Center for a screening visit.
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men and women 18 years old and over with BMI > 30 BMI > 25 and < 30 BMI > 18.5 and < 25
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antoinette C Rabel, C.R.N.P. | Contact | (301) 451-8893 | rabela@mail.nih.gov | |
| Ranganath Muniyappa, M.D. | Contact | (301) 451-7702 | muniyapr@mail.nih.gov |
| Name | Affiliation | Role |
|---|---|---|
| Ranganath Muniyappa, M.D. | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Recruiting | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16926275 | Background | Adams KF, Schatzkin A, Harris TB, Kipnis V, Mouw T, Ballard-Barbash R, Hollenbeck A, Leitzmann MF. Overweight, obesity, and mortality in a large prospective cohort of persons 50 to 71 years old. N Engl J Med. 2006 Aug 24;355(8):763-78. doi: 10.1056/NEJMoa055643. Epub 2006 Aug 22. | |
| 12711737 | Background | Calle EE, Rodriguez C, Walker-Thurmond K, Thun MJ. Overweight, obesity, and mortality from cancer in a prospectively studied cohort of U.S. adults. N Engl J Med. 2003 Apr 24;348(17):1625-38. doi: 10.1056/NEJMoa021423. |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009767 | Obesity, Morbid |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| 12517229 | Background | Fontaine KR, Redden DT, Wang C, Westfall AO, Allison DB. Years of life lost due to obesity. JAMA. 2003 Jan 8;289(2):187-93. doi: 10.1001/jama.289.2.187. |
| 34677608 | Derived | Meral R, Malandrino N, Walter M, Neidert AH, Muniyappa R, Oral EA, Brown RJ. Endogenous Leptin Concentrations Poorly Predict Metreleptin Response in Patients With Partial Lipodystrophy. J Clin Endocrinol Metab. 2022 Mar 24;107(4):e1739-e1751. doi: 10.1210/clinem/dgab760. |
| 32382759 | Derived | Armiyaw L, Sarcone C, Fosam A, Muniyappa R. Increased beta-Cell Responsivity Independent of Insulin Sensitivity in Healthy African American Adults. J Clin Endocrinol Metab. 2020 Jul 1;105(7):e2429-38. doi: 10.1210/clinem/dgaa234. |
| 32052016 | Derived | Fosam A, Sikder S, Abel BS, Tella SH, Walter MF, Mari A, Muniyappa R. Reduced Insulin Clearance and Insulin-Degrading Enzyme Activity Contribute to Hyperinsulinemia in African Americans. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1835-46. doi: 10.1210/clinem/dgaa070. |
| 26900642 | Derived | Kassai A, Muniyappa R, Levenson AE, Walter MF, Abel BS, Ring M, Taylor SI, Biddinger SB, Skarulis MC, Gorden P, Brown RJ. Effect of Leptin Administration on Circulating Apolipoprotein CIII levels in Patients With Lipodystrophy. J Clin Endocrinol Metab. 2016 Apr;101(4):1790-7. doi: 10.1210/jc.2015-3891. Epub 2016 Feb 22. |
| 26020762 | Derived | Muniyappa R, Noureldin R, Ouwerkerk R, Liu EY, Madan R, Abel BS, Mullins K, Walter MF, Skarulis MC, Gharib AM. Myocardial Fat Accumulation Is Independent of Measures of Insulin Sensitivity. J Clin Endocrinol Metab. 2015 Aug;100(8):3060-8. doi: 10.1210/jc.2015-1139. Epub 2015 May 28. |
| 23530011 | Derived | Muniyappa R, Sable S, Ouwerkerk R, Mari A, Gharib AM, Walter M, Courville A, Hall G, Chen KY, Volkow ND, Kunos G, Huestis MA, Skarulis MC. Metabolic effects of chronic cannabis smoking. Diabetes Care. 2013 Aug;36(8):2415-22. doi: 10.2337/dc12-2303. Epub 2013 Mar 25. |
| 21367952 | Derived | Heikens MJ, Gorbach AM, Eden HS, Savastano DM, Chen KY, Skarulis MC, Yanovski JA. Core body temperature in obesity. Am J Clin Nutr. 2011 May;93(5):963-7. doi: 10.3945/ajcn.110.006270. Epub 2011 Mar 2. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |