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

Completed

• Conditions: Type 1 Diabetes Mellitus

• Registration Number: NCT00717483
• Lead Sponsor: Baylor College of Medicine

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.

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 Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-16
• Study First Submitted QC: 2008-07-16
• Study First Posted: 2008-07-17
• Primary Completion: 2010-01
• Study Completion: 2010-05
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-19
• Last Update Posted: 2016-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• T1DM
• 2-17 years old

Exclusion Criteria

• T2DM
• Known seizure disorder

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Texas Childrens Hospital; 🇺🇸 Houston, Texas, United States