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. Funding Source - FDA OODP.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Role of GLP-1 in Congenital Hyperinsulinism:Effect of Exendin-(9-39) on Fasting Adaptation and Protein Sensitivity|
- Blood Glucose Levels [ Time Frame: -60, 0, and every 30 minutes for 6 hours ] [ Designated as safety issue: No ]
- Plasma Insulin, C-Peptide, glucagon and intact GLP-1 levels [ Time Frame: -60, 0, and every 30 minutes for 6 hours ] [ Designated as safety issue: No ]
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||April 2017|
|Estimated Primary Completion Date:||April 2017 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
at time 0,placebo(0.9%NaCl) at a dose ranging from 100-500pmol/kg/min will be started and continue for 6 hours.
placebo (0.9% NaCl)
Other Name: (0.9% NaCl)
at time 0,exendin-(9-39) at a dose ranging from 100-500pmol/kg/min will be started and continue for 6 hours.
Other Name: Exendin-(9-39)
This is a placebo controlled study with randomized crossover design to evaluate the effect of the glucagon-like peptide-1 (GLP-1) receptor antagonist, exendin-(9-39), on fasting blood glucose levels, protein-induced hypoglycemia, and fasting tolerance of subjects with congenital hyperinsulinism due to mutations in the ATP- sensitive potassium channel (KATP) channel.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897676
|Contact: Stephanie Givler, BS, CCRCfirstname.lastname@example.org|
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Stephanie Givler, BS 267-426-7622 email@example.com|
|Principal Investigator: Diva D De Leon, MD|
|Sub-Investigator: Charles A Stanley, MD|
|Principal Investigator:||Diva D DeLeon, MD||Children's Hospital of Philadelphia|