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Screening Adolescents for Type 2 Diabetes Mellitus in a Community Clinic

NCT ID: NCT00042042

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

ECT

Blinding Strategy

NONE

Interventions

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Family based educational program

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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)
Minimum Eligible Age

10 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role collaborator

Diabetes Trust Fund

OTHER

Sponsor Role collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role lead

Locations

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Duke University

Durham, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Susan Spratt, MD

Role: primary

Diana McNeill, MD

Role: backup

Other Identifiers

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NCRR-M01RR00030-0199

Identifier Type: -

Identifier Source: org_study_id