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OpenTrials
Completed

NCT Number: NCT00947635

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

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.

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Key information

Conditions

Immunosuppression Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hyperlipidemias Immune System Diseases Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Alberta

Edmonton, Alberta, T6G 2P5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary intervention - supplements

Dietary Supplement

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Jul 28, 2009
Registry last updated
Jul 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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