The Role of Hepatic Denervation in the Dysregulation of Glucose Metabolism in Liver Transplant Recipients

• Status: Suspended
• Trial end date: 2027-04-30
• Target enrollment: 0
• Participant gender: All

Summary

It is believed that important brain centers send signals through the vagus nerve to the liver to suppress the amount of glucose (sugar) that gets produced. People who have received liver transplants have had their vagus nerve cut during transplantation, and many of these individuals have diabetes at one year post-transplant. The goals of this study are: to see whether metabolic control centers in the brain can still be activated normally with the medication diazoxide in patients who have had a liver transplant, and to understand whether disrupting the vagus nerve would result in excess glucose being produced by the liver (ie. a potential mechanism for why these patients develop diabetes).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Albert Einstein College of Medicine; Albert Einstein College of Medicine, Inc.
• Treatments: Diazoxide; Niacin; Niacinamide; Nicotinic Acids

Criteria

Inclusion Criteria:

• Liver Transplant at least one year ago

• Age: 21-70

Exclusion Criteria:

• BP > 150/90 or <90/60 on more than one occasion, unless there is a documented history of white coat hypertension by treating physician.

• Triglycerides > 400 mg/dl and/or Total Cholesterol >300 mg/dl

• Clinically significant liver dysfunction

• Clinically significant kidney dysfunction, GFR: <60 mg/dL

• Anemia: HgB <12.5 for men and <11.0 for women

• Positive urine drug test. Occasional use of cannabis (once or twice per week) will not be a basis for exclusion.

• Urinalysis: Clinically significant abnormalities

• Clinically significant electrolyte abnormalities

• Smoking >10 cig/day

• Alcohol: Men >14 drinks/wk or >4 drinks/day, Women >7 drinks/wk or >3 drinks/day

• History of active hepatitis infection, HIV/AIDS, chronic kidney disease (stage 3 or greater), active cancer, cardiovascular disease or other heart disease, systemic rheumatologic conditions, seizures, bleeding disorders, muscle disease

• Surgeries that involve removal of endocrine glands except for thyroidectomy (if euthyroid on thyroid hormone replacement - if such history T4 and TSH will be checked)

• Pregnant women

• Subject enrolled in another study less than one month prior to the anticipated start date in the proposed study, besides those done by our group

• Family history: family history of premature cardiac death

• Allergies to medication administered during study

• Uncontrolled psychiatric disorders

• Any condition which in the opinion of the PI makes the subject ill-suited for participation in the study