Determination of the mass of insulin-producing beta cells in the pancreas by means of a radioactive tracer molecule

• Conditions: patients with long-standing type 1 diabetes; MedDRA version: 14.1Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.1Level: HLGTClassification code 10018424Term: Glucose metabolism disorders (incl diabetes mellitus)System Organ Class: 10014698 - Endocrine disorders; MedDRA version: 14.1Level: HLTClassification code 10012602Term: Diabetes mellitus (incl subtypes)System Organ Class: 10014698 - Endocrine disorders; MedDRA version: 14.1Level: 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: EUCTR2012-000619-10-NL
• Lead Sponsor: Radboud University Nijmegen Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-19
• Last Update Posted: 31 July 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•21-60 years of age
•Long-standing T1D (>5 years) or healthy volunteer with normal glucose tolerance
•Body mass index (BMI) of 21-27
•No previous treatment with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors
•No measurable C-peptide in T1D patients (stimulated)
•Normal HbA1c (<7%) in healthy volunteers

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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Age <21 or >60 years
•T1D duration <5 years or pathologic glucose tolerance in healthy volunteers
•BMI <21 or >27
•Previous treatment with Exenatide or Dipeptidyl-Peptidase IV inhibitors
•Measurable C-peptide in T1D patients
•Elevated HbA1c values (>7%) in healthy volunteers

Study & Design

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