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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00947635
• Other study ID #: Islet-Liver-MTC
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 22, 2009
• Last updated: July 24, 2009
• Start date: November 2005
• Est. completion date: June 2009

Study information

• Verified date: July 2009
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Hyperlipidemias
• Immunosuppression

Intervention

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

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cholesterol and fatty acid synthesis		Pre-transplant, post-transplant (>3 months after transplant, up to 2 years) and post-dietary intervention (1 month after post-transplant measurement)	No
Secondary	Blood lipid levels		Pre-transplant, post-transplant (>3 months after transplant, up to 2 years) and post-dietary intervention (1 month after post-transplant measurement)	No