NCT00004572

Brief Summary

The two major types of diabetes are type 1 and type 2 diabetes. Although most patients with type 2 diabetes are older than age 40, type 2 diabetes has been reported with increasing frequency among patients under the age of 20. This form of diabetes has been called type 2 diabetes of youth, abbreviated type 2Y. Little is known about the etiology of type 2Y; however, clinicians believe that it occurs most commonly in obese children of particular ethnic groups. A positive family history appears to be one major risk factor for developing type 2Y diabetes. The individual contribution of ethnicity, obesity, and genetics to type 2Y have yet to be elucidated. There is no consensus regarding treatment with type 2Y diabetes. Observation of our Hispanic patients in the Houston area reveals a large number with type 2Y. The major purpose of this study is to examine the genetic and environmental risk factors such as family history, ethnicity, and obesity in Hispanic children with type 2Y diabetes. SPECIFIC AIMS: 1) To examine the genetic and environmental risk factors and clinical signs associated with type 1 diabetes and type 2 diabetes of youth. 2) To compare the efficacy of the treatment modalities, insulin and oral agents, in type 2Y patients. METHODS: We will undertake a retrospective case study, to include a review of hypothesized risk factors in all the medical records of pediatric diabetes patients seen at University of Texas. We anticipate that approximately 200 patients with type 1 diabetes and 30 patients with type 2Y diabetes will be identified. A Sustacal challenge test will be done in patients with a suspected diagnosis of type 2Y in order to confirm the clinical diagnosis. Parents will be contacted by phone for a detailed pedigree intake. Type 1 and type 2Y patients will be compared for each of the studied features. A retrospective review of diabetes type 2 therapies used in type 2Y patients will be undertaken through further examination of the medical records in order to compare insulin treatment to oral agents. We will also test a subset of the patients for the gene identified in adult Hispanics with type 2 diabetes.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 17, 2000

Completed
Last Updated

June 24, 2005

Status Verified

April 1, 2000

First QC Date

February 16, 2000

Last Update Submit

June 23, 2005

Conditions

Keywords

Type 2 Diabetes

Interventions

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Approximately 30 pediatric patients (ages 10-18) believed to have a diagnosis of type 2Y. Each subject must have been diagnosed for at least one year.

You may not qualify if:

  • Patients over the age of 18 or under the age of 10
  • Patients in whom intellectual functioning is impaired sufficiently to interfere with the understanding of the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Sponsor Type
NIH

Study Record Dates

First Submitted

February 16, 2000

First Posted

February 17, 2000

Last Updated

June 24, 2005

Record last verified: 2000-04