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Evaluating Metabolic Health in Individuals With Extreme Obesity

StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later Jul 1, 2026 → Mar 1, 2027
See other at-risk trials from Pennington Biomedical Research Center

Record History

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  1. Primary completion pushed from Jul 1, 2026 to Mar 1, 2027 Show 5 more changesShow less
    • Start date: Jul 1, 2026 to Oct 1, 2026
    • Study completion pushed from Aug 1, 2026 to Apr 1, 2027
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Publications: details revised at 6 of 6 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07613255
Lead Sponsor Pennington Biomedical Research Center
Conditions
(from sponsor)		 BMI>40
Related terms Obesity, Morbid
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov