Effect of Acetyl-L-carnitine on Chronic Pancreatitis

Status Terminated

Clinical Trial Summary

An open label pilot study will determine the effect of the amino acid nutritional supplement acetyl-L-carnitine (ALC) on pain, quality of life, well-being, and serum pro-inflammatory mediator and oxidative stress levels in volunteers with chronic pancreatitis. The ALC is given to all participants for 3 months, and assessments will occur at intake and after 3 months.

Clinical Trial Description

This is an open label pilot study to determine the effect of the amino acid nutritional supplement acetyl-L-carnitine (ALC) on chronic pancreatitis. ALC is an acetylated form of naturally occurring amino acid L-carnitine ((R)-3-Acetyloxy-4-trimethylammonio-butanoate) found in red meat and is readily commercially available. Supplementation with ALC may decrease pain and improve overall health based on our preclinical treatment studies in rats with high fat and alcohol induced pancreatitis. In rats, ALC reduces pain measures, improves glucose tolerance, decreases lipid peroxidation, and Ki67 cellular injury biomarker, and improves pancreatic histopathology. The measurable outcomes of this clinical study are patients' questionnaire scores for:

pain, quality of life, well-being, and serum pro-inflammatory mediator and oxidative stress levels in volunteers with chronic pancreatitis. The questionnaires are given at intake and at experiment end (3 months). Participants will receive ALC for 3 months. These findings will indirectly determine the effect of ALC on the function and inflammatory state of the pancreas. Currently, there is no specific therapy for chronic pancreatitis, and its pathophysiology is still poorly understood. It is known that chronic pancreatitis is caused by ongoing inflammation in the pancreas, yet, no pharmacological intervention exists that optimally addresses this. The broad actions of ALC as an antioxidant and anti-inflammatory agent as well as its ability to reduce side-effects of alcohol cessation make it a perfect compound to pursue for the treatment of pancreatitis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02538146
Study type	Interventional
Source	University of Kentucky
Contact
Status	Terminated
Phase	Early Phase 1
Start date	August 2015
Completion date	October 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03112759` - Assessing the Utility of Cognitive Behavioral Therapy for Pain Control in Patients With Chronic Pancreatitis	N/A
Enrolling by invitation	`NCT05410795` - Establishment and Verification of Pancreatic Volume Formula Based on Imaging
Active, not recruiting	`NCT02965898` - The Effect of Vitamin D Substitution on the Development of Chronic Pancreatitis	N/A
Completed	`NCT01452217` - Non-invasive MRI to Quantify the Effect of Secretin on Pancreatic Blood Flow and Perfusion in Healthy Volunteers	Phase 1
Completed	`NCT02868047` - Establishing Standards for Normal Pancreatic EUS	N/A
Completed	`NCT00685087` - A Prospective Study of Natural History of Pancreatitis	N/A
Completed	`NCT04949828` - Effect of CREON on Exocrine Pancreatic Insufficiency (EPI) Symptoms
Recruiting	`NCT06068426` - Incorporating Endoscopic Ultrasound and Elastography Towards Improving Outcomes of Pediatric Pancreatitis Management	N/A
Active, not recruiting	`NCT05042284` - Effect of Non-enteric Coated Enzymes Substitution on Pain in Patients With Chronic Pancreatitis	N/A
Active, not recruiting	`NCT05764629` - An Observational Study on Post-chronic Pancreatitis Diabetes Mellitus
Completed	`NCT03850977` - Is There an Association Between Chronic Pancreatitis and Pulmonary Function
Recruiting	`NCT05692596` - The Pancreas Interception Center (PIC) for Early Detection, Prevention, and Novel Therapeutics
Recruiting	`NCT06015945` - Role of Home-based Transcutaneous Electrical Acustimulation for Treatment of Pain in Patients With Chronic Pancreatitis	N/A
Completed	`NCT04619511` - Risk Factors for Post-ESWL and Post-ERCP Pancreatitis
Completed	`NCT03283566` - Hydroxychloroquine and Metabolic Outcomes in Patients Undergoing TPAIT	Phase 2
Recruiting	`NCT03434392` - QST Study: Predicting Treatment Response in Chronic Pancreatitis Using Quantitative Sensory Testing	N/A
Completed	`NCT01430234` - Enzyme Suppletion in Exocrine Pancreatic Dysfunction	Phase 4
Completed	`NCT01318369` - Efficacy Study of Δ9-THC to Treat Chronic Abdominal Pain	Phase 2
Terminated	`NCT01442454` - Endoscopic Ultrasound (EUS) Features of Chronic Pancreatitis	N/A
Completed	`NCT00755573` - Pain and Chronic Pancreatitis - Clinical End Experimental Studies	Phase 2/Phase 3