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

Primary Purpose

Immunosuppression, Hyperlipidemias, Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

Dietary intervention - supplements

About this trial

This is an interventional treatment trial for Immunosuppression focused on measuring Type 1 diabetes, Transplants, Immunosuppression, Hyperlipidemia, Nutrition Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

University of Alberta

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Islet transplant

Liver transplant

Control

Arm Description

People with Type 1 diabetes undergoing islet transplantation

People with liver failure undergoing liver transplantation

Healthy normal people which serve as control group

Outcomes

Primary Outcome Measures

Cholesterol and fatty acid synthesis

Secondary Outcome Measures

Blood lipid levels

Full Information

NCT ID

NCT00947635

First Posted

July 22, 2009

Last Updated

July 24, 2009

Sponsor

University of Alberta

Collaborators

Canadian Institutes of Health Research (CIHR)

1. Study Identification

Unique Protocol Identification Number

NCT00947635

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Completed

Study Start Date

November 2005 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Alberta

Collaborators

Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Immunosuppression, Hyperlipidemias, Diabetes Mellitus, Type 1

Keywords

Type 1 diabetes, Transplants, Immunosuppression, Hyperlipidemia, Nutrition Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Islet transplant

Arm Type

Experimental

Arm Description

People with Type 1 diabetes undergoing islet transplantation

Arm Title

Liver transplant

Arm Type

Experimental

Arm Description

People with liver failure undergoing liver transplantation

Arm Title

Control

Arm Type

Experimental

Arm Description

Healthy normal people which serve as control group

Intervention Type

Dietary Supplement

Intervention Name(s)

Dietary intervention - supplements

Intervention Description

Supplement bar & spread formulated with key nutrients (fish oil, phytosterols, almonds, soy protein) shown to help in reducing blood lipid levels

Primary Outcome Measure Information:

Title

Cholesterol and fatty acid synthesis

Time Frame

Pre-transplant, post-transplant (>3 months after transplant, up to 2 years) and post-dietary intervention (1 month after post-transplant measurement)

Secondary Outcome Measure Information:

Title

Blood lipid levels

Time Frame

Pre-transplant, post-transplant (>3 months after transplant, up to 2 years) and post-dietary intervention (1 month after post-transplant measurement)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael T Clandinin, PhD

Organizational Affiliation

University of Alberta

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alberta

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2P5

Country

Canada

12. IPD Sharing Statement

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

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