Obesity Clinical Trial
Official title:
Predicting Adaptive Thermogenesis
Verified date | January 26, 2024 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will investigate how to better predict why some individuals gain or lose weight more easily than others. It will examine whether the increase in the amount of energy a body burns in 24 hours with overeating or the decrease over 24 hours with fasting can help determine how easily someone gains or loses weight. Healthy people between 18 and 60 years of age who have a body mass index (BMI) between 18.5 kg/m(2) and 24 kg/m(2) (for overfeeding study) or a BMI greater than 27 kg/m(2) with a body weight less than 350 pounds (weight loss study) may be eligible for this study. The study requires a 10-week admission to the NIH Clinical Center (2-week baseline, 6-week overfeeding/weight loss, 2-week post-weight change). Participants undergo the following tests and procedures during the hospital admission: - Medical history, physical examination and laboratory studies - Questionnaires to assess eating behavior, food preferences, body composition, and activity level - Body composition assessment (height, weight, waist circumference, and fat mass and muscle content through DXA and MRI scans) - Oral glucose tolerance test - Meal test to measure the response of certain hormones to food - Activity monitors to determine activity level - Metabolic chamber study to measure calories burned over 24 hours and monitor body temperature - Free-living energy use study to measure calories burned under normal home conditions over 7 days - Fat and muscle biopsies - Dietary intervention: Measurements of food intake and energy loss over a 6-week overfeeding (1.5 times the subject s normal food intake) or weight loss (one-half the subject s normal food intake) program Followup procedures after the inpatient stay: - Height and weight measurements at 6 months (overfeeding study participants) and monthly for the first year, at 3-month intervals for the second year, and then yearly for 3 more years (weight loss study participants) - Yearly visits (2-night inpatient stay) for all participants for repeat meal test, DXA, oral glucose tolerance test, behavioral questionnaires and, in women who can become pregnant, pregnancy test
Status | Completed |
Enrollment | 83 |
Est. completion date | March 20, 2023 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | - INCLUSION CRITERIA: - BMI greater than or equal to 27 kg/m(2) for the weight loss protocol but body weight less than 350 pounds to accommodate the DXA scanner. - BMI less than or equal to 24 kg/m(2) (and BMI greater than or equal to 18.5 kg/m(2) for the overfeeding protocols. A history of low BMI and difficulty gaining weight. - Age 18-60 years, to minimize potential co-morbid conditions which may indirectly affect EE. Minors under the age of 18 will be excluded because growth and pubertal issues are significant parameters that could affect our outcomes and also because the time requirements of the study are such that they would interfere with school schedules. Women who are post-menopausal will be excluded from the study as changes in their metabolism could affect the baseline measurements which are hypothesized to predict weight change. - Healthy, as determined by medical history, physical examination, and laboratory tests EXCLUSION CRITERIA: - Current smoking - Type 2 diabetes (according to the World Health Organization diagnostic criteria) - Impaired glucose tolerance (according to the World Health Organization diagnostic criteria) for those participating in the overfeeding study arms only - Endocrine disorders (Cushing s Disease, pituitary disorders, and hypo- and hyperthyroidism) - Chronic pulmonary disorders, including chronic obstructive pulmonary disease that would limit ability to follow the protocol (investigator judgment) and obstructive sleep apnea syndrome; only subjects with mild or exercise-induced asthma on no medications or on beta-adrenergic agonists only (such as albuterol) will be allowed to enter the study (provided use of these agents is not required for one week before study entry). - Cardiovascular diseases (coronary heart disease, heart failure, arrhythmias, and peripheral artery disease) - Hypertension (blood pressure measurement higher than 140/90 mm Hg (overfeeding study) or 160/95 (weight loss study) on two or more occasions or use of anti-hypertensive medications) - Diagnosed gastrointestinal diseases, including inflammatory bowel diseases (e.g., Crohn s disease and ulcerative colitis), malabsorption syndromes (e.g., celiac disease), gastric ulcer (active); only subjects with gastro-esophageal reflux will be allowed to enter the study - Presence of a pacemaker or other implantable devices/shrapnel which may interfere with the MRI or CorTemp measurements - Liver disease (cirrhosis, active hepatitis B or C, and AST or ALT greater than or equal to 1.5 times normal) - Renal disease (serum creatinine concentrations greater than or equal to 1.5 mg/dl and/or overt proteinuria) - Central nervous system disease (cerebrovascular accidents, dementia, and neurodegenerative disorders) - Cancer requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g., Stage 1 cervical cancer) - Alcohol (more than 3 drinks per day) and/or drug abuse (such as amphetamines, cocaine, heroin, or marijuana) - Current or past history of: bipolar disorder, schizophrenia or presence of psychotic symptoms, bulimia nervosa or anorexia nervosa, or current major depressive disorder - Pregnancy or lactation - Taking weight loss medications - Weight change of plus or minus 5% in the last 3 months Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators. Additionally, potential subjects might be excluded if they demonstrate a style of interpersonal relationships that would inhibit successful completion of the study. |
Country | Name | City | State |
---|---|---|---|
United States | NIDDK, Phoenix | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Adams M, Montague CT, Prins JB, Holder JC, Smith SA, Sanders L, Digby JE, Sewter CP, Lazar MA, Chatterjee VK, O'Rahilly S. Activators of peroxisome proliferator-activated receptor gamma have depot-specific effects on human preadipocyte differentiation. J Clin Invest. 1997 Dec 15;100(12):3149-53. doi: 10.1172/JCI119870. — View Citation
Allison DB, Heshka S, Sepulveda D, Heymsfield SB. Counting calories--caveat emptor. JAMA. 1993 Sep 22-29;270(12):1454-6. doi: 10.1001/jama.270.12.1454. — View Citation
Astrup A, Buemann B, Christensen NJ, Madsen J, Gluud C, Bennett P, Svenstrup B. The contribution of body composition, substrates, and hormones to the variability in energy expenditure and substrate utilization in premenopausal women. J Clin Endocrinol Metab. 1992 Feb;74(2):279-86. doi: 10.1210/jcem.74.2.1530952. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary goal of the current study is to determine if changes in energy expenditure in response to acute over- and underfeeding are related to variation in changes in weight and body energy stores with longer-term over- and underfeeding. | Changes in energy expenditure, weight, and body energy stores measured via physical examinations, laboratory studies, questionnaires, body composition assessments, oral glucose tolerance tests, metabolic chamber studies, and free-living energy use studies | Ongoing | |
Secondary | Determine if hormones, responses to behavioral testing, adipocyte size, body composition, core temperature, spontaneous activity, and food absorption/excretion are related to changes in EE with over/under-feeding and variation in weight change. | Changes in hormones, behavior, adipocyte size, body composition, core temperature, spontaneous activity, food absorption/excretion, changes in EE, and weight measured via physical examinations, laboratory studies, questionnaires, body composition assessments, oral glucose tolerance tests, meal tests, activity monitors, metabolic chamber studies, free-living energy use studies, and fat and muscle biopsies | Ongoing |
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