Clinical Trial: Pasireotide in Hyperinsulinemic Hypoglycemia
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Pasireotide for Prevention of Hypoglycemia in Patients With Hyperinsulinemic Hypoglycemia
Brief Summary: This is a small controlled pilot study to assess the effect of subcutaneous pasireotide on preventing hypoglycemia due to hyperinsulinism, including congenital hyperinsulinism and insulinoma.
Detailed Summary:
Pasireotide is a somatostatin analog with affinity for several somatostatin receptors including those on pancreatic beta cells; when activated these receptors affect the secretion of glucagon and insulin. Pasireotide is also known to decrease glucagon-like peptide 1 (GLP-1) and gastric inhibitory polypeptide (GIP) secretion. Hyperglycemia is a well-documented adverse effect of pasireotide in its approved indications for treatment of Cushing's disease and acromegaly.
In light of this, the investigators hypothesize that pasireotide may be an effective therapy for hypoglycemia due to hyperinsulinism. Therefore a small controlled pilot study to assess the effect of subcutaneous (s.c.) pasireotide on preventing hypoglycemia due to hyperinsulinism over 7 hours of observation in both fasting and fed states is proposed.
Sponsor: Montefiore Medical Center
Current Primary Outcome: Hypoglycemia [ Time Frame: 7 hours ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Serum glucose regulators [ Time Frame: 7 hours ]
Original Secondary Outcome: Same as current
Information By: Montefiore Medical Center
Dates:
Date Received: February 9, 2017
Date Started: April 2017
Date Completion: April 2018
Last Updated: February 14, 2017
Last Verified: November 2016