Clinical trial

Metabolic Flux Analysis in Metabolic Dysfunction-Associated Steatotic Liver Disease

Opening soon · Not applicable · 0 countries · Registry ID NCT07760909

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age21 Years to 70 Years
SexAll
Healthy volunteersNot accepted
ConditionMetabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis, Obesity, Bariatric Surgery

Full registry criteria

Inclusion Criteria: * Scheduled and clinically cleared for protocol-eligible bariatric surgery at Vanderbilt University Medical Center. * BMI ≥40 kg/m², or BMI \>35 kg/m² with at least one obesity-associated comorbidity, such as type 2 diabetes, cardiovascular disease, hypertension, hyperlipidemia, obstructive sleep apnea, MASLD, osteoarthritis, or polycystic ovarian syndrome. * Able and willing to complete study procedures, including informed consent, questionnaires, blood draws, MRI/MRE imaging, stable isotope tracer infusion, and research tissue collection during planned bariatric surgery. * Able to provide informed consent in English. Exclusion Criteria: * Contraindication to MRI/MRE, including implanted cardiac defibrillator, pacemaker, or other MRI-incompatible implanted device. * Prior gastric or intestinal surgery, pancreatic surgery, or other prior surgery that, in the judgment of the study team or bariatric surgeon, would interfere with study procedures or outcome interpretation. * Active cancer or ongoing cancer treatment. * Presence or history of HIV infection. * Alcohol use above study-defined limits: more than 14 alcoholic drinks per week for men or more than 7 alcoholic drinks per week for women, or illicit drug use that would interfere with safe participation or interpretation of study results. * Anemia or other hematologic condition that would increase risk from study blood collection. * Abnormal ECG or clinically significant cardiovascular finding that would increase risk from study procedures. * Impaired renal function or other clinically significant condition that would increase risk from study participation. * Known Wilson's disease, alpha-1 antitrypsin deficiency, hemochromatosis, or other non-MASLD chronic liver disease that would confound interpretation of study outcomes. * Any medical, surgical, or safety condition that, in the judgment of the PI, clinical co-investigator, CRC staff, anesthesia team, or bariatric surgeon, would make participation unsafe or interfere with completion of study procedures.

Treatments and study arms

Bariatric surgery

Procedure

Clinically indicated bariatric surgery, such as Roux-en-Y gastric bypass or sleeve gastrectomy, performed as part of standard clinical care.

Stable isotope tracer infusion

Other

Intravenous non-radioactive stable isotope tracers administered for research measurement of metabolic flux: \[¹³C₃\]lactate, \[6,6-²H₂\]-D-glucose, and \[9,9-²H₂\]palmitate.

MRI/MRE

Diagnostic Test

Abdominal MRI proton density fat fraction and magnetic resonance elastography to assess hepatic fat and stiffness before surgery and approximately 6 months after surgery.

Research tissue collection during planned bariatric surgery

Procedure

Liver, omentum, subcutaneous adipose tissue, and skeletal muscle specimens collected only during clinically planned bariatric surgery and only if safe in the surgeon's judgment.

Primary outcomes

Change in hepatic citric acid cycle flux after bariatric surgeryBaseline/day of surgery to approximately 6 months post-surgery

Change in hepatic citric acid cycle flux estimated from stable isotope enrichment patterns, including \[¹³C₃\]lactate-based measurements, before bariatric surgery and approximately 6 months after surgery.

Study locations

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No public site location was included in this record. Check the original registry for updates.