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

This study has been completed.

Sponsor:

Information provided by:

Baylor College of Medicine

ClinicalTrials.gov Identifier:

NCT00717483

First received: July 16, 2008

Last updated: September 16, 2010

Last verified: September 2010

History of Changes

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

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Retrospective

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 1 Hypoglycemia Seizures

U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

Estimated 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)

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 17 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
2-17 years old

Exclusion Criteria:

T2DM
Known seizure disorder

Contacts and Locations

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

Locations

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

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:	Dr. Rubina Heptulla, Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00717483 History of Changes
Other Study ID Numbers:	H-23285
Study First Received:	July 16, 2008
Last Updated:	September 16, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases

Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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