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

NCT ID: NCT00717483

Last Updated: 2016-07-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 108 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2010-05-31

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Type 1 diabetes

children with type 1 diabetes

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• T1DM
• 2-17 years old

Exclusion Criteria

• T2DM
• Known seizure disorder

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Rubina Heptulla, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rubina A Heptulla, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor (now Montefiore)

Locations

Baylor College of Medicine

Houston, Texas, United States

Texas Childrens Hospital

Houston, Texas, United States

Countries

United States

References

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. doi: 10.1016/s0022-3476(94)70190-3.

Reference Type: BACKGROUND

PMID: 8040759 (View on PubMed)

Hypoglycemia in the Diabetes Control and Complications Trial. The Diabetes Control and Complications Trial Research Group. Diabetes. 1997 Feb;46(2):271-86.

Reference Type: BACKGROUND

PMID: 9000705 (View on PubMed)

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. doi: 10.2337/diacare.27.10.2293.

Reference Type: BACKGROUND

PMID: 15451890 (View on PubMed)

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. doi: 10.1001/jama.287.19.2511.

Reference Type: BACKGROUND

PMID: 12020331 (View on PubMed)

Other Identifiers

H-23285

Identifier Type: -

Identifier Source: org_study_id