BMI and Its Relationship to Hypoglycemic Seizures in Children With Insulin-Requiring Diabetes - Full Text View

Sponsored by:	Baylor College of Medicine
Information provided by:	Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00717483

Purpose

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
Type 1 Diabetes Mellitus

Genetics Home Reference related topics: pyridoxine-dependent epilepsy

MedlinePlus related topics: Diabetes Diabetes Type 1 Hypoglycemia Seizures

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Retrospective

Further study details as provided by Baylor College of Medicine:

Estimated Enrollment:	108
Study Start Date:	July 2008
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

Eligibility

Ages Eligible for Study:	2 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Subjects are patients with type 1 diabetes mellitus

Criteria

Inclusion Criteria:

T1DM
2-18 years old

Exclusion Criteria:

T2DM
Known seizure disorder

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717483

Contacts

Contact: Rubina A Heptulla, MD

832-822-3779

raheptul@texaschildrenshospital.org

Locations

United States, Texas
Baylor College of Medicine	Enrolling by invitation
Houston, Texas, United States, 77030
Texas Childrens Hospital	Recruiting
Houston, Texas, United States, 77030
Contact: Rubina A Heptulla, MD raheptul@texaschildrenshospital.org
Principal Investigator: Rubina A Heptulla, MD

Sponsors and Collaborators

Baylor College of Medicine

More Information

Publications:

[No authors listed] Effect of intensive diabetes treatment on the development and progression of long-term complications in adolescents with insulin-dependent diabetes mellitus: Diabetes Control and Complications Trial. Diabetes Control and Complications Trial Research Group. J Pediatr. 1994 Aug;125(2):177-88.

[No authors listed] Hypoglycemia in the Diabetes Control and Complications Trial. The Diabetes Control and Complications Trial Research Group. Diabetes. 1997 Feb;46(2):271-86.

Bulsara MK, Holman CD, Davis EA, Jones TW. The impact of a decade of changing treatment on rates of severe hypoglycemia in a population-based cohort of children with type 1 diabetes. Diabetes Care. 2004 Oct;27(10):2293-8.

Rewers A, Chase HP, Mackenzie T, Walravens P, Roback M, Rewers M, Hamman RF, Klingensmith G. Predictors of acute complications in children with type 1 diabetes. JAMA. 2002 May 15;287(19):2511-8.

Responsible Party:	Baylor College of Medicine ( Dr. Rubina Heptulla )
Study ID Numbers:	H-23285
Study First Received:	July 16, 2008
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00717483
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Seizures
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009