CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 108 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00717483
NCT00717483N/ACompleted

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

Baylor College of Medicine·observational·Posted Jul 17, 2008·Updated Jul 20, 2016

In Brief

An observational study for Type 1 Diabetes Mellitus. Completed, enrolled 108 participants across 2 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 17, 2008
Enrollment StartJul 1, 2008
Primary CompletionJan 1, 2010
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.0 years ago