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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pasireotide75 | Experimental | 75 micrograms Pasireotide 0.3 MG/ML s.c. before a meal tolerance test (MTT) |
|
| Pasireotide150 | Experimental | 150 micrograms Pasireotide 0.3 MG/ML s.c. before a meal tolerance test (MTT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pasireotide 0.3 MG/ML | Drug | See arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Serum insulin levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Caroline C Øhrstrøm, MD | Department of Medicine, Zealand University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zealand University Hospital | Køge | 4600 | Denmark |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 17, 2020 | |
| Reset | Aug 3, 2020 | |
| Release | Aug 28, 2020 | |
| Reset | Sep 18, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 17, 2020 | Aug 3, 2020 | |||
| Aug 28, 2020 |
| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| D006946 | Hyperinsulinism |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C517782 | pasireotide |
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| Meal tolerance test (MTT) | Diagnostic Test | Subjects will consume the liquid meal at baseline and blood will be drawn for continuous blood sampling. |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Sep 18, 2020 |