MRI/MRE / Obesity / Metabolic Dysfunction Associated Steatotic Liver Disease · Interventional Study

Metabolic Flux Analysis in Metabolic Dysfunction-Associated Steatotic Liver Disease

ClinicalTrials.gov · August 12, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registry record for a planned prospective pilot study, not a report of results. The study will enroll approximately 20 adults with obesity and MASLD scheduled for bariatric surgery to measure changes in hepatic citric acid cycle flux and related metabolic parameters using stable isotope tracers, with assessments at baseline, surgery, and 6 months post-surgery. No outcome data are available in this record.

What was studied

Interventional, Single Group, Open label, Basic Science purpose. Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis, Obesity, Bariatric Surgery; age from 21 Years; to 70 Years. Intervention: Bariatric Surgery Participants Undergoing Metabolic Flux As…. n = 20. Vanderbilt University Medical Center (single center).

Key findings

Safety

This is a registry record with no posted results; no efficacy, safety, or outcome data are reported.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a planned pilot study with no results posted; it aims to characterize metabolic flux changes after bariatric surgery in MASLD but carries inherent limitations of small sample size and single-center design.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Change in hepatic citric acid cycle flux after bariatric surgery (assessed at Baseline/day of surgery to approximately 6 months post-surgery)

DesignInterventional, Single Group, Open label, Basic Science purpose

PopulationMetabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis, Obesity, Bariatric Surgery; age from 21 Years; to 70 Years

Sample size20

InterventionBariatric Surgery Participants Undergoing Metabolic Flux As…

SettingVanderbilt University Medical Center (single center)

Reported figures

Quoted from the source exactly as published.

Planned sample size20

Primary outcome measureChange in hepatic citric acid cycle flux after bariatric surgery, baseline/day of surgery to approximately 6 months post-surgery

Study phaseNot applicable (pilot)

Study recruitment statusNot yet recruiting

Caveats

This is a registry record with no posted results; no efficacy, safety, or outcome data are reported.
Small pilot sample (n=20) limits statistical power and generalizability.
Single-center design at academic medical center; findings may not generalize to other settings or populations.
No control or comparison arm; cannot attribute metabolic changes causally to surgery alone.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Prospective pilot design with planned serial assessments; no randomization or control arm.

Directness

moderate

Measures hepatic metabolic flux directly via stable isotope tracing; relates to liver pathology but uses surrogate biomarkers.

Consistency

insufficient

No results reported; consistency cannot be assessed from this registry record.

Risk of bias

limited

Single-center, uncontrolled design; no blinding mentioned. Selection bias possible in bariatric surgery cohort.

Sample adequacy

limited

Estimated enrollment 20 participants; small pilot sample, underpowered for definitive inference.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07760909). This is a study registration, not published results. Lead sponsor: Vanderbilt University Medical Center. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 20 participants (ESTIMATED). Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis, Obesity, Bariatric Surgery. Interventions: PROCEDURE: Bariatric surgery; OTHER: Stable isotope tracer infusion; DIAGNOSTIC_TEST: MRI/MRE; PROCEDURE: Research tissue collection during planned bariatric surgery. Primary outcome measures: Change in hepatic citric acid cycle flux after bariatric surgery , Baseline/day of surgery to approximately 6 months post-surgery. Brief summary: This prospective, single-center pilot study will evaluate metabolic flux dysregulation in adults with obesity and suspected or confirmed metabolic dysfunction-associated steatotic liver disease (MASLD) who are scheduled for protocol-eligible bariatric surgery at Vanderbilt University Medical Center. Participants will undergo research assessments before surgery, during the planned bariatric surgery encounter, and approximately 6 months after surgery. The study uses non-radioactive stable isotope tracer infusions, serial blood sampling, abdominal MRI/MRE, and research tissue specimens collected only during clinically planned bariatric surgery to quantify hepatic and extrahepatic metabolic fluxes. The primary objective is to determine how hepatic citric acid cycle flux and related metabolic pathways change after bariatric surgery and how these metabolic measures relate to liver fat, liver stiffness, and biopsy-graded MASLD/MASH severity.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

MRI/MREObesityMetabolic Dysfunction Associated Steatotic Liver DiseaseNCT07760909Stable isotope tracer infusionVanderbilt University Medical CenterBariatric surgeryResearch tissue collection during planned bariatric surgeryMetabolic Dysfunction Associated Steatohepatitis