Cholic Acid for Hepatic Steatosis in Lipodystrophy

Status Completed

Clinical Trial Summary

To evaluate the efficacy and safety of cholic acid therapy in treating lipodystrophy patients with hepatic steatosis. This is a randomized, double-blind, placebo-controlled cross-over study.

Clinical Trial Description

Lipodystrophies are rare disorders characterized by selective loss of adipose tissue and predisposition to develop insulin resistance and its associated metabolic complications such as dyslipidemia, diabetes mellitus and hepatic steatosis. Nonalcoholic hepatic steatosis or steatohepatitis caused by excessive accumulation of triglycerides in hepatocytes, in fact, is a common feature of these disorders. Often a cause for significant morbidity and even mortality in lipodystrophic patients, hepatic steatosis poses a significant therapeutic challenge. Recent insight into the role of primary bile acids, cholic acid and chenodeoxycholic acid, which are endogenous ligands for the farnesoid X receptor (FXR), in regulating hepatic triglyceride homeostasis offers new treatment options for hepatic steatosis. Cholic acid was shown to inhibit hepatic triglyceride accumulation by more than 50% in a mouse model of hepatic steatosis and hypertriglyceridemia. Cholic acid has been previously used to treat inborn errors of bile acid synthesis in children without any side effects. In other studies in adults, cholic acid has been reported to be well tolerated. Therefore, we propose to investigate a potentially safe therapeutic option for its efficacy in reducing hepatic steatosis in patients with lipodystrophies. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00457639
Study type	Interventional
Source	University of Texas Southwestern Medical Center
Contact
Status	Completed
Phase	Phase 2
Start date	April 2006
Completion date	April 2011

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05480696` - Soluble Fibre Supplementation in NAFLD	Phase 1
Completed	`NCT05124847` - TREating Pediatric Obesity	N/A
Recruiting	`NCT05499585` - Treating Pediatric NAFLD With Nutrition	N/A
Completed	`NCT03717935` - Oral Amino Acid Nutrition to Improve Glucose Excursions in PCOS	N/A
Active, not recruiting	`NCT02493153` - Hepatic Steatosis After Cholecystectomy	N/A
Active, not recruiting	`NCT05654051` - The SLIM LIVER Study	Phase 2
Completed	`NCT03334214` - Safety, Tolerability, and Pharmacodynamics of IONIS-DGAT2Rx in Adult Patients With Type 2 Diabetes	Phase 2
Recruiting	`NCT05599945` - First Human Dose Trial for a New Medication to Potentially Treat Liver Diseases	Phase 1
Enrolling by invitation	`NCT02816814` - Lacto-ovo-vegetarian Diet Riched in Omega-3 Fatty Acids in Menopausal Women	N/A
Active, not recruiting	`NCT03587727` - Hepatic Mitochondrial Function in Youth
Not yet recruiting	`NCT05935826` - Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)	N/A
Not yet recruiting	`NCT06394206` - Benefit of a Hospital Intervention in Patients With Hepatic Steatosis	N/A
Not yet recruiting	`NCT06363617` - Implementation of the Fatty Liver Index in Primary Care	N/A
Recruiting	`NCT03142698` - Evaluation of 4 MRI Methods (PDFF 3, 6 and 11 Gradient Echoes and Spectroscopy) Compared to the Reference Method (Liver Biopsy) in Quantification of Hepatic Steatosis	N/A
Completed	`NCT00480922` - Effects of a Low Glycemic Load Diet on Fatty Liver in Children	N/A
Not yet recruiting	`NCT05871749` - Effects of Hepatic Fibrosis on Hepatic Steatosis Using the Ultrasound Attenuation Imaging in Chronic Hepatitis B
Recruiting	`NCT05897073` - Time-Restricted Eating, Exercise and Cardiometabolic Health in Obesity	N/A
Completed	`NCT03961516` - Glycemic Characterization and Pancreatic Imaging Correlates in Cystic Fibrosis
Completed	`NCT04180631` - Quantitative US for Hepatic Steatosis	N/A
Terminated	`NCT00845845` - Fish Oil and Diet for the Treatment of Non-Alcoholic Steatohepatitis (NASH)	Phase 2