GLP-1 Receptor Targeting in Diabetic and Healthy Individuals

Type 1 Diabetes Clinical Trial

— GLP-1-CPOP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01825148
• Other study ID #: RUNMC-EX-BCM-2012
• Secondary ID: 2012-000619-10
• Status: Completed
• Phase: N/A
• First received: March 18, 2013
• Last updated: November 27, 2014
• Start date: December 2012
• Est. completion date: May 2014

Study information

• Verified date: November 2014
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

• type 1 Diabetes

Exclusion Criteria:

• breast feeding

• pregnant

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Type 1 Diabetes

Intervention

Other:
• radiolabeled Exendin

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Center	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pancreatic uptake of radiolabeled Exendin	uptake will be given as counts per MBq injected activity as determined by calibrated SPECT/CT scanner with attenuation correction.	7 days	No