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NCT03997422 · ClinicalTrials.gov registry record · NA
Hepatic Energy Fluxes in NASH and NAS Patients
A NA study of Weight Loss and Overweight or Obesity, sponsored by University of Minnesota.
- Active
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT03997422: Active NA study of Weight Loss and Overweight or Obesity, sponsored by University of Minnesota.
NCT03997422 is a NA study of Weight Loss and Overweight or Obesity that is active but no longer recruiting, run by University of Minnesota. The registered enrollment target is 30 participants, below the 1,501-participant average among 116 other Weight Loss trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03997422, a NA study of Weight Loss and Overweight or Obesity, is active but no longer recruiting, sponsored by University of Minnesota.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
Diseases along the nonalcoholic fatty liver disease spectrum, which are tightly coupled to the obesity epidemic, are soon to become the commonest indication for liver transplantation in the United States. Bariatric surgery shows great promise in the treatment of these diseases. The studies proposed herein will be the first to measure in humans the relationships among (i) the liver's ability to burn fat and make glucose, two of its primary functions; (ii) the severity of nonalcoholic fatty liver disease; and (iii) the responses to bariatric surgery. These experiments will support deeper future mechanistic investigations of the metabolic mechanisms underlying nonalcoholic steatohepatitis (NASH) improvement with bariatric surgery. The premise of this study is that deranged hepatic mitochondrial metabolism is a key biomarker and mediator of the nonalcoholic fatty liver disease (NAFLD)/NASH continuum, and the central hypothesis the investigators will test is that preoperative hepatic fat oxidation and glucose production flux parameters differ between low versus high NAFLD activity score (NAS), and response of the liver to bariatric surgery can be predicted by preoperative fluxes.
Primary Outcome
Non-invasive dual isotope tracer-coupled magnetic resonance spectroscopy (MRS) will be used to measure tricarboxylic acid cycle (TCA) flux, anaplerosis, and gluconeogenesis. Outcome reported in micromols per minute per kg of lean body mass.
Conditions Studied
Interventions
- PROCEDURE Vertical Sleeve Gastrectomy (VSG)
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-07-01 |
| Est. Completion | 2026-05-31 |
| Phase | NA |
What the registry record for NCT03997422 still lists
NCT03997422 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,501-participant average among 116 other Weight Loss trials with a reported enrollment target (98% lower).
The record links to 5 conditions, with Weight Loss appearing as the primary indexed condition, and to 1 intervention - of which Vertical Sleeve Gastrectomy (VSG) is the first listed.
NCT03997422 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT03997422 about?
NCT03997422 is a clinical study titled "Hepatic Energy Fluxes in NASH and NAS Patients". Diseases along the nonalcoholic fatty liver disease spectrum, which are tightly coupled to the obesity epidemic, are soon to become the commonest indication for liver transplantation in the United States. Bariatric surgery shows great promise in the treatment of these diseases. The studies proposed ...
What is the current status of trial NCT03997422?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2019-07-01. Estimated completion is 2026-05-31.
What conditions does trial NCT03997422 study?
This clinical trial studies the following conditions: Weight Loss, Overweight or Obesity, Bariatric Surgery Candidate, NASH - Nonalcoholic Steatohepatitis, NAS.
What interventions are being tested in trial NCT03997422?
The interventions under investigation include: Vertical Sleeve Gastrectomy (VSG) (PROCEDURE).
Who is sponsoring clinical trial NCT03997422?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03997422 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03997422's enrollment target sits among peer trials
30 100th of 116 higher than 14 of 116 other Weight Loss trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Weight Loss trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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