Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006071
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-07-21
Brief Title:
Effects of Rosiglitazone on Blood Vessels in Patients With High Blood Pressure and High Cholesterol
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Effects of Rosiglitazone on Endothelium-Dependent Vasodilation and on Endothelin Activity in Patients With Essential Hypertension and in Patients With Hypercholesterolemia
Status:
COMPLETED
Status Verified Date:
2000-07
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:
Cells in the lining of blood vessels produce various substances that cause the vessels to dilate relax and constrict tighten thereby regulating blood flow In patients with high blood pressure and high cholesterol the blood vessels do not dilate properly This study will investigate the effects of rosiglitazone-a drug used to improve the action of insulin in diabetic patients-on blood flow by examining its effects on endothelin a substance that causes vessel constriction and other substances produced by the vessel-lining cells
Adults with blood pressure recordings of 14090 mmHg or higher on at least three separate days or with a blood cholesterol level of at least 240 mgdl may be eligible for this study Candidates will be screened with a medical history and physical examination blood pressure recordings blood and urine tests
This crossover study involves two separate treatment periods that is participants will take either rosiglitazone or placebo an inactive look-alike pill once a day for 8 weeks then no drug for 4 weeks and then the alternative treatment for the next 8 weeks Patients will continue to take their high blood pressure medicines during the first 6 weeks of each treatment period They will stop the medication 2 weeks before the following procedures which are done at the end of each 8-week treatment period
Strain gauge plethysmography-A small catheter is placed through a needle into an artery at the bend of the arm for measuring blood pressure and drawing blood samples during the study Pressure cuffs are placed on the wrist and upper arm and a strain gauge a rubber band device is placed around the forearm to measure forearm blood flow When the cuffs are inflated blood flows into the arm stretching the strain gauge at a rate proportional to the flow and the measurement is recorded
Small doses of four drugs-acetylcholine bradykinin sodium nitroprusside and BQ-123-are given through the catheter Acetylcholine slows the heart rate Bradykinin stimulates the release of a substance that causes blood vessels to dilate and can lower blood pressure Sodium nitroprusside causes blood vessels to dilate and is used to treat high blood pressure and heart failure BQ-123 blocks the blood vessel-constricting activity of endothelin
Brachial ultrasound reactivity study-A baseline ultrasound image picture produced using sound waves of the brachial artery artery located at the bend of the arm is taken and blood flow measurements are recorded Then a pressure cuff is placed around the upper forearm inflated for 5 minutes to stop blood flow to the forearm and then released Images of the artery and flow measurements are repeated After a 15-minute rest new baseline images are taken and flow measurements obtained A small amount of nitroglycerin is then sprayed under the tongue and after 3 minutes blood flow measurements and brachial artery images are recorded once more
Adults with blood pressure recordings of 14090 mmHg or higher on at least three separate days or with a blood cholesterol level of at least 240 mgdl may be eligible for this study Candidates will be screened with a medical history and physical examination blood pressure recordings blood and urine tests
This crossover study involves two separate treatment periods that is participants will take either rosiglitazone or placebo an inactive look-alike pill once a day for 8 weeks then no drug for 4 weeks and then the alternative treatment for the next 8 weeks Patients will continue to take their high blood pressure medicines during the first 6 weeks of each treatment period They will stop the medication 2 weeks before the following procedures which are done at the end of each 8-week treatment period
Strain gauge plethysmography-A small catheter is placed through a needle into an artery at the bend of the arm for measuring blood pressure and drawing blood samples during the study Pressure cuffs are placed on the wrist and upper arm and a strain gauge a rubber band device is placed around the forearm to measure forearm blood flow When the cuffs are inflated blood flows into the arm stretching the strain gauge at a rate proportional to the flow and the measurement is recorded
Small doses of four drugs-acetylcholine bradykinin sodium nitroprusside and BQ-123-are given through the catheter Acetylcholine slows the heart rate Bradykinin stimulates the release of a substance that causes blood vessels to dilate and can lower blood pressure Sodium nitroprusside causes blood vessels to dilate and is used to treat high blood pressure and heart failure BQ-123 blocks the blood vessel-constricting activity of endothelin
Brachial ultrasound reactivity study-A baseline ultrasound image picture produced using sound waves of the brachial artery artery located at the bend of the arm is taken and blood flow measurements are recorded Then a pressure cuff is placed around the upper forearm inflated for 5 minutes to stop blood flow to the forearm and then released Images of the artery and flow measurements are repeated After a 15-minute rest new baseline images are taken and flow measurements obtained A small amount of nitroglycerin is then sprayed under the tongue and after 3 minutes blood flow measurements and brachial artery images are recorded once more
Detailed Description:
Since the publication of the data of the San Antonio Heart Study the link between metabolic and cardiovascular disorders has been increasingly recognized as well as the features these disorders have in common insulin resistance and vascular endothelial dysfunction Therefore we are interested in the mechanisms underlying the impairment of endothelial function in insulin-resistant states In particular we have recently found that insulin stimulates the vascular activity of both ET-1 and NO in the normal human vasculature It is therefore reasonable to speculate that the occurrence of insulin resistance andor endothelial dysfunction may lead to an imbalance in this mechanism with a resulting increased vascular activity of ET-1
A new class of insulin sensitizing agents the thiazolidinediones have been shown to possess in addition to their numerous metabolic roles positive effects on blood pressure and on vascular endothelial function including decreased endothelin-1 production and reduced circulating levels of endothelial surface molecules Based on these data we plan to investigate the hypothesis that thiazolidinediones may improve both insulin resistance and endothelial dysfunction in essential hypertension and hypercholesterolemia We hypothesize that treatment with rosiglitazone improves endothelium-dependent vascular relaxation in both conductance and resistance vessels decreases vascular endothelin-1 activity and reduces plasma levels of leptin and of markers of endothelial activation
A new class of insulin sensitizing agents the thiazolidinediones have been shown to possess in addition to their numerous metabolic roles positive effects on blood pressure and on vascular endothelial function including decreased endothelin-1 production and reduced circulating levels of endothelial surface molecules Based on these data we plan to investigate the hypothesis that thiazolidinediones may improve both insulin resistance and endothelial dysfunction in essential hypertension and hypercholesterolemia We hypothesize that treatment with rosiglitazone improves endothelium-dependent vascular relaxation in both conductance and resistance vessels decreases vascular endothelin-1 activity and reduces plasma levels of leptin and of markers of endothelial activation
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 |
|---|---|---|---|
| 00-H-0175 | None | None | None |