Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00443755
Status:
COMPLETED
Last Update Posted:
2013-10-31
First Post:
2007-02-26
Brief Title:
Effect of Insulin Sensitizer Therapy on Atherothrombotic and Inflammatory Profiles Associated With Insulin Resistance
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Effect of Insulin Sensitizer Therapy on Atherothrombotic and Inflammatory Profiles Associated With Insulin Resistance
Status:
COMPLETED
Status Verified Date:
2013-10
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:
The objective of this study is to determine whether targeted pharmacological improvement of insulin sensitivity will normalize the associated elevations of thrombotic and inflammatory cardiovascular disease CVD biomarkers in individuals with insulin resistance
Detailed Description:
Individuals with diabetes mellitus DM are disproportionately affected by atherothrombotic disorders including cardiovascular cerebrovascular and peripheral vascular diseases Atherothrombotic disease risk and mortality are also increased with metabolic syndrome a constellation of risk factors present in more than 34 of adults even in absence of diabetes Yet large clinical trials of diabetes therapies have shown that conventional cardiovascular disease CVD risk factors specifically hyperglycemia and hypertension do not fully account for increased CVD risk associated with DM
There may be an etiologic link among insulin resistance inflammation and thrombotic events This study seeks to determine if certain two diabetes medications the insulin sensitizing medications will affect certain biomarkers or laboratory tests for CVD in individuals with untreated DM or impaired fasting glucose
Patients will be screened for inclusion into this this double-blinded randomized placebo-controlled study If inclusion criteria are met and exclusion criteria not met patients will be enrolled in the the study Half of the subjects will be randomized like the flip of a coin to take two insulin sensitizing anti-diabetic drugs pioglitazone Actos and metformin Glucophage taken together for three months and the other half of the subjects will take corresponding placebo dummy tablets
Laboratory measurements will be obtained on the mornings following the two in-patient overnight stays in the Mayo Clinic Clinical Research Unit The first stay will be at baseline and the second stay will be 3 months after baseline Insulin sensitivity will be measured in the morning following a standardized meal the preceding night and after an overnight fast
The changes from baseline to 3 months in insulin sensitivity glycemic control the lipid profile thrombotic markers and inflammatory markers will be determined and compared between the two arms of the study placebo versus insulin sensitizing drugs
There may be an etiologic link among insulin resistance inflammation and thrombotic events This study seeks to determine if certain two diabetes medications the insulin sensitizing medications will affect certain biomarkers or laboratory tests for CVD in individuals with untreated DM or impaired fasting glucose
Patients will be screened for inclusion into this this double-blinded randomized placebo-controlled study If inclusion criteria are met and exclusion criteria not met patients will be enrolled in the the study Half of the subjects will be randomized like the flip of a coin to take two insulin sensitizing anti-diabetic drugs pioglitazone Actos and metformin Glucophage taken together for three months and the other half of the subjects will take corresponding placebo dummy tablets
Laboratory measurements will be obtained on the mornings following the two in-patient overnight stays in the Mayo Clinic Clinical Research Unit The first stay will be at baseline and the second stay will be 3 months after baseline Insulin sensitivity will be measured in the morning following a standardized meal the preceding night and after an overnight fast
The changes from baseline to 3 months in insulin sensitivity glycemic control the lipid profile thrombotic markers and inflammatory markers will be determined and compared between the two arms of the study placebo versus insulin sensitizing drugs
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UL1RR024150 | NIH | None | httpsreporternihgovquickSearchUL1RR024150 |
| R01DK041973 | NIH | None | None |
| KL2RR024151 | NIH | None | None |