- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00042042
Screening Adolescents for Type 2 Diabetes Mellitus in a Community Clinic
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27710
- Recruiting
- Duke University
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Contact:
- Susan Spratt, MD
- Phone Number: 919-684-4090
- Email: sprat002@mc.duke.edu
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Contact:
- Diana McNeill, MD
- Phone Number: 919-684-6841
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Educational/Counseling/Training
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCRR-M01RR00030-0199
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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