Etiology, Assessment and Treatment of Post-gastric Bypass Severe Hypoglycemia

What Was Tested

The trial (not phased) is built around Octreotide.

Post-gastric bypass hyperinsulinemic hypoglycemia is a relative rare but serious complication often seen months to years after gastric bypass surgery.

It had three arms (groups): Gastric bypass surgery, hypoglycemia (experimental), Gastric bypass surgery, asymptomatic (active comparator) and Controls (other).

Subjects with previous gastric bypass surgery (more then 1 year ago) and symptomatic hypoglycemia according to Whipples triade. These subjects will undergo an oral glucose tolerance test (OGGT), an isoglycemic intravenous glucose infusion (IIGI) and a 300 kcal liquid mixed meal. They will furthermore undergo two additional liquid mixed meal; one with concomitant treatment with synthetic Exendin 9-39 and another with treatment with Octreotide. All tests will be separated by at least one week.

Subjects with previous gastric bypass surgery (more then 1 year ago) without any signs of hypoglycemia. These subjects will undergo an oral glucose tolerance test (OGGT), an isoglycemic intravenous glucose infusion (IIGI) and a 300 kcal liquid mixed meal.

Healthy non-operated control subjects, matched on BMI, age and sex. These subjects will undergo an oral glucose tolerance test (OGGT), an isoglycemic intravenous glucose infusion (IIGI) and a 300 kcal liquid mixed meal.

The registry classes the interventions as dietary supplement and drug.

More on the Plan

Another remarkable effect of bariatric surgery, especially Roux-en-Y gastric bypass (RYGB), is the profound and durable resolution of clinical manifestations of type 2 diabetes.

The patients experience autonomic symptoms with tremor, palpitation, sweating and hunger, and symptoms of neuroglycopenia such as inability to concentrate, weakness, drowsiness and behavioral changes.

One issue complicating the characterization of post-gastric bypass surgery is that patients who have undergone bariatric surgery typically experience numerous post-prandial symptoms including the "dumping syndrome", which may be part of a continuum of post-gastric bypass hypoglycemia.

The researchers know that affected individuals have exaggerated insulin and glucagon-like peptide-1 response to meal consumption compared with asymptomatic individuals with prior gastric bypass surgery.

Who Took Part

33 actual participants took part.

It was open to people of any sex aged from 20 years up to 65 years.

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

Examples of who could join: Legally competent (habil). Age 20-65 years. Speak and understand Danish. Investigators verification of suitability.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: heart, liver or kidney disease; treatment with cortisol; current treatment with antidiabetic medication.

How the Study Was Run

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

In the crossover set-up each of the participants took both Octreotide and the comparison in turn, acting as their own control.

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

It started in 2013-06 with completion listed for 2016-03.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Changes in biomedical markers (eg. blood glucose) in response to a liquid meal.

It also tracked 1 secondary outcome, for example Continuous Glucose Monitoring as an indicator of post-gastric bypass hypoglycemia.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Octreotide in 33 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 Octreotide compound page, all human trials.