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

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ClinicalTrials.gov Identifier: NCT00947635
Recruitment Status : Completed
First Posted : July 28, 2009
Last Update Posted : July 28, 2009
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cholesterol and Fatty Acid Synthesis in Islet and Liver Transplant Patients and Effect of Dietary Intervention
Study Start Date : November 2005
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 Measures :
  1. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00947635


Locations
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Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2P5
Sponsors and Collaborators
University of Alberta
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Michael T Clandinin, PhD University of Alberta
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Responsible Party: Dr. Michael T. Clandinin, University of Alberta
ClinicalTrials.gov Identifier: NCT00947635    
Other Study ID Numbers: Islet-Liver-MTC
First Posted: July 28, 2009    Key Record Dates
Last Update Posted: July 28, 2009
Last Verified: July 2009
Keywords provided by University of Alberta:
Type 1 diabetes
Transplants
Immunosuppression
Hyperlipidemia
Nutrition Therapy
Additional relevant MeSH terms:
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Hyperlipidemias
Hyperlipoproteinemias
Diabetes Mellitus, Type 1
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases