Recruiting

Observational Study

Sponsor:

National Center for Research Resources (NCRR)

Code:

NCT00042042

Conditions

Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 10 - 19

Healthy Volunteers: Accepted

Interventions

Family based educational program

Study Details

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.

Conditions

Diabetes Mellitus

Study ID

NCT00042042

Status verified date

Jul, 2002

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 19

Healthy Volunteers: Accepted

Inclusion criteria for screening will be patients who have one of the following:

1. 120% of ideal body weight or BMI> 27
2. Weight greater than 75th percentile
3. Family history of type 2 diabetes in first or second degree relative
4. Acanthosis nigricans or skin tags as signs of insulin resistance
5. Symptoms of hyperglycemia (polyuria, polydipsia, polyphagia, or recurrent infections).
6. Symptoms or signs of PCOS (hyperandrogenism, hirsutism, irregular menses)

Study Design

Enrollment

400 participants

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Educational/Counseling/Training

Interventions and Outcome Measures

Interventions

Family based educational program

Central Contacts and Locations

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Diana McNeill, MD

919-684-6841

More Information

Sponsor

National Center for Research Resources (NCRR)

Last update posted

Jun 24, 2005

Last verified

Jul, 2002

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by National Center for Research Resources (NCRR) on 2005-06-24.