RECRUITING

Physical and Behavioral Traits of Overweight and Obese Adults

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Study of the Phenotype of Overweight and Obese Adults

Quick Facts

Study Start:2007-03-08
Study Completion:N/A
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT00428987

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Obese men and women over the age of 18 years;
  2. 2. BMI greater than 30;
  3. 1. Overweight men and women over the age of 18 years;
  4. 2. BMI greater than 25 and less than 30
  5. 1. Normal weight men and women over the age of 18 years;
  6. 2. BMI greater than 18.5 and less than 25
  1. 1. Patients with significant physical limitations that may preclude them from completing the majority of the tests in this study.
  2. 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. 3. Any psychiatric condition that would preclude participation in the study;
  4. 4. Patients unwilling or unable to give informed consent.
  5. 5. Pregnant women
  6. 1. Previous history of obesity as an adolescent or adult;
  7. 2. Current or past history of eating disorders such as anorexia nervosa or bulimia.
  8. 1. Dependence on drugs other than nicotine, caffeine and cannabis, within the past 6 months
  9. 2. Any history of intravenous illegal drug use
  10. 3. Alcohol use of more than 5 drinks per day, on 3 or more days in a week; or more than 15 drinks per week
  11. 4. History of hepatitis B or C or current hepatitis A, B or C, or other liver disease associated with steatosis
  12. 5. HIV
  13. 6. History of diabetes (type 1 or type 2) or polycystic ovary disease or other conditions that may confound our study results
  14. 7. Professional or collegiate athletes or participation in more than 60 minutes per day of vigorous exercise
  15. 8. Use of prescribed or over the counter or herbal/alternative medications/ preparations with effects on glucose and lipid metabolism other than oral contraceptives
  16. 9. Pregnancy or lactation
  17. 10. Any condition or physical attribute which would interfere with MRI study e.g. claustrophobia, cochlear implant, metal fragments in the eye, certain types of tattoos or other metal implanted in the body

Contacts and Locations

Study Contact

Antoinette C Rabel, C.R.N.P.
CONTACT
(301) 451-8893
rabela@mail.nih.gov
Ranganath Muniyappa, M.D.
CONTACT
(301) 451-7702
muniyapr@mail.nih.gov

Principal Investigator

Ranganath Muniyappa, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

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

  • Ranganath Muniyappa, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2007-03-08
Study Completion DateN/A

Study Record Updates

Study Start Date2007-03-08
Study Completion DateN/A

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Obesity
  • Healthy Volunteers