Clinical trials: Hyperinsulinemic Hypoglycemia
Congenital Hyperinsulinism (CHI), Beckwith-Wiedemann Syndrome
18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Subjects With Hyperinsulinemic Hypoglycemia
This purpose of this study is to determine the ability of an 18F-fluoro-L-dihydroxyphenylalanine (18F-DOPA) PET (Positron Emission Tomography) scan to detect a focal lesion of hyperinsulinism and determine the location in…
- Conditions
- Congenital Hyperinsulinism (CHI), Beckwith-Wiedemann Syndrome, Insulinoma
- Trial name
- NCT01916148
- Testing
- 18F-DOPA
- Where
- United States
- Sponsor
- Children's Hospital of Philadelphia
Diabetes
Use of a Hyperinsulinemic-hypyglycemic Clamp to Study Hypoglycemia: a Method Development Study
A hyperinsulinemic-hypoglycemic clamp is an experimental procedure, which allows for hypoglycemia to be studied in a safe and controlled manner.
- Trial name
- NCT03839511
- Testing
- Hyperinsulinemic-hypoglycemic clamp
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Pennington Biomedical Research Center
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
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
Endogenous Hyperinsulinism
Exenatide-test for Diagnosing Endogenous Hyperinsulinemic Hypoglycemia
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).
- Trial name
- FAST (NCT04909333)
- Testing
- Exenatide, 0.9% saline solution
- Where
- Switzerland
- Volunteers
- 29 people
- Sponsor
- University Hospital, Basel, Switzerland
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
Hyperinsulinemic Hypoglycemia
Glucagon Ready to Use (RTU) in Subjects With Hyperinsulinemic Hypoglycemia After Bariatric Surgery
This is a double-blind, placebo-controlled Phase 2 study to assess the efficacy, safety and tolerability of Glucagon RTU when administered to subjects with a history of bariatric surgery during episodes of post-postprandial…
- Trial name
- NCT03770637
- Testing
- Glucagon RTU
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- Xeris Pharmaceuticals
Postprandial Hypoglycemia
Empagliflozin for the Treatment of Postprandial Hypoglycemia
This randomized trial is to test whether a treatment with empagliflozin is superior to placebo in patients with postprandial hypoglycemia after bariatric surgery, that is if it improves health related quality of life (mentally or…
- Trial name
- EmpHy (NCT05036317)
- Testing
- Empagliflozin (Jardiance®;
- Where
- 3 sites in Switzerland
- Volunteers
- 40 people
- Sponsor
- University Hospital, Basel, Switzerland
Congenital Hyperinsulinism
18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism
The goal of this project is to determine the role of FDOPA/PET as a pre-operative diagnostic imaging procedure for differentiating focal and diffuse forms of congenital hyperinsulinism and locating focal lesions in the pancreas…
- Trial name
- DOPA PET (NCT04205604)
- Testing
- 18F-Fluoro Dopa Imaging
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Miguel Pampaloni
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
Hyperinsulinemic Hypoglycemia, Postprandial Hypoglycemia
Dasiglucagon in the Treatment of Postprandial Hypoglycaemia After Roux-en-Y Gastric Bypass
The aim of this study is investigating the effect of a novel glucagon analogue administration in gastric bypass operated individuals, who are reactive hypoglycemic.
- Trial name
- NCT03984370
- Testing
- ZP4207
- Where
- Denmark
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University Hospital, Gentofte, Copenhagen
Post-Bariatric Hypoglycemia
Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia
Severe hypoglycemia (low blood sugar)after gastric bypass surgery is an increasingly recognized condition, characterized by symptoms of hypoglycemia after eating and inappropriately elevated insulin concentrations that occur at…
- Trial name
- NCT04615546
- Testing
- Use of Continuous Glucose Monitor (CGM), Use of "Cardea Solo" monitoring
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Stanford University
Congenital Hyperinsulinism
Compassionate Use of SOM230 for Hyperinsulinemic/Hypoglycemia
Congenital hyperinsulinism is a rare condition that can cause life-threatening hypoglycemia. Current treatment for congenital hyperinsulinism is often suboptimal, and such individuals may respond to a new somatostatin analog…
- Trial name
- NCT02835131
- Testing
- Pasireotide
- Where
- United States
- Sponsor
- Montefiore Medical Center
Congenital Hyperinsulinism
A Single-Dose Open-Label Study of XOMA 358 in Subjects With Congenital Hyperinsulinism
The purpose of this study is to evaluate the safety and clinical pharmacology of a single dose pharmacokinetics and pharmacodynamics of XOMA 358 in subjects with hypoglycemia associated with congenital hyperinsulinism.
- Trial name
- NCT02604485
- Testing
- Cohort 1, Cohort 2, Cohort 3
- Where
- 2 sites in United States, United Kingdom
- Volunteers
- 10 people
- Sponsor
- XOMA (US) LLC
Roux-en-Y Gastric Bypass, Postprandial Hypoglycemia
Effect of Postprandial Hyperinsulinaemic Hypoglycaemia on Driving Performance.
The 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…
- Conditions
- Roux-en-Y Gastric Bypass, Postprandial Hypoglycemia, Driving Impaired
- Trial name
- DEEP1C (NCT04330196)
- Testing
- Oral glucose tolerance test
- Where
- Switzerland
- Volunteers
- 12 people
- Sponsor
- Lia Bally
Hypoglycemia
Role of GLP-1 in Hyperinsulinemic Hypoglycemia Post-bariatric Surgery
The purpose of this study is to evaluate the role of GLP-1 in causing extreme postprandial glucose reductions after bariatric surgery in a subset of patients who have severe symptomatic hypoglycemia.
- Trial name
- NCT02550145
- Testing
- Exendin (9-39)
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Tracey McLaughlin
Roux-en-y Gastric Bypass, Post Prandial Hypoglycemia
Evaluation of the Neuro-endocrine Response to Post-prandial Hyperinsulinaemic Hypoglycaemia.
The primary objective of this study is to assess the neuro-endocrine response to hypoglycaemia in PHH vs. non-PHH post-gastric bypass individuals.
- Trial name
- DEEP1B (NCT04334161)
- Testing
- Administration of glucose and controlled induction of hypoglycaemia.
- Where
- Switzerland
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Lia Bally
Congenital Hyperinsulinism, Insulinoma
Fluorodopa F 18 in Congenital Hyperinsulinism and Insulinoma
Low blood sugars are known to cause brain damage in newborn babies. One of the most common causes of low blood sugars persisting beyond the new born period is a condition called congenital hyperinsulinism (HI).
- Trial name
- NCT02021604
- Testing
- Fluorodopa F 18
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Cook Children's Health Care System
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
Hypoglycemia
GLP1R-imaging in Hypoglycemia
Hyperinsulinemic hypoglycemia (HH) is a rare complication that occurs 1 to 5 years after gastric bypass surgery. The underlying mechanism of this complication is not yet completely understood.
- Trial name
- NCT03182192
- Testing
- 68Ga-NODAGA-exendin-4 PET/CT
- Where
- 2 sites in Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center