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Congenital Hyperinsulinism clinical trials

View clinical trials related to Congenital Hyperinsulinism.

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NCT ID: NCT06208215 Recruiting - Clinical trials for Congenital Hyperinsulinism

RZ358 Treatment for Congenital Hyperinsulinism

sunRIZE
Start date: January 11, 2024
Phase: Phase 3
Study type: Interventional

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 evaluate the longer-term safety and efficacy of RZ358 during a subsequent open-label extension (OLE) period.

NCT ID: NCT05687474 Recruiting - Cystic Fibrosis Clinical Trials

Baby Detect : Genomic Newborn Screening

Start date: September 1, 2022
Phase:
Study type: Observational

Newborn screening (NBS) is a global initiative of systematic testing at birth to identify babies with pre-defined severe but treatable conditions. With a simple blood test, rare genetic conditions can be easily detected, and the early start of transformative treatment will help avoid severe disabilities and increase the quality of life. Baby Detect Project is an innovative NBS program using a panel of target sequencing that aims to identify 126 treatable severe early onset genetic diseases at birth caused by 361 genes. The list of diseases has been established in close collaboration with the Paediatricians of the University Hospital in Liege. The investigators use dedicated dried blood spots collected between the first day and 28 days of life of babies, after a consent sign by parents.

NCT ID: NCT05597475 Recruiting - Obesity Clinical Trials

GLP1R-imaging in Post-RYGB Hypoglycemia

Start date: November 1, 2016
Phase: N/A
Study type: Interventional

In order to evaluate the difference in beta cell mass in patients with and without hyperinsulinemic hypoglycemia after Roux en Y gastric bypass (RYGB) investigators aim to compare quantitative PET imaging of the pancreas between these patient groups. These highly relevant data will provide investigators with more information on the possible role of beta cell mass in the mechanisms of hyperinsulinemic hypoglycemia bariatric surgery.

NCT ID: NCT05171751 Completed - Clinical trials for Octreotide Adverse Reaction

Efficacy and Safety Evaluation of Octreotide in the Treatment of Congenital Hyperinsulinemia

BCH
Start date: November 1, 2021
Phase:
Study type: Observational

To analyze and evaluate the efficacy and safety of octreotide subcutaneous injection in the treatment of diazazine-ineffective congenital hyperinsulinemia (CHI) in children.

NCT ID: NCT04909333 Completed - Clinical trials for Endogenous Hyperinsulinism

Exenatide-test for Diagnosing Endogenous Hyperinsulinemic Hypoglycemia

FAST
Start date: April 29, 2021
Phase: N/A
Study type: Interventional

This study is to evaluate the concept of the exenatide test for diagnosis of EHH (earlier induction of symptomatic hypoglycemia compared to placebo within 4 hours after injection).

NCT ID: NCT04836273 Completed - Clinical trials for Postprandial Hypoglycemia

Treatment of Post-bariatric Hypoglycaemia

SHERRY
Start date: August 20, 2021
Phase: Phase 2
Study type: Interventional

This is an investigator-initiated, proof-of-concept, randomised, double-blind, placebo-controlled, single-centre phase II study aiming to evaluate the efficacy, safety and tolerability of self-administered subcutaneous 120 µg dasiglucagon with an investigational trial device (i.e. a multi-dose reusable pen) for the treatment of postprandial hypoglycaemia after Roux-en-Y gastric bypass (RYGB) surgery. The study is divided into an in-patient and out-patient part. The primary aim of the study is to compare the effects of self-administered 120 µg dasiglucagon versus placebo on continuous glucose monitoring (CGM)-assessed time spent in hypoglycaemia in RYGB-operated individuals in an out-patient setting.

NCT ID: NCT04732416 Recruiting - Clinical trials for Congenital Hyperinsulinism

HM15136 Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)

Start date: October 28, 2021
Phase: Phase 2
Study type: Interventional

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). HM15136 will be administered once weekly in multiple doses to subjects in multiple age including pediatric to find appropriate exposure-response data.

NCT ID: NCT04720859 Recruiting - Clinical trials for Postprandial Hypoglycemia

Canagliflozin in Postprandial Hyperinsulinemic Hypoglycemia (CANA-PHH-RYGB)

CANA-PHH-RYGB
Start date: January 5, 2018
Phase: N/A
Study type: Interventional

Roux-en-Y gastric bypass (RYGB) is the most common surgical procedure for morbid obesity. However, it can present serious late complications, like postprandial hyperinsulinemic hypoglycemia (PHH). Recent data suggested an increase in intestinal SGLT1 after RYGB. However, there are no data on the inhibition of SLGT1 to prevent PHH in patients with prior RYBG. Objectives: To evaluate in patients that present PHH after RYGB: a) the effect of canagliflozin 300mg on the response to 100g glucose overload (OGTT); b) the pancreatic response after intra-arterial calcium stimulation. Material and methods: Prospective pilot study, including patients with PHH after RYGB, matched by age and gender with healthy controls. Basal OGTT and after 2-weeks of daily 300mg of canagliflozin will be performed. In addition, venous sampling after intra-arterial calcium stimulation of the pancreas will be performed.

NCT ID: NCT04706910 Recruiting - Parkinson Disease Clinical Trials

18F-DOPA II - PET Imaging Optimization

Start date: January 20, 2021
Phase: Phase 3
Study type: Interventional

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. Pediatric patients (less than 18 years old) with neuroblastoma. 3. Pediatric (less than 18 years old) or Adult patients (18 or older) with known or clinically suspected neuroendocrine tumor. 4. Adult patients (18 or older) with a clinical suspicion of Parkinson's disease or Lewy body dementia. 5. Pediatric (less than 18 years old) or Adult patients (18 or older) with brain tumors. Image optimization (the primary study objective) and gallbladder activity pattern (the secondary objective) will be evaluated.

NCT ID: NCT04652479 Completed - Clinical trials for Acquired Hyperinsulinemic Hypoglycemia

Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia

Start date: June 21, 2021
Phase: Phase 2
Study type: Interventional

The primary goal of this study is to evaluate the safety and efficacy of two different dosing regimens of an investigational drug called Avexitide in treating low blood sugar in patients with Acquired Hyperinsulinemic Hypoglycemia.