Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00007098
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2000-12-07
Brief Title:
Influence of Insulin on BP Change During Adolescence
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
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:
To define the relation of insulin resistance during childhood and adolescence to the development of the insulin resistance syndrome in young adulthood
Detailed Description:
BACKGROUND
The insulin resistance syndrome IRS is associated with a considerable increase in the risk of cardiovascular disease in adults The disorder most likely is inherited to some degree with onset in childhood and early adolescence The IRS is best defined by quantitative data from euglycemic insulin clamp studies The investigators have developed a unique data base in children and by continuing repeated studies and follow-up in early adulthood together with studies in parents and siblings this study should provide important insight into the occurrence and progression of cardiovascular disease in later life
DESIGN NARRATIVE
The study is designed to 1 define the relation of insulin resistance during childhood and adolescence to the development of insulin resistance syndrome hypertension dyslipidemia obesity and insulin resistance in young adulthood and 2 define the relation of insulin resistance within families The original cohort consists of 357 children who have had two euglycemic insulin clamp studies at mean ages 13 and 15 years The specific aims are to 1 repeat anthropometric and blood pressure measurements at mean ages 18 19 and 20 and obtain insulin clamps lipid levels echocardiograms and DEXA at mean age 21 in the children and 2 obtain the measurements blood and DNA samples echocardiogram and insulin clamp in the parents and siblings of the children Statistical genetics methods are used to estimate heritability and genetic correlations among the insulin resistance syndrome traits These data address the hypotheses that 1 insulin resistance in childhood predicts insulin resistance and cardiovascular risk factors in young adulthood 2 insulin resistance in parents is associated with insulin resistance and cardiovascular risk factors in their children 3 in fat children BMI and insulin resistance at mean age 13 predicts cardiovascular risk but in thin children only insulin resistance is a similar predictor 4 insulin resistance has significant heritability and 5 there are significant genetic correlations between insulin resistance and the insulin resistance traits At least 300 of the original cohort of 357 who have had two euglycemic insulin clamps continue on in the study The study continues through July 2008
The insulin resistance syndrome IRS is associated with a considerable increase in the risk of cardiovascular disease in adults The disorder most likely is inherited to some degree with onset in childhood and early adolescence The IRS is best defined by quantitative data from euglycemic insulin clamp studies The investigators have developed a unique data base in children and by continuing repeated studies and follow-up in early adulthood together with studies in parents and siblings this study should provide important insight into the occurrence and progression of cardiovascular disease in later life
DESIGN NARRATIVE
The study is designed to 1 define the relation of insulin resistance during childhood and adolescence to the development of insulin resistance syndrome hypertension dyslipidemia obesity and insulin resistance in young adulthood and 2 define the relation of insulin resistance within families The original cohort consists of 357 children who have had two euglycemic insulin clamp studies at mean ages 13 and 15 years The specific aims are to 1 repeat anthropometric and blood pressure measurements at mean ages 18 19 and 20 and obtain insulin clamps lipid levels echocardiograms and DEXA at mean age 21 in the children and 2 obtain the measurements blood and DNA samples echocardiogram and insulin clamp in the parents and siblings of the children Statistical genetics methods are used to estimate heritability and genetic correlations among the insulin resistance syndrome traits These data address the hypotheses that 1 insulin resistance in childhood predicts insulin resistance and cardiovascular risk factors in young adulthood 2 insulin resistance in parents is associated with insulin resistance and cardiovascular risk factors in their children 3 in fat children BMI and insulin resistance at mean age 13 predicts cardiovascular risk but in thin children only insulin resistance is a similar predictor 4 insulin resistance has significant heritability and 5 there are significant genetic correlations between insulin resistance and the insulin resistance traits At least 300 of the original cohort of 357 who have had two euglycemic insulin clamps continue on in the study The study continues through July 2008
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None