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BMI and Its Relationship to Hypoglycemic Seizures in Children With Insulin-requiring Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rubina Heptulla, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00717483
First received: July 16, 2008
Last updated: July 19, 2016
Last verified: July 2016

July 16, 2008
July 19, 2016
July 2008
January 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00717483 on ClinicalTrials.gov Archive Site
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BMI and Its Relationship to Hypoglycemic Seizures in Children With Insulin-requiring Diabetes
BMI and Its Relationship to Hypoglycemic Seizures in Children With Insulin-requiring Diabetes

The landmark study Diabetes Control and Complication Trial (DCCT) clearly showed that intensive insulin management delays the onset and progression of longterm complications in adolescents with type 1 diabetes mellitus (T1DM). The same clinic trial also showed increased rate of severe hypoglycemia which required assistance. The risks of severe hypoglycemia, defined as loss of consciousness or seizure associated with hypoglycemia, include lower HbA1C, younger age, higher insulin dose, male sex, lower parental socioeconomic status, non-Hispanic white ethnicity, longer duration of disease, the presence of psychiatric disorders, and underinsurance.

The purpose of this protocol is to explore the relationship between hypoglycemic seizures and BMI.

This is a retrospective study using questionnaire/survey/interview. We will give subjects a letter stating the purpose and describing the study. We will answer all questions they have about the study. Once the parents and patient verbally agree to participate in the study, we will proceed with the survey.
Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample
Subjects are patients with type 1 diabetes mellitus
Type 1 Diabetes Mellitus
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Type 1 diabetes
children with type 1 diabetes

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
May 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • T1DM
  • 2-17 years old

Exclusion Criteria:

  • T2DM
  • Known seizure disorder
Both
2 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00717483
H-23285
No
No
Not Provided
Rubina Heptulla, MD, Baylor College of Medicine
Baylor College of Medicine
Not Provided
Principal Investigator: Rubina A Heptulla, MD Baylor (now Montefiore)
Baylor College of Medicine
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP