Full Text View
Tabular View
No Study Results Posted
Related Studies
Screening Adolescents for Type 2 Diabetes Mellitus in a Community Clinic
This study is currently recruiting participants.
Study NCT00042042   Information provided by National Center for Research Resources (NCRR)
First Received: July 22, 2002   Last Updated: June 23, 2005   History of Changes

July 22, 2002
June 23, 2005
 
 
 
 
Complete list of historical versions of study NCT00042042 on ClinicalTrials.gov Archive Site
 
 
 
Screening Adolescents for Type 2 Diabetes Mellitus in a Community Clinic
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.

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.

 
Interventional
Educational/Counseling/Training, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Diabetes Mellitus
Behavioral: Family based educational program
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
400
 
 

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)
Both
10 Years to 19 Years
Yes
 
United States
 
NCT00042042
 
NCRR-M01RR00030-0199
National Center for Research Resources (NCRR)
  • Duke University
  • Diabetes Trust Fund
 
National Center for Research Resources (NCRR)
July 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP