Status:
COMPLETED
Energy Metabolism and Nutrient Absorption in Lean and Obese Individuals
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Eligibility:
MALE
18-45 years
Brief Summary
This study will examine whether there are differences in energy (calories) losses in stool and urine between lean and obese people. People gain weight when the amount of calories in the food they eat ...
Detailed Description
The prevalence of obesity has risen to epidemic proportions in the world, resulting from both excessive energy intake and low levels of energy expenditure. The effect of nutrient absorption on energy ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Free of acute and chronic diseases (especially GI disorders) as determined by medical history, physical examination and laboratory tests.
- Individuals may be taking antacids and/or laxative drugs but they must be discontinued 3 or more weeks before admission.
- Age 18-45 years (in order to minimize the effect of aging on nutrient absorption).
- BMI 18-25 kg/m(2) or greater than 35 kg/m(2).
- EXCLUSION CRITERIA:
- History or clinical manifestation of:
- Current smoking
- Type 2 diabetes (according to the World Health Organization diagnostic criteria)
- Endocrine disorders, such as Cushing's disease, pituitary disorders, and hypo- and hyperthyroidism
- HIV infection (self-report), due to effects on weight and body composition of HIV and medications used to treat HIV
- Active tuberculosis (self-report)
- Pulmonary disorders, including physician diagnosed chronic obstructive pulmonary diseases 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
- Cardiovascular diseases, including coronary heart disease, heart failure, arrhythmias, and peripheral artery disease
- Hypertension (according to the World Health Organization diagnostic criteria), treated or uncontrolled
- Gastrointestinal disease, including inflammatory bowel diseases (e.g. Crohn's disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease), gastric ulcer (active)
- Lactose intolerance
- Liver disease, including non-alcoholic fatty liver disease, AST or ALT greater than 1.5 x normal value, cirrhosis, active hepatitis B or C
- Renal disease, as defined by serum creatinine concentrations greater than 1.5 mg/dl and/or overt proteinuria
- Central nervous system disease, including previous history of 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
- Behavioral or psychiatric conditions that would be incompatible with a safe and successful participation in the study (such as major depression, schizophrenia and presence of psychotic symptoms)
- Taking weight loss drugs
- Use of any antibiotic or probiotic agents within the 2 months prior to the study
- Evidence of alcohol and/or drug abuse (more than 3 drinks per day and use of drugs, such as amphetamines, cocaine, heroin, or marijuana)
Exclusion
Key Trial Info
Start Date :
December 15 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 19 2013
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00414063
Start Date
December 15 2006
End Date
March 19 2013
Last Update
December 17 2019
Active Locations (1)
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1
NIDDK, Phoenix
Phoenix, Arizona, United States, 85014