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

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00947635
Enrollment
46
Registered
2009-07-28
Start date
2005-11-30
Completion date
2009-06-30
Last updated
2009-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1, Hyperlipidemias, Immunosuppression

Keywords

Type 1 diabetes, Transplants, Immunosuppression, Hyperlipidemia, Nutrition Therapy

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.

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.

Interventions

DIETARY_SUPPLEMENTDietary intervention - supplements

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

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
University of Alberta
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Cholesterol and fatty acid synthesisPre-transplant, post-transplant (>3 months after transplant, up to 2 years) and post-dietary intervention (1 month after post-transplant measurement)

Secondary

MeasureTime frame
Blood lipid levelsPre-transplant, post-transplant (>3 months after transplant, up to 2 years) and post-dietary intervention (1 month after post-transplant measurement)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026