Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery

Hypoglycemia, Reactive Clinical Trial

Official title:

Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03514576
• Other study ID #: PasHypo
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: June 1, 2018
• Est. completion date: November 1, 2018

Study information

• Verified date: July 2018
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 5
• Est. completion date: November 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoglycemia
• Hypoglycemia, Reactive

Intervention

Drug:
• Pasireotide 0.3 MG/ML
See arm description

Diagnostic Test:
• Meal tolerance test (MTT)
Subjects will consume the liquid meal at baseline and blood will be drawn for continuous blood sampling.

Locations

Country	Name	City	State
Denmark	Zealand University Hospital	Køge

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in glucose (mmol/L) in response to a meal tolerance test (MTT)	Changes in incremental area under the curve (iAUC) for glucose, nadir glucose values, peak glucose values, time spent with glucose values in the hyperglycemic (>7.8 mmol/L) and the hypoglycemic (<3.9 mmol/L) range	From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
Secondary	Heart rate	Changes heart rate (beats/min) during the course of a meal tolerance test (MTT)	From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
Secondary	Serum insulin levels	Changes in insulin (pmol/L) in response to a meal tolerance test (MTT)	From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
Secondary	Serum C-peptide levels	Changes in C-peptide (nmol/L) in response to a meal tolerance test (MTT)	From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
Secondary	Plasma glucagon levels	Changes in glucagon (pmol/L) in response to a meal tolerance test (MTT)	From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
Secondary	Plasma GLP-1 levels	Changes in glucagon-like peptide 1 (pmol/L) in response to a meal tolerance test (MTT)	From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
Secondary	Blood pressure	Changes in blood pressure (mmHg) in response to a meal tolerance test (MTT)	From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion