Congenital Hyperinsulinism Clinical Trial
Official title:
Role of Glucagon-Like Peptide-1 (GLP-1) in Congenital Hyperinsulinism: Effect of Exendin (9-39) on Glucose Requirements to Maintain Euglycemia
Verified date | May 2020 |
Source | Children's Hospital of Philadelphia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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. The secondary aims are to determine the therapeutic plasma levels, plasma half-life and pharmacokinetics of Exendin (9-39) during a 9-hour intravenous infusion.
Status | Terminated |
Enrollment | 14 |
Est. completion date | January 28, 2017 |
Est. primary completion date | January 28, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 12 Months |
Eligibility |
Inclusion Criteria: 1. Confirmed clinical diagnosis of congenital hyperinsulinism 2. Infants less than 12 months of age at study enrollment 3. Failure to respond to treatment with diazoxide Exclusion Criteria: 1. Evidence of a medical condition that might alter results, including kidney failure, severe liver dysfunction, severe respiratory or cardiac failure 2. Treatment with medications that may affect glucose metabolism at the time of initiation of study procedures, including: 1. Treatment with glucagon 4 hours prior to infusion (T=0) 2. Treatment with octreotide 24 hours prior to infusion (T=0) 3. Treatment with diazoxide 72 hours prior to infusion (T=0) 3. Suspected Beckwith-Wiedemann syndrome or other syndromic forms of congenital hyperinsulinism. |
Country | Name | City | State |
---|---|---|---|
United States | The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Diva De Leon |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Glucose Infusion Rate (GIR) | To assess the effect of Exendin (9-39) on glucose infusion rate, glucose infusion rate (GIR) over the last 2 hours of the treatment period was calculated by adding the total amount of intravenous glucose (mg) received over 2 hours divided by the weight (kg) and by time (120 min) during infusion of Exendin (9-39) and normal saline vehicle. | Up to 9 hours after the initiation of infusion | |
Primary | To Determine the Pharmacokinetics of Exendin (9-39) | The following PK variables of interest include AUC0-8, AUC0-t, maximal concentration (Cmax), time to maximal concentration (Tmax), concentration at end of infusion (Ceoi), steady state volume of distribution (Vss), clearance (CL) and half-life (t1/2) of Exendin (9-39). These will be derived through both non-compartmental and model-based methods. | Up to 12 hours after the initiation of infusion | |
Secondary | Safety and Tolerability of Exendin (9-39) | Number of participants with adverse events as a measure of safety and tolerability [evaluated by the result of laboratory safety tests (hematology, chemistry, urinalysis), vital signs, physical examinations, and 12-lead ECG] | Up to 24 hours post-infusion | |
Secondary | Mean Plasma Insulin | To assess the effect of Exendin (9-39) on plasma insulin levels, samples were collected at various time points during the infusion [Exendin (9-39) or vehicle] including: at the start of the infusion (T=0) and at 1, 5, and 9 hours post initiation of the infusion. | Up to 9 hours after the initiation of infusion | |
Secondary | Mean Plasma Glucose | To assess the effect of Exendin (9-39) on plasma glucose levels, samples were collected at various time points during the infusion [Exendin (9-39) or vehicle] including: at the start of the infusion (T=0) and at 1, 5, and 9 hours post initiation of the infusion. | Up to 9 hours after the initiation of infusion | |
Secondary | Mean Betahydroxybutyrate Levels | To assess the effect of Exendin (9-39) on mean betahydroxybutyrate levels, samples were collected at various time points during the infusion [Exendin (9-39) or vehicle] including: at the start of the infusion (T=0) and hourly up to 12-hours post initiation of the infusion. | Up to 12 hours after the initiation of infusion |
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