Clinical trials: Hyperinsulinemic Hypoglycemia
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
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
Hyperinsulinemic Hypoglycemia, Post Gastrointestinal Tract Surgery Hypoglycaemia
Treatment Plan for an Individual Patient With Pasireotide for Hyperinsulinemic Hypoglycemia
Somatostatin analogues are a last resort for medical intervention in hyperinsulinemic hypoglycemia (HH). The hypoglycemia is very debilitating and can be even life threatening.
- Trial name
- NCT03103009
- Testing
- Pasireotide
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Colorado, Denver
Non-focal Congenital Hyperinsulinism
Towards Individualized Surgery in Non-focal Congenital Hyperinsulinism
Observational study in patients with non-focal congenital hyperinsulinism showing that restrictive surgery may improve the metabolic situation
- Trial name
- non-focal CHI (NCT02108730)
- Testing
- restrictive pancreatic resection
- Where
- Germany
- Volunteers
- 14 people
- Sponsor
- University Medicine Greifswald
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
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
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
Postprandial Hypoglycemia
Canagliflozin in Postprandial Hyperinsulinemic Hypoglycemia (CANA-PHH-RYGB)
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).
- Trial name
- CANA-PHH-RYGB (NCT04720859)
- Testing
- Canagliflozin 300 MG Oral Tablet
- Where
- Spain
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
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
Congenital Hyperinsulinism
A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
The objective of the trial is to evaluate the efficacy and safety of dasiglucagon administered as a subcutaneous (SC) infusion in reducing hypoglycemia in children with CHI.
- Trial name
- NCT03777176
- Testing
- Dasiglucagon, Standard of Care
- Where
- 10 sites in United States, Germany and 2 more
- Volunteers
- 32 people
- Sponsor
- Zealand Pharma
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
Glucose, High Blood, Exercise-Induced Hyperinsulinism
Exercise Type That Faster Reduces Postprandial Glycemia.
It is well established that a bout of 50 min of continuous moderate intensity exercise, improves insulin sensitivity up to 48 hours after the bout.
- Trial name
- GLYEXER (NCT04846751)
- Testing
- TYPE OF EXERCISE (OR REST)
- Where
- Spain
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- University of Castilla-La Mancha
Obesity, Hypoglycemia Post Gastric Bypass Surgery
GLP1R-imaging in Post-RYGB Hypoglycemia
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…
- Conditions
- Obesity, Hypoglycemia Post Gastric Bypass Surgery, Hyperinsulinemic Hypoglycemia
- Trial name
- NCT05597475
- Testing
- GLP-1R PET
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Rijnstate Hospital
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
Post Bariatric Hypoglycemia
Efficacy, Tolerability and Pharmacokinetics of Subcutaneous Exendin (9-39) in Patients With Post Bariatric Hypoglycemia
This study is designed to evaluate the efficacy, safety and pharmacokinetics of subcutaneous exendin (9-39) in subjects with post-bariatric hypoglycemia.
- Trial name
- NCT02771574
- Testing
- Lyo avexitide, Liq avexitide
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Tracey McLaughlin
Congenital Hyperinsulinism
Sandostatine® LP and Hyperinsulinism
To replace Sandostatine® in three daily subcutaneous injections by a single intramuscular injection of Sandostatine® LP per month in patients with a diffuse form of hyperinsulinism.
- Trial name
- NCT00987168
- Testing
- Sandostatine LP
- Where
- France
- Volunteers
- 10 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Endogenous Hyperinsulinaemic Hypoglycaemia
New Imaging Procedure for the Localisation of Insulinoma
Insulinoma: Insulinoma are rare, small insulin secreting neuroendocrine tumors. The only curative approach is the surgical excision. The preoperative detection remains a challenge.
- Trial name
- NCT02127541
- Testing
- Ga -exendin PET/CT, In- exendin SPECT/CT, MRI
- Where
- Switzerland
- Volunteers
- 52 people
- Sponsor
- University Hospital, Basel, Switzerland
Insulinoma, Nesidioblastosis
68Ga-NOTA-exendin-4 PET/CT for the Localization of Insulinoma and Diagnosis of Nesidioblastosis
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-exendin-4 in insulinoma and nesidioblastosis patients.
- Trial name
- NCT02560376
- Testing
- 68Ga-NOTA-exendin-4
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Peking Union Medical College Hospital
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
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