Screening Adolescents for Type 2 Diabetes Mellitus in a Community Clinic

Diabetes Mellitus Clinical Trial

Official title:

Screening Adolescents for Type 2 Diabetes Mellitus in a Community Clinic

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00042042
• Other study ID #: NCRR-M01RR00030-0199
• Status: Recruiting
• Phase: N/A
• First received: July 22, 2002
• Last updated: June 23, 2005

Study information

• Verified date: July 2002
• Source: National Center for Research Resources (NCRR)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

This is a two part study. The first part is a diabetes screening study of 400 adolescent children who have a risk factor for type 2 diabetes to determine the prevalence of abnormal glucose metabolism in such patients. At the time of glucose screening all children will be given a dietary habit survey and two measures of depression/self-esteem to complete so that we may measure the correlation of depression and obesity and depression and abnormal glucose metabolism.

The second part tests the efficacy of a family based educational program in lowering fasting glucose in children who screen positive for type 2 DM, hyperinsulinemia, or impaired glucose tolerance. This educational assessment will be administered in an observational non-randomized, non-blinded fashion. The dietary habit survey and the measures of self-esteem and depression will aid us in creating this family based educational study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 19 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Family based educational program

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)	Diabetes Trust Fund, Duke University

Country where clinical trial is conducted

United States,