Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00139477
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2005-08-29
Brief Title:
Study of Serum Markers for Cardiovascular Risk in Obese Youth and Impact of Lifestyle and Medication Intervention
Sponsor:
Nemours Childrens Clinic
Organization:
Nemours Childrens Clinic
Study Overview
Official Title:
Understanding the Effects of Therapeutic Intervention on Cardiovascular Risk Markers Insulin Resistance and Intra-Hepatic Fat Contents in Obese Children at High Risk for the Metabolic Syndrome
Status:
COMPLETED
Status Verified Date:
2012-10
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:
In Protocol 2 we will select 30 obese pubertal and 30 obese prepubertal subjects with an abnormal cytokine profile ie fibrinogen andor hsCRP concentration greater than or equal to 2 Standard Deviations SD above the mean established in our lab for lean controls in Protocol 1 They will be randomly assigned to either lifestyle intervention dietexercise or dietexercise plus metformin for 6 months After the 6 month evaluation the subjects will cross over the treatment arms ie those that were doing dietexercise intervention only will add metformin those that were doing the dietexercise plus metformin will discontinue the metformin and continue with dietexercise changes only Intrahepatic fat contents will be measured as well
The investigators hypothesize that obese children in these age groups will have increased cardiovascular risk related to their obese state before reaching the currently defined criteria of metabolic syndrome
The investigators hypothesize that these cardiovascular risks can be reduced with lifestyle and drug interventions
The investigators hypothesize that obese children in these age groups will have increased cardiovascular risk related to their obese state before reaching the currently defined criteria of metabolic syndrome
The investigators hypothesize that these cardiovascular risks can be reduced with lifestyle and drug interventions
Detailed Description:
None
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