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Screening Adolescents for Type 2 Diabetes Mellitus in a Community Clinic

Primary Purpose

Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family based educational program
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Diabetes Mellitus

Eligibility Criteria

10 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria for screening will be patients who have one of the following: 120% 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)

Sites / Locations

  • Duke UniversityRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 22, 2002
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
Collaborators
Duke University, Diabetes Trust Fund
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1. Study Identification

Unique Protocol Identification Number
NCT00042042
Brief Title
Screening Adolescents for Type 2 Diabetes Mellitus in a Community Clinic
Official Title
Screening Adolescents for Type 2 Diabetes Mellitus in a Community Clinic
Study Type
Interventional

2. Study Status

Record Verification Date
July 2002
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Research Resources (NCRR)
Collaborators
Duke University, Diabetes Trust Fund

4. Oversight

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Family based educational program

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria for screening will be patients who have one of the following: 120% 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)
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Spratt, MD
Phone
919-684-4090
Email
sprat002@mc.duke.edu
First Name & Middle Initial & Last Name & Degree
Diana McNeill, MD
Phone
919-684-6841

12. IPD Sharing Statement

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Screening Adolescents for Type 2 Diabetes Mellitus in a Community Clinic

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