Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery

Zealand University Hospital

Status and phase: Unknown; Phase 4

Conditions: Hypoglycemia, Reactive

Treatments: Drug: Pasireotide 0.3 MG/ML; Diagnostic Test: Meal tolerance test (MTT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03514576

PasHypo

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Pasireotide75

Experimental group

Description:

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

Treatment:

Diagnostic Test: Meal tolerance test (MTT)

Drug: Pasireotide 0.3 MG/ML

Pasireotide150

Experimental group

Description:

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

Treatment:

Diagnostic Test: Meal tolerance test (MTT)

Drug: Pasireotide 0.3 MG/ML