Physical and Behavioral Traits of Overweight and Obese Adults
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|ClinicalTrials.gov Identifier: NCT00428987|
Recruitment Status : Recruiting
First Posted : January 30, 2007
Last Update Posted : March 20, 2020
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.
|Condition or disease|
|Obesity Healthy Volunteers|
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 the majority of 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.
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|Official Title:||Study of the Phenotype of Overweight and Obese Adults|
|Actual Study Start Date :||March 8, 2007|
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 men and women over the age of 18 years with BMI greater than 30, who are reasonably healthy
Overweight men and women over the age of 18 years with BMI greater than 25 and less than 30, who are reasonably healthy
- Phenotype (physical and behavioral traits) of overweight and obese people [ Time Frame: Two weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00428987
|Contact: Antoinette C Rabel, C.R.N.P.||(301) email@example.com|
|Contact: Ranganath Muniyappa, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Ranganath Muniyappa, M.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|