Completed

Short Term Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism

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What is being tested

recombinant human insulin-like growth factor I

Drug
Who is being recruted

Metabolic Diseases+6

+ Nutritional and Metabolic Diseases

+ Pathologic Processes

From 1 Months to 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: May 1998
See protocol details

Summary

Principal SponsorFDA Office of Orphan Products Development
Last updated: March 25, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 1998

Actual date on which the first participant was enrolled.

PROTOCOL OUTLINE: Octreotide and/or diazoxide are discontinued on day 1, and fasting blood glucose is monitored. Patients receive test meals of Sustacal on days 3 and 4 and are assessed for insulin response. Beginning on day 5, patients are given recombinant human insulin-like growth factor I subcutaneously every 12 hours for a total of 3 doses. The first dose (on day 5) is given 30 minutes before a Sustacal challenge, the second dose is followed by a bedtime snack, and the third dose (on day 6) is followed by a supervised fast.

NCT00004825
Principal SponsorFDA Office of Orphan Products Development
Last updated: March 25, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 1 Months to 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Metabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease AttributesGlucose Metabolism DisordersEndocrine System DiseasesHyperinsulinismRare Diseases

Criteria

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of hyperinsulinism (i.e. evidence of fasting hypoglycemia with inadequate suppression of insulin, normal pituitary and adrenal function, and increased insulin action) Suboptimal control of blood sugar (i.e. inability to fast at least 10 hours with a blood sugar of 60 mg/dL or greater) No suspected insulinoma Must be currently managed on a regimen of diazoxide, octreotide and/or frequent feedings to control hypoglycemia --Prior/Concurrent Therapy-- See Disease Characteristics --Patient Characteristics-- Hematopoietic: No anemia or other concerns of blood volume depletion Renal: No renal dysfunction Other: No known malignancy No other major medical conditions

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers