NCT00042042

Brief Summary

The purpose of this study is to evaluate the prevalence of Type 2 diabetes or impaired glucose tolerance in a subset of children 10-19 years of age in an inner city community clinic. The demographics of the clinic are 75% African American, 20% Hispanic, 5% other. African American and Hispanic patients have a higher prevalence of diabetes with significant morbidity, predominantly from microvascular and macrovascular disease. Obesity is commonly seen in patients with Type 2 diabetes and contributes to the underlying insulin resistance seen in the disease. Obesity is an increasing health problem among adolescents. Since Type 2 diabetes can be present for several years before diagnosis, it is worrisome that younger children will have undiagnosed Type 2 diabetes for years. This will increase the risk of earlier complications in these patients as young adults. We hypothesize that the occurrence of abnormal glucose metabolism in 400 children with either a history of obesity, family history of diabetes mellitus, or symptoms suggestive of diabetes mellitus will be higher than the general pediatric population. We believe that a family based educational program can reduce fasting plasma glucose.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2002

Completed
Last Updated

June 24, 2005

Status Verified

July 1, 2002

First QC Date

July 22, 2002

Last Update Submit

June 23, 2005

Conditions

Diabetes Mellitus

Interventions

Family based educational programBEHAVIORAL

Eligibility Criteria

Age10 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • % of ideal body weight or BMI\> 27
  • Weight greater than 75th percentile
  • Family history of type 2 diabetes in first or second degree relative
  • Acanthosis nigricans or skin tags as signs of insulin resistance
  • Symptoms of hyperglycemia (polyuria, polydipsia, polyphagia, or recurrent infections).
  • Symptoms or signs of PCOS (hyperandrogenism, hirsutism, irregular menses)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

July 22, 2002

First Posted

July 23, 2002

Last Updated

June 24, 2005

Record last verified: 2002-07

Locations

US(1)