HypoglycemiaPhase 2NCT00434772
Glucagon in the Treatment of Hypoglycemia in Newborn Infants of Diabetic Mothers
A Phase 2 study testing glucagon in people with Hypoglycemia, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 48 hours
- Conditions the study is for
- Hypoglycemia
- What is being tested?
- glucagon
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Dec 2007to May 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 48 hours
- All sexes
- Child
Who may be able to join
- asymptomatic hypoglycemia
- infant of insulin treated diabetic mother
- AGA or LGA
- no other known medical problems
Who cannot join
- concurrent medical problems
- symptomatic hypoglycemia
- glucose under 20 mg%
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- glucagon
- Keywords
- hypoglycemia, glucagon, neonatal, gestational diabetes, insulin, glyburide
- Medical subject headings
- Hypoglycemia, Diabetes, Gestational, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucagonDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose
Secondary outcomes (1)
hospitalisation days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2007 (estimated)
- Study startDec 2007
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Bisseliches Myriam, MD, Principal investigator, Shaare Zedek Medical Center - Jerusalem - Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00434772
- Sponsor's protocol ID
- bisseliches-glucagon-ctil
- Status last verified
- May 2009
- First submitted
- 11 Feb 2007
- Last updated
- 28 May 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucagon in the Treatment of Hypoglycemia in Newborn Infants of Diabetic Mothers
- ClinicalTrials.gov ID
- NCT00434772
- Acronym / sponsor ID
- bisseliches-glucagon-ctil
- Conditions
- Hypoglycemia
- Keywords
- hypoglycemia, glucagon, neonatal, gestational diabetes, insulin, glyburide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 13 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Age groups
- Child
Key inclusion criteria (4 listed)
- asymptomatic hypoglycemia
- infant of insulin treated diabetic mother
- AGA or LGA
- no other known medical problems
Key exclusion criteria (3 listed)
- concurrent medical problems
- symptomatic hypoglycemia
- glucose under 20 mg%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glucagon | Drug | – |
Primary outcome
glucose
1 secondary outcome
hospitalisation days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bisseliches Myriam, MD principal investigator
Shaare Zedek Medical Center - Jerusalem - Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing glucagon in people with Hypoglycemia, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glucose. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2009.