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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00947635
First Posted: July 28, 2009
Last Update Posted: July 28, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
University of Alberta
  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: 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

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) ]

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) ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2P5
Sponsors and Collaborators
University of Alberta
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Michael T Clandinin, PhD University of Alberta
  More Information

Responsible Party: Dr. Michael T. Clandinin, University of Alberta
ClinicalTrials.gov Identifier: NCT00947635     History of Changes
Other Study ID Numbers: Islet-Liver-MTC
First Submitted: July 22, 2009
First Posted: July 28, 2009
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:
Diabetes Mellitus
Hyperlipidemias
Hyperlipoproteinemias
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dyslipidemias
Lipid Metabolism Disorders
Autoimmune Diseases
Immune System Diseases