GLP1R-imaging in Hypoglycemia

What Was Tested

The trial (phase 1) is built around Exenatide.

Hyperinsulinemic hypoglycemia (HH) is a rare complication that occurs 1 to 5 years after gastric bypass surgery.

The underlying mechanism of this complication is not yet completely understood.

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

Patients with hypoglycemia after gastric bypass.

Patients without hypoglycemia after gastric bypass.

The registry classes the interventions as radiation.

More on the Plan

Hyperinsulinaemic hypoglycemia after bariatric surgery.

Non-invasive weight loss interventions such as diet, lifestyle or medication only have a moderate effect which is short lived.

The most performed and preferred bariatric surgery is Roux-en-Y Gastric Bypass (RYGB), which is a food restrictive and malabsorptive procedure.

A frequent late complication of RYGB is the dumping syndrome and a rare late complication is hyperinsulinaemic hypoglycemia (HH).

Who Took Part

12 planned participants were the target.

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

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

Examples of who could join: Signed informed consent. RYGB at least 2 years ago. Normal glucose levels before and after RYGB. Score \<7 on Sigstad's scoring system. Individual matched to HH group on age.

The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: anti-diabetic medication in the past 6 months; treatment with synthetic exendin in the past 6 months; liver failure.

How the Study Was Run

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

The Exenatide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Exenatide study: the participants and staff both knew the treatment.

It started in 2016-04-01 with completion listed for 2024-07-01.

It ran at 2 sites in Netherlands (2).

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Uptake of 68Ga-exendin in the pancreas of patients (time frame: 1 year).

It also tracked 1 secondary outcome, for example Correlation of tracer uptake with C-peptide and HbA1c.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized 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.