Clinical trials: Hyperinsulinemic Hypoglycemia
Hyperinsulinism, Hypoglycemia Neonatal
Continuous Glucose Monitoring in Neonatal Hyperinsulinism
The investigators are studying the accuracy of Dexcom G6 continuous glucose monitors placed on babies with hyperinsulinism in the Miller Children's Hospital Neonatal Intensive Care Unit.
- Trial name
- NCT06363929
- Testing
- Dexcom G6 continuous glucose monitor
- Where
- United States
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- MemorialCare Health System
Congenital Hyperinsulinism
GLP-1 Receptor Expression in CHI
The primary objective is the in vivo and ex vivo investigation of the expression and distribution of the GLP-1R in the pancreas of CHI patients.
- Trial name
- GLP-1-CHI (NCT03768518)
- Testing
- 68Ga-exendin-4 PET/CT
- Where
- Netherlands
- Volunteers
- 40 people
- Sponsor
- Radboud University Medical Center
Congenital Hyperinsulinism
Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
The objective of the trial is to evaluate the efficacy of dasiglucagon in reducing glucose requirements in children with persistent congenital hyperinsulinism (CHI) requiring continuous intravenous (IV) glucose administration to…
- Trial name
- NCT04172441
- Testing
- dasiglucagon
- Where
- 6 sites in United States, Germany and 2 more
- Volunteers
- 12 people
- Sponsor
- Zealand Pharma
Congenital Hyperinsulinism
An Open-Label Multiple Dose Study of RZ358 in Patients With Congenital Hyperinsulinism
The objective of this trial is to evaluate the safety, tolerability and glucose-raising effects of RZ358 in patients with Congenital Hyperinsulinism (HI).
- Trial name
- NCT04538989
- Testing
- RZ358 Sequential Group Cohort 1, RZ358 Sequential Group Cohort 2, RZ358 Sequential Group Cohort 3
- Where
- 17 sites in United States, Bulgaria and 9 more
- Volunteers
- 23 people
- Sponsor
- Rezolute
Congenital Hyperinsulinism
RZ358 Treatment for Congenital Hyperinsulinism
The Phase 3 pivotal study is designed to evaluate the efficacy and safety of RZ358 for the treatment of congenital hyperinsulinism (HI) as add-on to standard-of-care (SOC) therapy compared to SOC alone over 24 weeks and to…
- Trial name
- sunRIZE (NCT06208215)
- Testing
- RZ358 (5-10 mg/kg) + SOC
- Where
- 18 sites in United States, Bulgaria and 11 more
- Volunteers
- 56 people
- Sponsor
- Rezolute
Congenital Hyperinsulinism
HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)
This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of HM15136 when used as add-on therapy in subjects with CHI with persistent hypoglycemia while on standard of care treatment (SoC).
- Trial name
- NCT04732416
- Testing
- HM15136
- Where
- 7 sites in United States, Germany and 3 more
- Volunteers
- 17 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Congenital Hyperinsulinaemic Hypoglycaemia, Octreotide Adverse Reaction
Efficacy and Safety Evaluation of Octreotide in the Treatment of Congenital Hyperinsulinemia
To analyze and evaluate the efficacy and safety of octreotide subcutaneous injection in the treatment of diazazine-ineffective congenital hyperinsulinemia (CHI) in children.
- Trial name
- BCH (NCT05171751)
- Testing
- Octreotide Injection
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Beijing Children's Hospital
Congenital Hyperinsulinism, Neuroblastoma
18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety
Single centre prospective cohort phase III study of 18F-DOPA PET/CT imaging in specific patient populations: 1. Pediatric patients with congenital hyperinsulinism 2. Pediatric patients with neuroblastoma 3.
- Conditions
- Congenital Hyperinsulinism, Neuroblastoma, Neuroendocrine Tumors, Parkinson Disease
- Trial name
- NCT03042416
- Testing
- 18F-DOPA
- Where
- Canada
- Volunteers
- 400 people
- Sponsor
- University of Alberta
Congenital Hyperinsulinism, Neuroblastoma
18F-DOPA II - PET Imaging Optimization
A single centre non-randomized, non-blinded phase III prospective cohort study of 18F-DOPA PET/CT imaging in specific patient populations: 1. Pediatric patients (less than 18 years old) with congenital hyperinsulinism. 2.
- Conditions
- Congenital Hyperinsulinism, Neuroblastoma, Parkinson Disease, Lewy Body Disease
- Trial name
- NCT04706910
- Testing
- 18F-DOPA, Furosemide Injection
- Where
- Canada
- Volunteers
- 800 people
- Sponsor
- University of Alberta
Seizures, Hypoglycemia
Blood Sugars in Children With Idiopathic Seizures.
The purpose of this study is to determine if there is a significant percentage of children with the diagnosis of idiopathic seizures who have undiagnosed or unrecognized hypoglycemia (low blood sugar).
- Conditions
- Seizures, Hypoglycemia, Hyperammonemia
- Trial name
- NCT00279851
- Where
- United States
- Sponsor
- Children's Mercy Hospital Kansas City
Congenital Hyperinsulinism (CHI)
Umbilical Cord Glucose
Congenital hyperinsulinism (HI) causes persistent neonatal hypoglycemia that, if untreated, can lead to neurodevelopmental impairments (NDI) such as cognitive delays, cerebral palsy, epilepsy, and blindness.
- Trial name
- Save The Brain (NCT07795047)
- Testing
- For the screening, the interventions will be glucose measurements (and possibly G-BOBH), while follow-up assessments will include Bayley testing, EEG, and MRI.
- Volunteers
- 50 people
- Sponsor
- Odense University Hospital
Congenital Hyperinsulinism
CSI-Glucagon for Prevention of Hypoglycemia in Children With Congenital Hyperinsulinism
This 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…
- Trial name
- NCT02937558
- Testing
- Glucagon
- Where
- 5 sites in United States
- Volunteers
- 5 people
- Sponsor
- Xeris Pharmaceuticals
Hyperinsulinism
Sirolimus for the Treatment of Hyperinsulinism
The purpose of this pilot study is to generate data to assess feasibility of study design/procedures and for formal sample size estimation for a larger multicenter study of the efficacy and safety of sirolimus in infants with…
- Trial name
- NCT02524639
- Testing
- Sirolimus
- Where
- United States
- Sponsor
- Children's Hospital of Philadelphia
Congenital Hyperinsulinism
Effect of Exendin-(9-39) on Glycemic Control in Subjects With Congenital Hyperinsulinism
The 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…
- Trial name
- NCT00571324
- Testing
- Exendin-(9-39), Vehicle
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Diva De Leon
Congenital Hyperinsulinism
Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism
This is an open-label, multinational, multicenter, long-term safety and efficacy extension trial in patients with Congenital Hyperinsulinism (CHI) who completed either ZP4207-17103 (NCT04172441) or ZP4207-17109 (NCT03777176)…
- Trial name
- NCT03941236
- Testing
- dasiglucagon
- Where
- 10 sites in United States, Germany and 2 more
- Volunteers
- 42 people
- Sponsor
- Zealand Pharma
Congenital Hyperinsulinism
Lanreotide Autogel Treatment of Patients With Congenital Hyperinsulinism of Infancy
The purpose of our study is to evaluate the efficacy and safety of Lanreotide Autogel in children with congenital hyperinsulinism already treated with Octreotide by pump.
- Trial name
- NCT01070758
- Testing
- Lanreotide autogel
- Where
- Israel
- Volunteers
- 3 people
- Sponsor
- Sheba Medical Center
Conservatively Treated CHI Patients
Long Term Glucose Metabolism in Conservatively Treated Patients With Congenital Hyperinsulinism
The purpose of this study is to continue follow up of conservatively treated CHI patients and to focus on their metabolic outcome, including frequency of hypoglycemia after discontinuing treatment and incidence of diabetes…
- Trial name
- NCT01819584
- Volunteers
- 30 people
- Sponsor
- Sheba Medical Center
Hyperinsulinism, Diabetes
Bionic Pancreas in Children With Hyperinsulinism and Post-Pancreatectomy Diabetes
This is a pilot study designed to determine if the bihormonal bionic pancreas provides improved blood glucose control, compared to the current standard of care, in individuals with hyperinsulinism who developed diabetes after…
- Conditions
- Hyperinsulinism, Diabetes, Pancreatic Diseases, Pancreatectomy; Hyperglycemia
- Trial name
- NCT03303196
- Testing
- Bihormonal Bionic Pancreas
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Children's Hospital of Philadelphia
Congenital Adrenal Hyperplasia, Familial Hyperinsulinemic Hypoglycemia 1
Baby Detect : Genomic Newborn Screening
Newborn screening (NBS) is a global initiative of systematic testing at birth to identify babies with pre-defined severe but treatable conditions.
- Conditions
- Congenital Adrenal Hyperplasia, Familial Hyperinsulinemic Hypoglycemia 1, Phosphoglucomutase 1 Deficiency, Maturity Onset Diabetes of the Young
- Trial name
- BabyDetect (NCT05687474)
- Where
- Belgium
- Volunteers
- 6,824 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de Liege
Congenital Hyperinsulinism
Effect of Exendin (9-39) on Glucose Requirements to Maintain Euglycemia
The primary aim of this study is to evaluate the effect of Exendin (9-39) on glucose requirements to maintain euglycemia in pediatric patients with congenital hyperinsulinism (CHI) who have failed medical therapy.
- Trial name
- NCT00835328
- Testing
- Exendin (9-39), Vehicle
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Diva De Leon