An Open-Label Multiple Dose Study of RZ358 in Patients With Congenital Hyperinsulinism
Congenital HyperinsulinismThe objective of this trial is to evaluate the safety, tolerability and glucose-raising effects of RZ358 in patients with Congenital Hyperinsulinism (HI).
Effect of Exendin-(9-39) on Fasting Adaptation and Protein Sensitivity
Congenital HyperinsulinismThe purpose of this study is to examine the effects of exendin-(9-39) on fasting blood glucose and protein induced hypoglycemia on subjects with Congenital Hyperinsulinism. Funding Source - FDA Office of Orphan Products Development (OODP).
Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism
Congenital HyperinsulinismHyperinsulinism3 moreChildren with congenital hyperinsulinism (CHI) have low blood sugar, and some of these children may require surgery. In this study, researchers affiliated with the University of Pennsylvania will test how well a radioactive drug (called F-DOPA) can detect a form of hyperinsulinism that may be cured by surgery. Eligible participants in this study will have positron emission tomography (PET) scans with F-DOPA prior to surgery.
18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety
Congenital HyperinsulinismNeuroblastoma3 moreSingle centre prospective cohort phase III study of 18F-DOPA PET/CT imaging in specific patient populations: Pediatric patients with congenital hyperinsulinism Pediatric patients with neuroblastoma Pediatric or Adult patients with suspected extra-pancreatic neuroendocrine tumor Adult patients with a clinical suspicion of Parkinson's disease Pediatric or Adult patients with primary brain tumors This study will evaluate the biodistribution and safety of 18F-DOPA produced at the Edmonton PET Centre.
New Imaging Procedure for the Localisation of Insulinoma
Endogenous Hyperinsulinaemic HypoglycaemiaInsulinoma: Insulinoma are rare, small insulin secreting neuroendocrine tumors. The only curative approach is the surgical excision. The preoperative detection remains a challenge. A non-invasive, highly sensitive tool in localizing the insulinomas would be appreciated in the preoperative work-up of these patients. To this aim Glucagon-like peptide-1 receptor (GLP-1R) imaging (Single Photon Emission Computer Tomography co-registered with a CT; SPECT/CT) could be a convenient tool. The possibly more sensitive approach of targeting GLP-1R using Positron emission tomography (PET/CT) methodology has not been investigated in patients so far.
Phase II Safety and Efficacy Study of 18FDOPA PET-CT in Children With Hyperinsulinemic Hypoglycemia...
Congenital Hyperinsulinism (CHI)Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI)Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these children may require surgery to remove part or all of their pancreas. In this study, researchers will test how well a radioactive drug, 18-labeled L-fluorodeoxyphenylalanine (called F-DOPA) can detect a form of hyperinsulinism (focal HI) that may be cured by surgery. Eligible participants in this study will have positron emission tomography/computerized tomography (PET/CT) scans with F-DOPA prior to surgery.
CSI-Glucagon for Prevention of Hypoglycemia in Children With Congenital Hyperinsulinism
Congenital HyperinsulinismThis is a Phase 2, multi-center, randomized, placebo-controlled, double-blind trial with open-label follow-up designed to assess the efficacy of Xeris Glucagon delivered as a continuous subcutaneous infusion to prevent hypoglycemia with lower intravenous glucose infusion rates in children < 1 year of age with congenital hyperinsulinism.
Pasireotide in Hyperinsulinemic Hypoglycemia
Congenital HyperinsulinismInsulinoma1 moreThis is a small controlled pilot study to assess the effect of subcutaneous pasireotide on preventing hypoglycemia due to hyperinsulinism, including congenital hyperinsulinism and insulinoma.
Effect of Postprandial Hyperinsulinaemic Hypoglycaemia on Driving Performance.
Roux-en-Y Gastric BypassPostprandial Hypoglycemia1 moreThe primary objective of this study is to assess the effect of the natural course of postprandial hypoglycemia vs. a postprandial euglycaemic condition on driving performance in individuals with confirmed postprandial hyperinsulinaemic hypoglycaemia after gastric-bypass surgery.
Effect of Exendin-(9-39) on Glycemic Control in Subjects With Congenital Hyperinsulinism
Congenital HyperinsulinismThe purpose of this study is to determine if Exendin-(9-39), an antagonist of the glucagon-like peptide-1 (GLP-1) receptor with effects on the pancreatic beta cell, increases fasting blood glucose levels in subjects with congenital hyperinsulinism.