Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery

NCT ID: NCT03514576

Last Updated: 2018-07-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2018-11-01

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.

Conditions

Hypoglycemia, Reactive

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pasireotide75

75 micrograms Pasireotide 0.3 MG/ML s.c. before a meal tolerance test (MTT)

Group Type: EXPERIMENTAL

Pasireotide 0.3 MG/ML

Intervention Type: DRUG

See arm description

Meal tolerance test (MTT)

Intervention Type: DIAGNOSTIC_TEST

Subjects will consume the liquid meal at baseline and blood will be drawn for continuous blood sampling.

Pasireotide150

150 micrograms Pasireotide 0.3 MG/ML s.c. before a meal tolerance test (MTT)

Group Type: EXPERIMENTAL

Pasireotide 0.3 MG/ML

Intervention Type: DRUG

See arm description

Meal tolerance test (MTT)

Intervention Type: DIAGNOSTIC_TEST

Subjects will consume the liquid meal at baseline and blood will be drawn for continuous blood sampling.

Interventions

Pasireotide 0.3 MG/ML

See arm description

Intervention Type: DRUG

Meal tolerance test (MTT)

Subjects will consume the liquid meal at baseline and blood will be drawn for continuous blood sampling.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Signifor

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zealand University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Caroline Christfort Øhrstrøm

MD, ph.d. student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Caroline C Øhrstrøm, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, Zealand University Hospital

Locations

Zealand University Hospital

Køge, , Denmark

Countries

Denmark

Other Identifiers

PasHypo

Identifier Type: -

Identifier Source: org_study_id