NCT01050166

Brief Summary

The purpose of the study is to determine whether human islets labeled by iron contrast agents could be imaged using magnetic resonance after transplantation into the liver of Type 1 diabetic recipients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2008

Longer than P75 for all trials

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

August 15, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 15, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2012

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2012

Completed
Last Updated

April 26, 2021

Status Verified

April 1, 2021

Enrollment Period

4.3 years

First QC Date

January 14, 2010

Last Update Submit

April 22, 2021

Conditions

Type 1 Diabetes Mellitus

Keywords

islet transplantationmagnetic resonanceType 1 DM

Outcome Measures

Primary Outcomes (1)

  • Evidence of safety and efficacy of MRI imaging of transplanted human labeled islets

    1 year

Study Arms (1)

Labeled islets

Type 1 diabetic recipients after islet transplantation with islets labeled by iron contrast agent

Other: Transplantation of labeled islets

Interventions

Transplantation of labeled isletsOTHER
Labeled islets

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cohort will be selected from residents of Czech republic

You may qualify if:

  • Type 1 diabetes mellitus
  • normal renal parameters
  • hypoglycaemia unawareness or rapid progression of diabetic retinopathy or neuropathy

You may not qualify if:

  • acute and chronic liver disease
  • malignancy
  • acute infection
  • serious cardiovascular disease
  • coagulopathy
  • portal hypertension
  • presence of metal protesis, cardio-stimulators, or other metal material in the body

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes Center, Institute for Clinical and Experimental Medicine

Prague, 14000, Czechia

Location

Related Publications (1)

  • Saudek F, Jirak D, Girman P, Herynek V, Dezortova M, Kriz J, Peregrin J, Berkova Z, Zacharovova K, Hajek M. Magnetic resonance imaging of pancreatic islets transplanted into the liver in humans. Transplantation. 2010 Dec 27;90(12):1602-6. doi: 10.1097/tp.0b013e3181ffba5e.

    PMID: 21197715RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Frantisek Saudek, MD, DrSc

    Institute for Clinical and Experimental Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD., prof.

Study Record Dates

First Submitted

January 14, 2010

First Posted

January 15, 2010

Study Start

August 15, 2008

Primary Completion

December 15, 2012

Study Completion

December 31, 2012

Last Updated

April 26, 2021

Record last verified: 2021-04

Locations

CZ(1)