Protocol Number: 07-DK-0077

Title:

Study of the Phenotype of Overweight and Obese Adults

Number:

07-DK-0077

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.

Sponsoring Institute:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

Obese subjects:

1. Obese men and women over the age of 18 years;

2. BMI greater than 30;

Overweight subjects:

1. Overweight men and women over the age of 18 years;

2. BMI greater than 25 and less than 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 greater than 18.5 and less than 25

EXCLUSION CRITERIA:

1. Patients over 450 lbs;

2. Patients with significant physical limitations that may preclude them from completing the majority of the tests in this study.

3. Current, unstable medical conditions including cardiac ischemia; severe respiratory insufficiency requiring oxygen therapy; hepatic or cardiac failure as assessed by history and physical exam;

4. Any psychiatric condition that would preclude participation in the study;

5. Patients unwilling or unable to give informed consent.

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.

Special Instructions:

Currently Not Provided

Keywords:

Body Composition

Energy Expenditure

Physical Activity

Neurocognitive Function

Behavior

Recruitment Keyword(s):

Body Composition

Morbid Obesity

Overweight

Healthy Volunteer

Condition(s):

Morbid Obesity

Diabetes Mellitus Type 2

Insulin Resistance

Obstructive Sleep Apnea

Mood Disorders

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Diabetes and Digestive and Kidney Diseases

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

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.

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.

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.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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