SeizuresNCT00279851
Blood Sugars in Children With Idiopathic Seizures.
An observational study of Seizures and Hypoglycemia, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
The purpose of this study is to determine if there is a significant percentage of children with the diagnosis of idiopathic seizures who have undiagnosed or unrecognized hypoglycemia (low blood sugar). Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Seizures, Hypoglycemia, Hyperammonemia
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Feb 2007
- Phase
- Observational
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients with idiopathic seizure disorders under age 18 years of age.
Who may be able to join
- The inclusion criteria will be patients with idiopathic seizure disorders.
- The age range will be from birth to 17 years of age.
- Study subjects may be on anti-convulsants; the study does not alter current drug therapy.
Who cannot join
- The exclusion criteria includes patients with known causes of seizure disorders, including those with an underlying risk factor predisposing them to seizures. The risk factors are:
- congenital causes (CNS malformation, cerebral palsy)
- CNS infection toxic/known metabolic abnormality
- CNS neoplasm perinatal insults (birth trauma, asphyxia/hypoxia),
- traumatic
- All others who have an anatomic or known biochemical lesion.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
About this study
Official title: Prevalence of Hypoglycemia and/or Hyperinsulinism/Hyperammonemia Syndrome in Patients With Idiopathic Seizures.
The purpose of this study is to determine if there is a significant percentage of children with the diagnosis of idiopathic seizures who have undiagnosed or unrecognized hypoglycemia (low blood sugar).
Read the detailed description
Convulsive disorders are among the most frequently occurring neurologic conditions in children. Idiopathic seizures are the most common (67.6%) type of seizure seen in the 0-15 year age group. The highest incidence is in the first year of life. In the United States, 5 percent of individuals experience a seizure of some type by the age of 20.
Seizures have multiple etiologies. These include hypoglycemia, congenital causes, toxic/metabolic causes, infection, neoplasm, perinatal causes, and trauma. The medical evaluation often includes blood work, imaging of the brain, and performing an electroencephalogram. Currently, there is no consensus as to the work-up of children presenting with unprovoked seizures.
Hypoglycemia presents with a wide spectrum of symptoms and severity. In children, hypoglycemia can lead to seizures and coma. In neonates and infants, however, the symptoms are even more varied and nonspecific. They can include cyanotic spells, apnea, respiratory distress, refusal to feed, and myoclonic jerks. The varied symptoms of hypoglycemia make the disorder difficult to diagnose.
The study will have parents checking blood sugars for 14 days and a one time ammonia level. Blood sugar checks will be first thing in the morning and one hour after a meal. If the study identifies a subset of patients with idiopathic seizures who have hypoglycemia, this finding may have implications for future glucose screening recommendations.
- Conditions
- Seizures, Hypoglycemia, Hyperammonemia
- Keywords
- idiopathic seizure, hypoglycemia, hyperammonemia/hyperinsulinism syndrome
- Medical subject headings
- Seizures, Hypoglycemia, Hyperammonemia, Hyperinsulinemic hypoglycemia, familial, 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2006 (estimated)
- Study startFeb 2006
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for SeizuresStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chetanbabu M Patel, MD, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279851
- Sponsor's protocol ID
- 05046
- Status last verified
- Jan 2021
- First submitted
- 18 Jan 2006
- Last updated
- 6 Jan 2021
- Results posted
- No
Publications
Hsu BY, Kelly A, Thornton PS, Greenberg CR, Dilling LA, Stanley CA. Protein-sensitive and fasting hypoglycemia in children with the hyperinsulinism/hyperammonemia syndrome. J Pediatr. 2001 Mar;138(3):383-9. doi: 10.1067/mpd.2001.111818.
PubMed 11241047Hauser WA. The prevalence and incidence of convulsive disorders in children. Epilepsia. 1994;35 Suppl 2:S1-6. doi: 10.1111/j.1528-1157.1994.tb05932.x.
PubMed 8275976Sperling MA, Menon RK. Differential diagnosis and management of neonatal hypoglycemia. Pediatr Clin North Am. 2004 Jun;51(3):703-23, x. doi: 10.1016/j.pcl.2004.01.014.
PubMed 15157593Vilke GM, Castillo EM, Ray LU, Murrin PA, Chan TC. Evaluation of pediatric glucose monitoring and hypoglycemic therapy in the field. Pediatr Emerg Care. 2005 Jan;21(1):1-5. doi: 10.1097/01.pec.0000150980.94571.10.
PubMed 15643315Valencia I, Sklar E, Blanco F, Lipsky C, Pradell L, Joffe M, Legido A. The role of routine serum laboratory tests in children presenting to the emergency department with unprovoked seizures. Clin Pediatr (Phila). 2003 Jul-Aug;42(6):511-7. doi: 10.1177/000992280304200605.
PubMed 12921452Hirtz D, Ashwal S, Berg A, Bettis D, Camfield C, Camfield P, Crumrine P, Elterman R, Schneider S, Shinnar S. Practice parameter: evaluating a first nonfebrile seizure in children: report of the quality standards subcommittee of the American Academy of Neurology, The Child Neurology Society, and The American Epilepsy Society. Neurology. 2000 Sep 12;55(5):616-23. doi: 10.1212/wnl.55.5.616.
PubMed 10980722Raizen DM, Brooks-Kayal A, Steinkrauss L, Tennekoon GI, Stanley CA, Kelly A. Central nervous system hyperexcitability associated with glutamate dehydrogenase gain of function mutations. J Pediatr. 2005 Mar;146(3):388-94. doi: 10.1016/j.jpeds.2004.10.040.
PubMed 15756227Hauser WA. Seizure disorders: the changes with age. Epilepsia. 1992;33 Suppl 4:S6-14. doi: 10.1111/j.1528-1157.1992.tb06222.x.
PubMed 1425495Melegh B, Pap M, Morava E, Molnar D, Dani M, Kurucz J. Carnitine-dependent changes of metabolic fuel consumption during long-term treatment with valproic acid. J Pediatr. 1994 Aug;125(2):317-21. doi: 10.1016/s0022-3476(94)70218-7.
PubMed 8040784Nishida N, Sugimoto T, Araki A, Woo M, Sakane Y, Kobayashi Y. Carnitine metabolism in valproate-treated rats: the effect of L-carnitine supplementation. Pediatr Res. 1987 Nov;22(5):500-3. doi: 10.1203/00006450-198711000-00003.
PubMed 3120144al-Hosani H, Salah M, Saade D, Osman H, al-Zahid J. United Arab Emirates National Newborn Screening Programme: an evaluation 1998-2000. East Mediterr Health J. 2003 May;9(3):324-32.
PubMed 15751925Schweitzer-Krantz S. Early diagnosis of inherited metabolic disorders towards improving outcome: the controversial issue of galactosaemia. Eur J Pediatr. 2003 Dec;162 Suppl 1:S50-3. doi: 10.1007/s00431-003-1352-2. Epub 2003 Nov 12.
PubMed 14614623
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Hypoglycemia and/or Hyperinsulinism/Hyperammonemia Syndrome in Patients With Idiopathic Seizures.
- ClinicalTrials.gov ID
- NCT00279851
- Acronym / sponsor ID
- 05046
- Conditions
- Seizures, Hypoglycemia, Hyperammonemia
- Keywords
- idiopathic seizure, hypoglycemia, hyperammonemia/hyperinsulinism syndrome
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Feb 2006 (actual)
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 20 Jan 2006 (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.
The purpose of this study is to determine if there is a significant percentage of children with the diagnosis of idiopathic seizures who have undiagnosed or unrecognized hypoglycemia (low blood sugar).
Detailed description
Convulsive disorders are among the most frequently occurring neurologic conditions in children. Idiopathic seizures are the most common (67.6%) type of seizure seen in the 0-15 year age group. The highest incidence is in the first year of life. In the United States, 5 percent of individuals experience a seizure of some type by the age of 20.
Seizures have multiple etiologies. These include hypoglycemia, congenital causes, toxic/metabolic causes, infection, neoplasm, perinatal causes, and trauma. The medical evaluation often includes blood work, imaging of the brain, and performing an electroencephalogram. Currently, there is no consensus as to the work-up of children presenting with unprovoked seizures.
Hypoglycemia presents with a wide spectrum of symptoms and severity. In children, hypoglycemia can lead to seizures and coma. In neonates and infants, however, the symptoms are even more varied and nonspecific. They can include cyanotic spells, apnea, respiratory distress, refusal to feed, and myoclonic jerks. The varied symptoms of hypoglycemia make the disorder difficult to diagnose.
The study will have parents checking blood sugars for 14 days and a one time ammonia level. Blood sugar checks will be first thing in the morning and one hour after a meal. If the study identifies a subset of patients with idiopathic seizures who have hypoglycemia, this finding may have implications for future glucose screening recommendations.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients with idiopathic seizure disorders under age 18 years of age.
Key inclusion criteria (3 listed)
- The inclusion criteria will be patients with idiopathic seizure disorders.
- The age range will be from birth to 17 years of age.
- Study subjects may be on anti-convulsants; the study does not alter current drug therapy.
Key exclusion criteria (6 listed)
- The exclusion criteria includes patients with known causes of seizure disorders, including those with an underlying risk factor predisposing them to seizures. The risk factors are:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Background: PubMed 11241047Hsu BY, Kelly A, Thornton PS, Greenberg CR, Dilling LA, Stanley CA. Protein-sensitive and fasting hypoglycemia in children with the hyperinsulinism/hyperammonemia syndrome. J Pediatr. 2001 Mar;138(3):383-9. doi: 10.1067/mpd.2001.111818.
- Background: PubMed 8275976Hauser WA. The prevalence and incidence of convulsive disorders in children. Epilepsia. 1994;35 Suppl 2:S1-6. doi: 10.1111/j.1528-1157.1994.tb05932.x.
- Background: PubMed 15157593Sperling MA, Menon RK. Differential diagnosis and management of neonatal hypoglycemia. Pediatr Clin North Am. 2004 Jun;51(3):703-23, x. doi: 10.1016/j.pcl.2004.01.014.
- Background: PubMed 15643315Vilke GM, Castillo EM, Ray LU, Murrin PA, Chan TC. Evaluation of pediatric glucose monitoring and hypoglycemic therapy in the field. Pediatr Emerg Care. 2005 Jan;21(1):1-5. doi: 10.1097/01.pec.0000150980.94571.10.
- Background: PubMed 12921452Valencia I, Sklar E, Blanco F, Lipsky C, Pradell L, Joffe M, Legido A. The role of routine serum laboratory tests in children presenting to the emergency department with unprovoked seizures. Clin Pediatr (Phila). 2003 Jul-Aug;42(6):511-7. doi: 10.1177/000992280304200605.
- Background: PubMed 10980722Hirtz D, Ashwal S, Berg A, Bettis D, Camfield C, Camfield P, Crumrine P, Elterman R, Schneider S, Shinnar S. Practice parameter: evaluating a first nonfebrile seizure in children: report of the quality standards subcommittee of the American Academy of Neurology, The Child Neurology Society, and The American Epilepsy Society. Neurology. 2000 Sep 12;55(5):616-23. doi: 10.1212/wnl.55.5.616.
- Background: PubMed 15756227Raizen DM, Brooks-Kayal A, Steinkrauss L, Tennekoon GI, Stanley CA, Kelly A. Central nervous system hyperexcitability associated with glutamate dehydrogenase gain of function mutations. J Pediatr. 2005 Mar;146(3):388-94. doi: 10.1016/j.jpeds.2004.10.040.
- Background: PubMed 1425495Hauser WA. Seizure disorders: the changes with age. Epilepsia. 1992;33 Suppl 4:S6-14. doi: 10.1111/j.1528-1157.1992.tb06222.x.
- Background: PubMed 8040784Melegh B, Pap M, Morava E, Molnar D, Dani M, Kurucz J. Carnitine-dependent changes of metabolic fuel consumption during long-term treatment with valproic acid. J Pediatr. 1994 Aug;125(2):317-21. doi: 10.1016/s0022-3476(94)70218-7.
- Background: PubMed 3120144Nishida N, Sugimoto T, Araki A, Woo M, Sakane Y, Kobayashi Y. Carnitine metabolism in valproate-treated rats: the effect of L-carnitine supplementation. Pediatr Res. 1987 Nov;22(5):500-3. doi: 10.1203/00006450-198711000-00003.
- Background: PubMed 15751925al-Hosani H, Salah M, Saade D, Osman H, al-Zahid J. United Arab Emirates National Newborn Screening Programme: an evaluation 1998-2000. East Mediterr Health J. 2003 May;9(3):324-32.
- Background: PubMed 14614623Schweitzer-Krantz S. Early diagnosis of inherited metabolic disorders towards improving outcome: the controversial issue of galactosaemia. Eur J Pediatr. 2003 Dec;162 Suppl 1:S50-3. doi: 10.1007/s00431-003-1352-2. Epub 2003 Nov 12.
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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.
Chetanbabu M Patel, MD principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Seizures and Hypoglycemia, run by Children's Mercy Hospital Kansas City at 1 site in United States.
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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 6 Jan 2021. 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 United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00279851, which also lists 12 linked publications.
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 6 Jan 2021.