Treatment of Hypoglycemia Following Gastric Bypass Surgery

What Was Tested

The trial (phase 4) is built around Liraglutide and Pasireotide.

Roux-en-Y gastric bypass (RYGB) is one of the most commonly performed bariatric procedures used in the treatment of severe obesity.

It had five arms (groups): Glucobay (experimental), Januvia (experimental), Verapamil (experimental), Victoza (experimental) and Signifor (experimental).

The registry classes the interventions as device, dietary supplement and drug.

More on the Plan

Postprandial hyperinsulinemic hypoglycemia is typically seen years after RYGB and the symptoms vary from mild dizziness to confusion, loss of consciousness and seizures.

The condition is characterized by large postprandial blood glucose variations accompanied by exaggerated insulin and glucagon-like peptide 1 (GLP-1) responses.

At present, there are no treatment guidelines beside dietary recommendations.

The study is designed as a randomized, non-blinded cross-over study including five treatment arms.

Who Took Part

Enrollment: 11 actual participants took part.

It was open to women only aged from 25 years up to 60 years.

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

Examples of who could join: Symptoms of postprandial hyperinsulinemic hypoglycemia. More than 18 months since RYGB. Cobalamin \> 150 picomol/L. Negative human chorionic gonadotropin (hCG) urine test.

The full record lists 14 inclusion and 6 exclusion criteria; among the exclusions: treatment for cardiovascular disease; treatment with antipsychotics, antidepressants or anxiolytics; treatment for thyroid disease.

How the Study Was Run

Design: randomized, crossover and open-label.

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

Each person switched between Liraglutide and the comparison at some point, usually with a gap in between.

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

It started in 2015-10 with completion listed for 2017-04-08.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Changes in blood glucose (mmol/L) assessed by continuous glucose monitoring (CGM) (time frame: 6 days CGM will be performed at week 1, 3, 5, 7 and 11).

It also tracked 10 secondary outcomes, for example Changes in glucose (mmol/L) in response to a meal tolerance test (MTT), Changes heart rate (beats/min) during the course of a meal tolerance test (MTT), Changes in insulin (pmol/L) in response to a meal tolerance test (MTT), Changes in C-peptide (nmol/L) in response to a meal tolerance test (MTT), Changes in Insulin-like growth factor 1 (nmol/L) in response to a meal tolerance test (MTT) and Changes in glucagon (pmol/L) in response to a meal tolerance test (MTT).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide and Pasireotide in 11 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page and the Pasireotide compound page, all human trials.