GLP1-imaging Before and After Bariatric Surgery

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Exenatide.

In order to evaluate the difference in beta cell mass in morbidly obese patients with type 2 diabetes mellitus (T2D) before and after Roux-en-Y gastric bypass (RYGB), investigators aim to compare quantitative PET imaging of the pancreas in this patient group before and after surgery.

Investigators propose to measure the uptake of 68Ga-NODAGA-exendin-4 in the pancreatic beta cells of these patients.

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

It had 1 arm (groups): RYGB patients (experimental).

Patients who will receive a RYGB surgery.

The registry classes the interventions as radiation.

More on the Plan

The prevalence of Type 2 Diabetes Mellitus (T2D) in the Netherlands is 600.000-800.000 and each year \~70.000 new patients are diagnosed.

Obese patients with T2D are also at risk to develop dyslipidemia and hypertension.

The burden of this disease affects their society as well.

Who Took Part

Enrollment: 12 planned participants were the target.

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

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

Examples of who could join: Signed informed consent. Only metformin usage as anti-diabetic medication. Insulin and/or sulfonylurea (SU) usage.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: fasting glucose \< 6 at time c-peptide was determined; liver failure; BMI \> 50 kg/m-2.

How the Study Was Run

It was run as a sequential and open-label study.

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 2016-10-07 with completion listed for 2023-07-01.

It ran at 2 sites in Netherlands (2).

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Pancreatic uptake of 68Ga-NODAGA-exendin-4 (time frame: 4 years).

It also tracked 2 secondary outcomes, for example T2D outcome and Beta cell function.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of Exenatide in 12 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.