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NCT07613255Not yet recruiting

Evaluating Metabolic Health in Individuals With Extreme Obesity

Evaluating Energy Metabolism and Metabolic Health in Individuals With Extreme Obesity

Source: ClinicalTrials.gov · Last updated 17 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
10 (estimated)
First submitted
13 May 2026
Start date
1 Oct 2026
Primary completion date
1 Mar 2027
Lead sponsor
Pennington Biomedical Research Center
Diseases
Obesity
NCT number
NCT07613255

What you commit to

  • Study type: Observational
  • Planned participants: 10
  • From 1 Oct 2026 to the primary completion date, 1 Mar 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Individuals with untreated thyroid disease
  • Individuals with untreated or poorly controlled binge eating disorder, bulimia, substance abuse or dependence, mania, and psychosis.
  • 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.

Lab values

  • 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

Other

  • Women who are pregnant, trying to become pregnant, or currently breastfeeding.
  • Being unwilling to comply with the study procedures.
  • Not willing to have biospecimens and/or images stored for future research use.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.