NCT00947635

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 28, 2009

Completed
Last Updated

July 28, 2009

Status Verified

July 1, 2009

Enrollment Period

3.6 years

First QC Date

July 22, 2009

Last Update Submit

July 24, 2009

Conditions

ImmunosuppressionHyperlipidemiasDiabetes Mellitus, Type 1

Keywords

Type 1 diabetesTransplantsImmunosuppressionHyperlipidemiaNutrition Therapy

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • 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)

Study Arms (3)

Islet transplant

EXPERIMENTAL

People with Type 1 diabetes undergoing islet transplantation

Dietary Supplement: Dietary intervention - supplements

Liver transplant

EXPERIMENTAL

People with liver failure undergoing liver transplantation

Dietary Supplement: Dietary intervention - supplements

Control

EXPERIMENTAL

Healthy normal people which serve as control group

Dietary Supplement: Dietary intervention - supplements

Interventions

Dietary intervention - supplementsDIETARY_SUPPLEMENT

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

ControlIslet transplantLiver transplant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • on islet or liver transplant list
  • post-transplant \>3 months
  • physically able to participate in study and intervention

You may not qualify if:

  • \< 18 years of age
  • family history of premature cardiovascular disease or familial hyperlipidemia (control subjects)
  • cholestatic diseases (liver transplant patients)
  • type 2 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2P5, Canada

Location

MeSH Terms

Conditions

HyperlipidemiasDiabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusGlucose Metabolism DisordersEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Michael T Clandinin, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 22, 2009

First Posted

July 28, 2009

Study Start

November 1, 2005

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

July 28, 2009

Record last verified: 2009-07

Locations

CA(1)