Visualizing Beta Cells in Patients With a History of Gestational Diabetes

What Was Tested

In this not phased trial, researchers set out to test Exenatide.

In order to evaluate the difference in beta cell mass in women with and without a history of gestational diabetes mellitus (GDM), investigators aim to compare quantitative PET imaging of the pancreas between these groups.

Investigators propose to measure uptake of 68Ga-NODAGA-exendin-4 in the pancreatic beta cells of these women as a measure for beta cell mass.

Furthermore, investigators aim to compare uptake of the radiolabeled tracer to beta cell function measured by laboratory parameters.

It had two arms (groups): Gestational diabetes (experimental) and Control (active comparator).

Women with a history of gestational diabetes.

Women without a history of gestational diabetes.

The registry classes the interventions as radiation.

More on the Plan

Gestational diabetes Insulin is produced by pancreatic beta cells and is needed for optimal glucose homeostasis.

In healthy individuals, the mass and function of beta cells changes to adapt to variations in insulin demand in the body.

By the time of delivery, beta cell function as well as beta cell mass return to normal levels.

When there is no sufficient compensation during pregnancy due to failure in beta cell expansion or function, gestational diabetes mellitus (GDM) occurs.

Who Took Part

The registry lists 24 planned participants were the target.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Pregnancy with diagnosis of GDM, within the last 5 years. No other previous pregnancies. Complete resolution of GDM after delivery. No evidence of T2D at the time of inclusion. BMI between 17 and 30.

The full record lists 12 inclusion and 5 exclusion criteria; among the exclusions: previous treatment (within 6 months) with synthetic exendin; breast feeding; current pregnancy.

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 2016-11-10 with completion listed for 2026-01-01.

It ran at 1 site in Netherlands.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Pancreatic uptake of 68Ga-NODAGA-exendin-4 (time frame: 1 year).

It also tracked 1 secondary outcome, for example C-peptide, HbA1c.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Exenatide in 24 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.