Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery

What Was Tested

In this phase 4 trial, researchers set out to test Pasireotide.

Postprandial hyperinsulinemic hypoglycemia is a well-known and potentially severe complication of Roux-en-Y gastric bypass (RYGB), and the treatment options are limited.

It had two arms (groups): Pasireotide75 (experimental) and Pasireotide150 (experimental).

The registry classes the interventions as diagnostic test and drug.

More on the Plan

Symptoms vary from dizziness and palpitations to confusion, loss of consciousness and convulsions.

At present there are few treatment options available for RYGB patients with PHH and most of them rely on dietary changes that are difficult to adhere to.

Blood samples will be collected throughout the meal test at predefined time points and will be analyzed for glucose, insulin, C-peptide, GLP-1 and glucagon levels.

Who Took Part

The registry lists 5 planned participants were the target.

It was open to women only aged from 18 years up to 65 years.

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

Examples of who could join: Negative human chorionic gonadotropin (hCG) urine test.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: treatment for cardiovascular disease; treatment with antipsychotic medication; treatment for thyroid disease.

How the Study Was Run

The set-up was non-randomized, crossover and open-label.

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

Being open-label, the Pasireotide study did not mask who received what.

It started in 2018-06-01 with completion listed for 2018-08-01.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Changes in glucose (mmol/L) in response to a meal tolerance test (MTT) (time frame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion).

It also tracked 6 secondary outcomes, for example Heart rate, Serum insulin levels, Serum C-peptide levels, Plasma glucagon levels, Plasma GLP-1 levels and Blood pressure.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Pasireotide in 5 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 Pasireotide compound page, all human trials.