Effect of Exendin-(9-39) on Fasting Adaptation and Protein Sensitivity

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2017-01-31

Brief Summary

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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 Office of Orphan Products Development (OODP).

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Detailed Description

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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.

Conditions

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Congenital Hyperinsulinism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

In a random crossover design, subjects were assigned to either intervention (6 hour infusion of exendin( 9-39) at a dose range of 100-500pmol/kg/min) or vehicle (6hr infusion of 0.9%NaCl)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vehicle first, then Exendin-(9-39)

An infusion of vehicle (0.9%NaCl) will run for 60 minutes(time -60 to 0) before starting the study infusion of vehicle or exendin-(9-39). At time 0, vehicle (0.9%NaCl) will be started and will continue for 6 hours. The following day, at time 0, exendin-(9-39) at a dose ranging from 100-500pmol/kg/min will be started and continue for 6 hours. During both infusions, blood glucose, insulin, c-peptide, GLP-1, and glucagon will be measured every 30 minutes.

Group Type OTHER

Exendin-(9-39)

Intervention Type DRUG

100-500pmol/kg/min

placebo

Intervention Type DRUG

placebo (0.9% NaCl)

Exendin-(9-39) first then Vehicle.

An infusion of vehicle (0.9%NaCl) will run for 60 minutes(time -60 to 0) before starting the study infusion of vehicle or exendin-(9-39). . At time 0, exendin-(9-39) at a dose ranging from 100-500pmol/kg/min will be started and continue for 6 hours. The following day, at time 0, vehicle (0.9%NaCl) will be started and will continue for 6 hours. During both infusions, blood glucose, insulin, c-peptide, GLP-1, and glucagon will be measured every 30 minutes.

.

Group Type OTHER

Exendin-(9-39)

Intervention Type DRUG

100-500pmol/kg/min

placebo

Intervention Type DRUG

placebo (0.9% NaCl)

Interventions

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Exendin-(9-39)

100-500pmol/kg/min

Intervention Type DRUG

placebo

placebo (0.9% NaCl)

Intervention Type DRUG

Other Intervention Names

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(0.9% NaCl)

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of hyperinsulinism
* Mutation analysis results demonstrating KATP channel defect
* Age 6 months to 18 years with
* Persistent hypoglycemia

Exclusion Criteria

* Current therapy with medications that may affect glucose metabolism such as octreotide, diazoxide, high dose glucocorticoids, adrenergic agents, etc. Subjects will be eligible to participate if the last dose of octreotide is given 48 hrs before study day 1 and the last dose of diazoxide is given 72 hours before study day 1
* Evidence of a medical condition that might alter results or compromised the elimination of the peptide, including active infection, kidney failure, severe liver dysfunction, severe respiratory or cardiac failure
* Pregnancy
* Subjects with milk protein allergy will be excluded for participating in studies involving protein tolerance test

Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No