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

University of Alberta

Status and phase: Completed; Phase 2; Phase 1

Conditions: Diabetes Mellitus, Type 1; Hyperlipidemias; Immunosuppression

Treatments: Dietary Supplement: Dietary intervention - supplements

Study type: Interventional

Funder types: Other

Identifiers

NCT00947635

Islet-Liver-MTC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 3 patient groups

Islet transplant

Experimental group

Description:

People with Type 1 diabetes undergoing islet transplantation

Treatment:

Dietary Supplement: Dietary intervention - supplements

Liver transplant

Experimental group

Description:

People with liver failure undergoing liver transplantation

Treatment:

Dietary Supplement: Dietary intervention - supplements

Control

Experimental group

Description:

Healthy normal people which serve as control group

Treatment:

Dietary Supplement: Dietary intervention - supplements