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Screening Adolescents for Type 2 Diabetes Mellitus in a Community Clinic

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ClinicalTrials.gov Identifier: NCT00042042
Recruitment Status : Unknown
Verified July 2002 by National Center for Research Resources (NCRR).
Recruitment status was:  Recruiting
First Posted : July 23, 2002
Last Update Posted : June 24, 2005
Information provided by:

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.

Condition or disease Intervention/treatment
Diabetes Mellitus Behavioral: Family based educational program

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: Screening Adolescents for Type 2 Diabetes Mellitus in a Community Clinic

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00042042

United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Susan Spratt, MD    919-684-4090    sprat002@mc.duke.edu   
Contact: Diana McNeill, MD    919-684-6841      
Sponsors and Collaborators
National Center for Research Resources (NCRR)
Duke University
Diabetes Trust Fund
More Information

ClinicalTrials.gov Identifier: NCT00042042     History of Changes
Other Study ID Numbers: NCRR-M01RR00030-0199
First Posted: July 23, 2002    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: July 2002

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases