No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 100
Sex
Any
Study type
Observational
Participants needed
2,000 (estimated)
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
Who this trial is looking for
This trial is looking for adults over 18 who are lean, overweight, or obese. Participants will undergo various tests to understand more about their physical and behavioral traits related to weight.
Are You a Good Fit for This Trial?
You may be able to join if
I am over 18 years old
I have a BMI over 30 if obese
I have a BMI over 25 and under 30 if overweight
I have a BMI over 18.5 and under 25 if normal weight
You may not be able to join if
I have significant physical limitations that prevent me from completing tests
I have current unstable medical conditions like heart or liver failure
I have any psychiatric condition that prevents my participation
I am unwilling or unable to give informed consent
I am pregnant
I have a history of obesity as an adolescent or adult if I am a lean control subject
I have current or past eating disorders like anorexia or bulimia if I am a lean control subject
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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Eligibility Criteria
* INCLUSION CRITERIA:
Obese subjects:
1. Obese men and women over the age of 18 years
2. BMI \> 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 wo…
* INCLUSION CRITERIA:
Obese subjects:
1. Obese men and women over the age of 18 years
2. BMI \> 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:
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 informed consent
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.
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