Glucagon Like Peptide 1 Receptor (GLP1R) Expression and Beta-cell Mass in Patients With Type 2 Diabetes

What Was Tested

This registered not phased trial tested Exenatide.

Validation of the exendin-based beta cell imaging technique in patients with type 2 diabetes.

It had two arms (groups): 111In-exendin-DTPA (experimental) and exendin-IRDye800CW (experimental).

Injection of 111In-exendin-DTPA for subsequent localization of the tracer in excised tissue using autoradiography.

Injection of exendin-4-IRDye800CW for subsequent localization of the tracer in excised tissue using fluorescence microscopy.

The registry classes the interventions as drug.

More on the Plan

Rationale: Reliable imaging biomarkers for non-invasive characterisation of beta-cell mass (BCM) are needed to aid understanding regarding the relationship between beta-cell mass and function during the course of type 2 diabetes (T2D).

This study will provide critical information necessary to validate the applicability of exendin-based imaging techniques in patients with T2D.

To date, only measurements of circulating C-peptide and insulin levels can be obtained, but these measures do not reflect beta-cell mass, only total beta-cell function.

Reliable imaging biomarkers for non-invasive characterisation of beta cell mass are therefore needed.

Who Took Part

Enrollment: 28 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: previous treatment with synthetic exendin or dipeptidyl-peptidase iv inhibitors within the past 3 months; breast feeding; pregnancy or the wist to become pregnant within 6 months.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Exenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2019-11-01 with completion listed for 2022-06-01.

It ran at 1 site in Netherlands.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): Pancreatic exendin uptake 111In-DTPA exendin-4. Pancreatic exendin uptake 111In-DTPA exendin-4. Beta cell function (time frame: The glucose tolerance test will be performed within a week before planned surgery).

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Exenatide in 28 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page, all human trials.