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

July 24, 2009 updated by: University of Alberta
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2P5
        • University of Alberta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Islet transplant
People with Type 1 diabetes undergoing islet transplantation
Dietary supplement: Dietary intervention - supplements
Supplement bar & spread formulated with key nutrients (fish oil, phytosterols, almonds, soy protein) shown to help in reducing blood lipid levels
Experimental: Liver transplant
People with liver failure undergoing liver transplantation
Dietary supplement: Dietary intervention - supplements
Supplement bar & spread formulated with key nutrients (fish oil, phytosterols, almonds, soy protein) shown to help in reducing blood lipid levels
Experimental: Control
Healthy normal people which serve as control group
Dietary supplement: Dietary intervention - supplements
Supplement bar & spread formulated with key nutrients (fish oil, phytosterols, almonds, soy protein) shown to help in reducing blood lipid levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Michael T Clandinin, PhD, University of Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

July 22, 2009

First Submitted That Met QC Criteria

July 24, 2009

First Posted (Estimate)

July 28, 2009

Study Record Updates

Last Update Posted (Estimate)

July 28, 2009

Last Update Submitted That Met QC Criteria

July 24, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Islet-Liver-MTC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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