ClinicalTrials.gg
RecruitingNCT00428987Updated Sep 28, 2026

Physical and Behavioral Traits of Overweight and Obese Adults

An observational study in Obesity and Healthy Volunteers, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Observational

From the registry’s dates

  • Started Mar 2007; still recruiting 19 years 8 months later.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
2,000
Ages
18 Years to 100 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 104 studies in Obesity by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) — 12 open to participants now, 13 under way, none of them phase 3. Obesity · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Planned enrollment
3rd of 31
2,000 · median 144
Started
2007
with 6 others
Observational
31 of 104
6 open now
Registered
52nd of 104
by date

Among the 104 studies in Obesity by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), this one is the 3rd largest by planned enrollment of the 31 observational ones that give a count, is one of 7 that started in 2007, is one of 31 observational ones, and was the 52nd registered.

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

Browse Obesity studies →

Open to participants now

12 of the 104 studies in Obesity by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) are open now, in 1 country. Recruiting first, the newest first:

6 more — sign in →

By country, each count listing its studies:

All 12 open studies →

Where they have run

Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.

This study: 18 Years to 100 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 104 studies in Obesity by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Obesity
  • Healthy Volunteers

Keywords

  • Energy Expenditure
  • Body Composition
  • Obesity
  • Metabolism
  • Phenotype
  • Natural History
  • Morbid Obesity
  • Overweight
  • Healthy Volunteer
04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

men and women 18 years old and over with BMI > 30 BMI > 25 and \< 30 BMI > 18.5 and \< 25

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Obese subjects:

  1. Obese men and women over the age of 18 years
  2. > 30

Overweight subjects:

  1. Overweight men and women over the age of 18 years
  2. BMI > 25 and \< 30

Control subjects (may be matched for age, sex and years of education):

  1. Normal weight men and women over the age of 18 years
  2. BMI > 18.5 and \< 25

Exclusion criteria

EXCLUSION CRITERIA:

  1. Patients with significant physical limitations that may preclude them from completing the majority of the tests in this study
  2. Current unstable medical conditions including cardiac ischemia, severe respiratory insufficiency requiring oxygen therapy, hepatic or cardiac failure as assessed by history and physical exam
  3. Any psychiatric condition that would preclude participation in the study
  4. Patients unwilling or unable to give
  5. Pregnant woman.

Additional exclusion for lean control subjects:

  1. Previous history of obesity as an adolescent or adult
  2. 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.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
2,000 participants (estimated)

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Two weeks

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
    • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Contactccopr@nih.gov · 800-411-1222
08

References and documents

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 16926275 ↗
  • 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. PubMed 12711737 ↗
  • 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. PubMed 12517229 ↗
  • 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. PubMed 34677608 ↗
  • 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. PubMed 32382759 ↗
  • 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. PubMed 32052016 ↗
  • 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. PubMed 26900642 ↗
  • 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. PubMed 26020762 ↗
  • 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. PubMed 23530011 ↗
  • 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. PubMed 21367952 ↗
09

Timeline

Tracking since Sep 25, 2026

Started Mar 2007 (actual).

How these figures are worked out, and which studies are left out of them.

Registered
Jan 27, 2007
First posted
Jan 30, 2007
StartActual
Mar 8, 2007
Last update
Sep 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00428987
Responsible party
Sponsor
First posted
Jan 30, 2007
Start date
Mar 8, 2007
Last update
Sep 28, 2026

Study contacts

Antoinette C Rabel, C.R.N.P.
Contact
rabela@mail.nih.gov
(301) 451-8893
Ranganath Muniyappa, M.D.
Contact
muniyapr@mail.nih.gov
(301) 451-7702
Ranganath Muniyappa, M.D.
principal investigator · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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