Glucagon in the Treatment of Hypoglycemia in Newborn Infants of Diabetic Mothers

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Glucagon in the Treatment of Hypoglycemia in Newborn Infants of Diabetic Mothers

This study is currently recruiting participants.
Verified by Shaare Zedek Medical Center, April 2008

Sponsored by: Shaare Zedek Medical Center

Information provided by: Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00434772

Purpose
Thesis Infants of diabetic mothers are at high risk to develop hypoglycemia after birth.

After birth, glucose and ketone bodies are the main substrates of brain energy. Under normal condition, the adrenergic response seen immediately after birth suppresses insulin release and stimulates glucagon secretion which enhances gluconeogenesis and ketogenesis.

An inversion of the insulin/glucagon ratio is seen soon after birth as a normal, physiologic phenomenon. Consequently, a post delivery glucose nadir is reached between 30 to 90 minutes after birth, followed by a spontaneous recovery before 3-4 hours of age.

In infants of diabetic mothers, this inversion of the ratio is postponed and a more profound and sustained hypoglycemia is seen.

Early feeding is of great importance to diminish the severity and incidence of hypoglycemia. But, if despite an appropriate calorie intake, low levels of sugar are seen, an intravenous infusion of glucose should be commenced. In case that IV glucose is not effective or can't be supplied immediately, intramuscular glucagon is a therapeutic alternative.

We hypothesize that a single intramuscular injection of glucagon together with the appropriate oral intake of nutrients is a safe and an effective alternative to the IV infusion of glucose alone in the treatment of hypoglycemia in term infants of diabetic mothers.

Methods Appropriately grown or large for date, term infants of insulin treated diabetic mothers, with no other known medical problems, are potential candidates for our study.

Hypoglycemia will be defined as serum glucose level lower than 45 mg%. Infants of diabetic mothers will arrive to the nursery and immediately receive early feeding before 30 minutes of life. At that time, glucose will be checked. If glucose level is lower than 45 mg%, treatment with IV glucose or IM glucagon will be initiated. Glucose will be checked every hour for 4 hours and then every 3 hours (before each meal) for the next 20 hours.

In case blood glucose level is lower than 20 mg% or falls below 45 mg% despite glucagon treatment, IV glucose will immediately be instituted.

Our aim is to check that IM Glucagon is as good as IV glucose in the treatment of hypoglycemia in infants of diabetic mothers. We will compare glucose levels after treatment with IV glucose and IM glucagon, the time till normalization of glucose and full feeding is achieved and the number of hospitalization days in both groups.

Condition Intervention Phase
Hypoglycemia
Drug: glucagon
Phase II

MedlinePlus related topics: Hypoglycemia

Drug Information available for: Glucagon

U.S. FDA Resources

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment

Official Title: Glucagon in the Treatment of Hypoglycemia in Newborn Infants of Diabetic Mothers

Further study details as provided by Shaare Zedek Medical Center:

Study Start Date: December 2007

Eligibility
Ages Eligible for Study: up to 48 Hours
Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

asymptomatic hypoglycemia
infant of insulin treated diabetic mother
AGA or LGA
no other known medical problems
Exclusion Criteria:

concurrent medical problems
symptomatic hypoglycemia
glucose under 20 mg%
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434772

Contacts

Contact: Cathy Hammerman, MD (=972-2) 666-6238 cathy@cc.huji.ac.il

Locations

Israel
Share Zedek Medical Center Recruiting
Jerusalem, Israel, 91031
Principal Investigator: Myriam Bisseliches, MD
Sub-Investigator: Cathy Hammerman, MD

Sponsors and Collaborators

Shaare Zedek Medical Center

Investigators

Principal Investigator: Bisseliches Myriam, MD Shaare Zedek Medical Center - Jerusalem - Israel

More Information

Study ID Numbers: bisseliches-glucagon-ctil
First Received: February 11, 2007
Last Updated: April 28, 2008
ClinicalTrials.gov Identifier: NCT00434772
Health Authority: Israel: Ethics Commission