Pramlintide (Symlin) for the Treatment of Hypoglycemia Following Gastric Bypass Surgery

What Was Tested

In this phase 4 trial, researchers set out to test Amylin (Islet Amyloid Polypeptide).

It had two arms (groups): Baseline (no intervention) and Pramlintide (experimental).

Baseline Arm/Phase 1, is comprised of study visits 1 and 2. Visit 1: Screening visit. Eligible individuals who provided informed consent were asked to keep a 3-day log of food intake, blood glucose (8 per day), as well as any hypoglycemic symptoms, concurrent with a 3 day period of blinded (masked) continuous glucose monitoring device wear. Visit 2: a baseline mixed meal tolerance test was performed. Glucose, hormonal responses, and satiety were assessed. Glucose and symptom logs were reviewed.

The registry classes the interventions as drug.

More on the Plan

This study is an open-label short-term proof of concept study.

Pramlintide will be prescribed for 8 weeks.

The study will not be randomized or blinded.

Briefly, participants in this study will be asked to complete 4 study visits.

Who Took Part

22 actual participants took part.

It was open to people of any sex aged from 21 years up to 65 years.

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

Examples of who could join: Severe hypoglycemic episodes post-gastric bypass surgery. Normal fasting glucose. Age 21 to 65.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: hypoglycemia in the fasting state (greater than 12 hours fast); use of medications that affect gastrointestinal motility (e.g., cisapride, metoclopramide); hepatic disease (defined as liver enzymes \> 2 times upper normal limit for alanine transaminase (alt) and aspartate aminotransferase (ast)).

How the Study Was Run

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

Everyone knew when Amylin (Islet Amyloid Polypeptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2010-02-02 with completion listed for 2016-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Plasma Glucose Levels in Response to Mixed Meal Testing - Area Under the Curve for Plasma Glucose.

It also tracked 10 secondary outcomes, for example Continuous Glucose Monitoring Maximum Sensor Glucose Values Prior to (Baseline) and During Pramlintide Therapy, Continuous Glucose Monitoring Minimum Sensor Glucose Prior to (Baseline) and During Pramlintide Therapy, Plasma Insulin Levels in Response to Mixed Meal Testing - Area Under the Curve for Plasma Insulin, Satiety Score During Mixed Meal Testing at 120 Minutes, Dumping Score During Mixed Meal Testing at Baseline and During Treatment With Pramlintide and Nadir Plasma Glucose Levels During Mixed Meal Testing at Baseline and During Treatment With Pramlintide.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Amylin (Islet Amyloid Polypeptide) in 22 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Amylin (Islet Amyloid Polypeptide) compound page, all human trials.