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

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

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.

Type 1 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: BMI and Its Relationship to Hypoglycemic Seizures in Children With Insulin-requiring Diabetes

Resource links provided by NLM:

Further study details as provided by Baylor College of Medicine:

Enrollment: 108
Study Start Date: July 2008
Study Completion Date: May 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Type 1 diabetes
children with type 1 diabetes

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.

Ages Eligible for Study:   2 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Identifier: NCT00717483     History of Changes
Other Study ID Numbers: H-23285 
Study First Received: July 16, 2008
Last Updated: July 19, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
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 processed this record on October 21, 2016