Visualizing beta cells after islet transplantatio

Phase 1

• Conditions: Intrahepatic islet transplantation in type 1 diabetes patients; MedDRA version: 18.0Level: HLGTClassification code 10018424Term: Glucose metabolism disorders (incl diabetes mellitus)System Organ Class: 10014698 - Endocrine disorders; MedDRA version: 18.0Level: HLTClassification code 10012602Term: Diabetes mellitus (incl subtypes)System Organ Class: 10014698 - Endocrine disorders; MedDRA version: 18.0Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 18.0Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2015-000821-35-NL
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-09
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Patients:
-> 18 years old
-T1D patient undergone islet transplantation
-Clinically proven functional islet graft (stimulated C-peptide > 0.8 nmol/L)
-Signed informed consent
Healthy volunteers:
-> 18 years old
-Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Treatment with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors within the last 3 months
-Breast feeding
-Pregnancy or the wish to become pregnant within 6 months
-Affected kidney function ? Calculated creatinine clearance below 40ml/min (clearance of radiopharmaceutical causes greatest radiation dose to the kidneys)
-Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range (45 U/L).
-Age < 18 years
-No signed informed consent

-Elevated HbA1c (for healthy volunteers)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified