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

NCT00434772 | Completed Phase 2

• 1 other identifier: bisseliches-glucagon-ctil
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypoglycemia

Keywords

hypoglycemia; glucagon; neonatal; gestational diabetes; insulin; glyburide

Outcome Measures

Primary Outcomes (1)

• glucose

Secondary Outcomes (1)

• hospitalisation days

Interventions

glucagon DRUG

Eligibility Criteria

• Age: Up to 48 Hours
• Sex: all
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• concurrent medical problems
• symptomatic hypoglycemia
• glucose under 20 mg%

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Share Zedek Medical Center

Jerusalem, 91031, Israel

Location

MeSH Terms

Conditions

Hypoglycemia; Diabetes, Gestational; Insulin Resistance

Interventions

Glucagon

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Proglucagon; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Bisseliches Myriam, MD

  Shaare Zedek Medical Center - Jerusalem - Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 11, 2007
• First Posted: February 13, 2007
• Study Start: December 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: May 28, 2009

Record last verified: 2009-05

Locations

IL (1)