Cholesterol and Fatty Acid Synthesis in Islet and Liver Transplant Patients and Effect of Dietary Intervention

Phase 1

Completed

• Conditions: Immunosuppression; Hyperlipidemias; Diabetes Mellitus, Type 1
• Interventions: Dietary Supplement: Dietary intervention - supplements

• Registration Number: NCT00947635
• Lead Sponsor: University of Alberta

Brief Summary

The purpose is to investigate possible mechanisms of increased blood lipid levels following transplantation, and also to see if a comprehensive dietary intervention is effective in reducing blood lipid levels in post-transplant patients.

Detailed Description

Post-transplantation patients frequently have an increase in blood lipid levels presumed to be due to immunosuppressive agents, however it is currently unknown the mechanisms by which this occurs. Dietary interventions have frequently been unsuccessful in these patients, which may be due to single-nutrient interventions and lack of support and guidance. This research will use stable isotope methods to estimate cholesterol and fatty acid synthesis to determine if these pathways are affected by immunosuppression in patients before and after islet and liver transplant. In addition, it will be determined if a multi-nutrient dietary intervention will be implemented post-transplant can reduce blood lipid levels in to prevent further polypharmacy these patients.

Study Timeline

• Study Start: 2005-11
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2009-07
• Study First Submitted: 2009-07-22
• Study First Submitted QC: 2009-07-24
• Last Update Submitted: 2009-07-24
• Study First Posted: 2009-07-28
• Last Update Posted: 2009-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• on islet or liver transplant list
• post-transplant >3 months
• physically able to participate in study and intervention

Exclusion Criteria

• < 18 years of age
• family history of premature cardiovascular disease or familial hyperlipidemia (control subjects)
• cholestatic diseases (liver transplant patients)
• type 2 diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Islet transplant	Dietary intervention - supplements	People with Type 1 diabetes undergoing islet transplantation
Liver transplant	Dietary intervention - supplements	People with liver failure undergoing liver transplantation
Control	Dietary intervention - supplements	Healthy normal people which serve as control group

Primary Outcome Measures

Name	Time	Method
Cholesterol and fatty acid synthesis	Pre-transplant, post-transplant (>3 months after transplant, up to 2 years) and post-dietary intervention (1 month after post-transplant measurement)

Secondary Outcome Measures

Name	Time	Method
Blood lipid levels	Pre-transplant, post-transplant (>3 months after transplant, up to 2 years) and post-dietary intervention (1 month after post-transplant measurement)

Trial Locations

Locations (1)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada