Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042042
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2002-07-22
Brief Title:
Screening Adolescents for Type 2 Diabetes Mellitus in a Community Clinic
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
Screening Adolescents for Type 2 Diabetes Mellitus in a Community Clinic
Status:
UNKNOWN
Status Verified Date:
2002-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 depressionself-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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: