Clinical trial NCT03514576: Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery
Official title: Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypoglycemia, Reactive
Keywords: gastric bypass
hypoglycemia
hyperinsulinemia
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2018-05-02
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Postprandial hyperinsulinemic hypoglycemia is a well-known and potentially severe complication of Roux-en-Y gastric bypass (RYGB), and the treatment options are limited. Pasireotide has shown to be effective in preventing hypoglycemia in RYGB operated subjects, however treatment often leads to increased hyperglycemia.

The purpose of this study is to investigate two doses of pasireotide that are lower than doses previously used in RYGB operated subjects with postprandial hyperinsulinemic hypoglycemia.

Detailed description: With the growing number of RYGB operated subjects the attention on complications such as postprandial hyperinsulinemic hypoglycemia (PHH) has increased. PHH is characterized by increased glycemic variability and hypoglycemic episodes occurring 2-3 hours after a meal together with a markedly increase in insulin and glucagon-like-peptide 1 (GLP-1) levels. 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.

Pasireotide has been shown to reduce hypoglycemia in RYGB operated subjects with PHH, but often leads to increased hyperglycemia as well.

The purpose of the study is to investigate two doses of pasireotide in RYGB operated subjects with PHH.

Each subject will undergo two meal tolerance test (MTT) preceded by either 75 µg or 150 µg of pasireotide. 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.

Eligibility criteria: Inclusion Criteria:

* RYGB operated patients with documented hypoglycemia (blood glucose \<3.9 mmol/L) who have previously completed the study 'Treatment of hypoglycemia following gastric bypass surgery' (HypoGB2015)
* Hemoglobin \> 7,3 mmol/L
* Negative human chorionic gonadotropin (hCG) urine test
* Females of reproductive age: use of safe contraception

Exclusion Criteria:

* Treatment for cardiovascular disease
* Treatment with antipsychotic medication
* Treatment for thyroid disease
* Prior medical treatment of postprandial hyperinsulinemic hypoglycemia
* Prior allergic reactions to the study medicine

Primary outcomes:
measure: Changes in glucose (mmol/L) in response to a meal tolerance test (MTT)
timeFrame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
Secondary outcomes:
measure: Heart rate
timeFrame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
measure: Serum insulin levels
timeFrame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
measure: Serum C-peptide levels
timeFrame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
measure: Plasma glucagon levels
timeFrame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
measure: Plasma GLP-1 levels
timeFrame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
measure: Blood pressure
timeFrame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Zealand University Hospital
Study officials:
affiliation: Department of Medicine, Zealand University Hospital
name: Caroline C Øhrstrøm, MD
role: PRINCIPAL_INVESTIGATOR
References: