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

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ClinicalTrials.gov Identifier: NCT00717483
Recruitment Status : Completed
First Posted : July 17, 2008
Last Update Posted : July 20, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.

Condition or disease
Type 1 Diabetes Mellitus

Detailed Description:
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.

Study Design

Study Type : Observational
Actual Enrollment : 108 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: BMI and Its Relationship to Hypoglycemic Seizures in Children With Insulin-requiring Diabetes
Study Start Date : July 2008
Primary Completion Date : January 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Type 1 diabetes
children with type 1 diabetes

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects are patients with type 1 diabetes mellitus

Inclusion Criteria:

  • T1DM
  • 2-17 years old

Exclusion Criteria:

  • T2DM
  • Known seizure disorder
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00717483

United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Texas Childrens Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Principal Investigator: Rubina A Heptulla, MD Baylor (now Montefiore)
More Information

Responsible Party: Rubina Heptulla, MD, Principal Investigator, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00717483     History of Changes
Other Study ID Numbers: H-23285
First Posted: July 17, 2008    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Hypoglycemic Agents
Physiological Effects of Drugs