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

This study has been completed.
Sponsor:
Collaborator:
Canandian Institutes of Health Research
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00947635
First received: July 22, 2009
Last updated: July 24, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Immunosuppression
Hyperlipidemias
Diabetes Mellitus, Type 1
Dietary Supplement: Dietary intervention - supplements
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cholesterol and Fatty Acid Synthesis in Islet and Liver Transplant Patients and Effect of Dietary Intervention

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: November 2005
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00947635

Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2P5
Sponsors and Collaborators
University of Alberta
Canandian Institutes of Health Research
Investigators
Principal Investigator: Michael T Clandinin, PhD University of Alberta
  More Information

No publications provided

Responsible Party: Dr. Michael T. Clandinin, University of Alberta
ClinicalTrials.gov Identifier: NCT00947635     History of Changes
Other Study ID Numbers: Islet-Liver-MTC
Study First Received: July 22, 2009
Last Updated: July 24, 2009
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by University of Alberta:
Type 1 diabetes
Transplants
Immunosuppression
Hyperlipidemia
Nutrition Therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hyperlipidemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on July 24, 2014