Hypoglycemia, Reactive Clinical Trial
Official title:
Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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