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NCT07613255
Evaluating Metabolic Health in Individuals With Extreme Obesity
Conditions: BMI>40
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: Yes
Enrollment: 10
Sponsor: Pennington Biomedical Research Center
Summary
This research will evaluate energy metabolism (expenditure and fat oxidation), metabolic flexibility (response to a high-fat test meal) in 10 individuals with a BMI ≥60 kgm2 using gold-standard assessments of energy metabolism, metabolic flexibility, and body composition. Males and females (18-80 y) with extreme obesity (BMI: ≥60 kg/m2) will be recruited from Baton Rouge, Louisiana. Exclusion criteria include major organ failure, uncontrolled endocrine disease, severe psychiatric illness, pregnancy, and inability to comply with study procedures. The total duration of participation for each individual is estimated at approximately 10 days. If qualified, participants (BMI≥60 kg/m2; n=10) will complete one outpatient visit and one inpatient visit with 36hr metabolic chamber testing.
Eligibility Criteria
Inclusion Criteria:
* Healthy male or female
* Between 18 - 80 years of age
* BMI ≥60 kg/m2
* Willing to consume pre-prepared meals
* Willing to comply with the study procedures.
* Willing to have biospecimens and images stored for future use.
Exclusion Criteria:
* Diabetic individuals with complications such as:
* Diabetic eye disease requiring laser treatment
* Diabetic nerve disease associated with foot ulcers or amputations
* Diabetic vascular disease associated with gangrene or amputation
* Diabetic kidney disease accompanied by a creatinine greater than 2.0 mg/dL
* Individuals with prior gastrointestinal surgery except appendectomy or cholecystectomy
* Individuals with untreated thyroid disease
* Individuals with untreated or poorly controlled binge eating disorder, bulimia, substance abuse or dependence, mania, and psychosis.
* Women who are pregnant, trying to become pregnant, or currently breastfeeding.
* Individuals with major organ system failure like cirrhosis, hepatic insufficiency, portal hypertension, severe renal insufficiency or on dialysis, severe arterial insufficiency, dementia or the inability to give an informed consent.
* Being unwilling to comply with the study procedures.
* Not willing to have biospecimens and/or images stored for future research use.
Source: ClinicalTrials.gov (NCT07613255). StuddyBuddy aggregates publicly available trial information.