GLP-1 Receptor Targeting in Diabetic and Healthy Individuals (GLP-1-CPOP)

November 27, 2014 updated by: Martin Gotthardt, Radboud University Medical Center

Clinical Proof-of-principle of the Determination of the Beta Cell Mass in Vivo by SPECT Imaging With the 111-In-labeled GLP-1 Analogue DTPA(Diethylenetriamine Pentaacetic Acid)-[K40]-Exendin 4

The purpose of the study is to determine whether there are differences in pancreatic uptake of the radiotracer between healthy individuals and patients with type 1 diabetes. If T1D patients have a markedly reduced uptake, the compound may be suitable for estimation of pancreatic beta cell mass, i.e. the cells in the pancreas that produce insulin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500 HB
        • Radboud University Nijmegen Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Type 1 Diabetes patients and healthy volunteers responding to advertisment

Description

Inclusion Criteria:

  • type 1 Diabetes

Exclusion Criteria:

  • breast feeding
  • pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Type 1 Diabetes
patients with long standing T1D
Other: radiolabeled Exendin
Healthy volunteer
healthy volunteers with normal glucose tolerance
Other: radiolabeled Exendin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pancreatic uptake of radiolabeled Exendin
Time Frame: 7 days
uptake will be given as counts per MBq injected activity as determined by calibrated SPECT/CT scanner with attenuation correction.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

March 18, 2013

First Submitted That Met QC Criteria

April 2, 2013

First Posted (Estimate)

April 5, 2013

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

November 27, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RUNMC-EX-BCM-2012
  • 2012-000619-10 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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