Clinical trials: Congenital Hyperinsulinism
Hypoleptinemia, Generalized Lipodystrophy
Trial of Leptin Replacement Therapy in Patients With Lipodystrophy
Lipodystrophies represent a therapeutic challenge with regards to insulin resistance, hypertriglyceridemia and fatty liver which often is coupled with significant adipose tissue loss.
- Conditions
- Hypoleptinemia, Generalized Lipodystrophy, Partial Lipodystrophy, Insulin Resistance
- Trial name
- NCT00896298
- Testing
- Leptin
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Texas Southwestern Medical Center
Heart Defects, Congenital, Hyperglycemia
SPECS: Safe Pediatric Euglycemia in Cardiac Surgery
Critically ill children, including children undergoing heart surgery, commonly develop elevated blood glucose (also known as "blood sugar") levels during their illness, which can lead to poor health outcomes and an increased risk…
- Trial name
- SPECS (NCT00443599)
- Testing
- Insulin, Usual Care
- Where
- 2 sites in United States
- Volunteers
- 989 people
- Sponsor
- Boston Children's Hospital
Effects of Different Meals on the QT/QTc Interval, Insulin and Oral Hypoglycemic [Antidiabetic] Drugs Causing Adverse Effects in Therapeutic Use
Food and Insulin Effect on QT/QTC Interval of ECG
Moxifloxacin is routinely used as a probe to confirm assay sensitivity in thorough electrocardiogram (ECG) studies. It has been shown that a meal shortens the QT interval, which may affect pharmacokinetics (PK) and/or…
- Conditions
- Effects of Different Meals on the QT/QTc Interval, Insulin and Oral Hypoglycemic [Antidiabetic] Drugs Causing Adverse Effects in Therapeutic Use, C-Peptide Effects on the QT/QTc Interval, Moxifloxacin ECG Profile in Fed and Fasted State
- Trial name
- C11035 (NCT01642485)
- Testing
- Moxifloxacin 400 mg fasted, FDA breakfast, Continental breakfast
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Richmond Pharmacology Limited
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
Hyperglycemia, Hyperlipidemia
Healthy Volunteers Study of the Effects of Olanzapine and Ziprasidone
Primary Aim: To test the acute effects of olanzapine or ziprasidone administration, in comparison to placebo, on insulin sensitivity in antipsychotic-naïve healthy young men, measured as whole-body dextrose infusion rates…
- Trial name
- NCT00910988
- Testing
- Olanzapine, Ziprasidone
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
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
Polycystic Ovary Syndrome
Treating Inflammation in Polycystic Ovary Syndrome to Ameliorate Ovarian Dysfunction
Polycystic Ovary Syndrome (PCOS) is characterized by hyperandrogenism, ovulatory dysfunction and polycystic ovaries. Insulin resistance (IR) is a common feature of PCOS, and the resultant hyperinsulinemia is theorized to promote…
- Trial name
- TIN-PCOS-AOD (NCT03229408)
- Testing
- Salsalate
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Illinois Chicago
Congenital Hyperinsulinism (CHI), Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI)
Phase II Safety and Efficacy Study of 18FDOPA PET-CT in Children With Hyperinsulinemic Hypoglycemia
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.
- Trial name
- 18FDOPA (NCT01468454)
- Testing
- 18 F-DOPA
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- Children's Hospital of Philadelphia
Congenital Hyperinsulinism, Hyperinsulinism
Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism
Children 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…
- Conditions
- Congenital Hyperinsulinism, Hyperinsulinism, Persistent Hyperinsulinemic Hypoglycemia of Infancy, CHI
- Trial name
- NCT00674440
- Testing
- F-DOPA, PET scan
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- Children's Hospital of Philadelphia
Polycystic Ovary Syndrome
Study of Pharmacodynamics of LIK066 in Overweight and Obese Women With Polycystic Ovary Syndrome
The purpose of the study was to evaluate whether LIK066 can be developed for the treatment of polycystic ovary syndrome (PCOS) in overweight and obese women.
- Trial name
- PCOS (NCT03152591)
- Testing
- LIK066
- Where
- 5 sites in United States, Germany
- Volunteers
- 29 people
- Sponsor
- Novartis Pharmaceuticals
Congenital Hyperinsulinism
Effect of Exendin-(9-39) on Fasting Adaptation and Protein Sensitivity
The 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.
- Trial name
- NCT00897676
- Testing
- Exendin-(9-39)
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Diva De Leon
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
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
Obesity, Metabolic Syndrome
Effects of Human Leptin Replacement
This study will test the hypothesis that leptin contributes to the regulation of the dynamics of human endocrine function.
- Conditions
- Obesity, Metabolic Syndrome, Diabetes
- Trial name
- NCT00657605
- Testing
- Recombinant methionyl human leptin
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- University of Miami
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
Obesity, Metabolic Syndrome
Effects of Leptin Replacement in Children
To assess the endocrine and immune effects of leptin replacement in leptin-deficient children, from a consanguineous family. The hypothesis is that leptin replacement will have significant effects on endocrine function.
- Conditions
- Obesity, Metabolic Syndrome, Diabetes
- Trial name
- NCT00659828
- Testing
- Recombinant methionyl human leptin
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Miami
Acquired Hyperinsulinemic Hypoglycemia
Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia
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…
- Trial name
- NCT04652479
- Testing
- Avexitide
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Dr. Tracey McLaughlin, MD
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
Polycystic Ovary Syndrome, Anovulation
Inositol Supplementation to Treat PCOS (INSUPP-PCOS)
To determine if Inositol, a dietary supplement, will improve ovarian and adrenal androgen excess in women with Polycystic Ovarian Syndrome(PCOS).
- Conditions
- Polycystic Ovary Syndrome, Anovulation, Hyperandrogenism, Insulin Resistance
- Trial name
- INSUPP-PCOS (NCT03864068)
- Testing
- Inositol
- Where
- 2 sites in United States
- Volunteers
- 154 people
- Sponsor
- Milton S. Hershey Medical Center
Cystic Fibrosis-related Diabetes
Feasibility of Outpatient Closed Loop Control With the iLet Bionic Pancreas in Cystic Fibrosis Related Diabetes
The current study is designed to test the feasibility of the a wearable bionic pancreas system that automatically delivers insulin and glucagon can provide superior regulation of glycemia versus usual care for adults and children…
- Trial name
- NCT03258853
- Testing
- Bionic Pancreas, Usual Care
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Massachusetts General Hospital