Screening Adolescents for Type 2 Diabetes Mellitus in a Community Clinic

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2002 by National Center for Research Resources (NCRR).
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Duke University
Diabetes Trust Fund
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00042042
First received: July 22, 2002
Last updated: June 23, 2005
Last verified: July 2002
  Purpose

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 Intervention
Diabetes Mellitus
Behavioral: Family based educational program

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: Screening Adolescents for Type 2 Diabetes Mellitus in a Community Clinic

Resource links provided by NLM:


Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment: 400
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.

  Eligibility

Ages Eligible for Study:   10 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042042

Locations
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
Duke University
Diabetes Trust Fund
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00042042     History of Changes
Other Study ID Numbers: NCRR-M01RR00030-0199
Study First Received: July 22, 2002
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on August 28, 2014