ObesityNCT00428987
Physical and Behavioral Traits of Overweight and Obese Adults
An observational study of Obesity and Healthy Volunteers, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Healthy Volunteers
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2007to not given
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: men and women 18 years old and over with BMI > 30 BMI > 25 and < 30 BMI > 18.5 and < 25
Who may be able to join
- Obese subjects:
- Obese men and women over the age of 18 years
- BMI > 30
- Overweight subjects:
- Overweight men and women over the age of 18 years
- BMI > 25 and < 30
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- Control subjects (may be matched for age, sex and years of education):
- Normal weight men and women over the age of 18 years
- BMI > 18.5 and < 25
Who cannot join
- Patients with significant physical limitations that may preclude them from completing the majority of the tests in this study
- Current unstable medical conditions including cardiac ischemia, severe respiratory insufficiency requiring oxygen therapy, hepatic or cardiac failure as assessed by history and physical exam
- Any psychiatric condition that would preclude participation in the study
- Patients unwilling or unable to give informed consent
- Pregnant woman.
- Additional exclusion for lean control subjects:
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- Previous history of obesity as an adolescent or adult
- Current or past history of eating disorders such as anorexia nervosa or bulimia
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Study of the Phenotype of Overweight and Obese Adults
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:
- Physical exam, electrocardiogram, blood and urine tests, instructions for recording food intake for 7 days
- Metabolic studies for menstruating women.
- Resting metabolic rate to study how many calories the body burns at rest.
- Mixed meal test to measure hormones such as insulin that regulate blood sugar.
- Glucose tolerance test to determine how sensitive the body is to insulin.
- 24-hour energy expenditure to measure the amount of oxygen breathed in and the amount of carbon dioxide breathed out.
- Repeat 24-hour energy expenditure.
- Diurnal blood sampling and temperature assessment to study the body s internal clock.
- Air-displacement plethysmography (Bod Pod) to measure body composition.
- Dual energy x-ray absortiometry (DEXA) to measure body fat and bone density.
- Repeat Bod Pod and DEXA.
- Anthropometric measurements and bioelectrical impedance to measure height, weight, and circumferences, skinfold thickness, fluid status and percentage body fat.
- Bromide dilution to measure the amount of water not in cells in the body.
- Doubly labeled water to measure the amount of calories burned in a 7-day period.
- 24-hour diet reports.
- Endothelial reactivity to measure how the blood vessels stretch or dilate for assessing cardiovascular health.
- Treadmill or bicycle exercise capacity test.
- Physical activity monitor.
- Unicorder to detect any breathing difficulties that may interfere with sleep.
- Fat and muscle biopsy to look for variations in gene expression in fat tissue and muscle.
- Neurocognitive testing to check memory, decision-making, hand-eye coordination, and reasoning.
- Evaluation of mood problems and assess personality type.
- Evaluation to assess the quantity and quality of pain experienced.
- Taste testing to determine the response to bitter, salty, sweet and sour substances.
- Occupational therapy evaluation to explore the subject's adaptations, if any, for performing personal, social or professional activities; the subject's views on his or her weight, body size and shape, and strategies to control weight.
Read the detailed description
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.
- Conditions
- Obesity, Healthy Volunteers
- Keywords
- Energy Expenditure, Body Composition, Obesity, Metabolism, Phenotype, Natural History, Morbid Obesity, Overweight, Healthy Volunteer
- Medical subject headings
- Obesity, Obesity, Morbid, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2007 (estimated)
- Study start8 Mar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ranganath Muniyappa, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428987
- Sponsor's protocol ID
- 070077
- Other IDs
- 07-DK-0077
- Status last verified
- 26 Aug 2026
- First submitted
- 27 Jan 2007
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 16926275Calle 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.
PubMed 12711737Fontaine 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.
PubMed 12517229Meral 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.
PubMed 34677608Armiyaw 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.
PubMed 32382759Fosam 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.
PubMed 32052016Kassai 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.
PubMed 26900642Muniyappa 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.
PubMed 26020762Muniyappa 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.
PubMed 23530011Heikens 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.
PubMed 21367952