Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00407862
Status:
COMPLETED
Last Update Posted:
2006-12-05
First Post:
2006-12-04
Brief Title:
Telmisartan and Losartan in Hypertensive IGT
Sponsor:
Medical University of Graz
Organization:
Medical University of Graz
Study Overview
Official Title:
Telmisartan vs Losartan in Hypertensive Patients With Impaired Glucose Tolerance A Comparison of Their Antihypertensive Metabolic and Vascular Effects
Status:
COMPLETED
Status Verified Date:
2006-12
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:
Inhibition of RAS delays onset of diabetes in clinical studies Preliminary evidence suggests that telmisartan may have unique metabolic properties compared to other ARB due to activation of PPARĪ³
This should be tested in comparison with an ARB that is metabolically neutral in already published studies
H0 Telmisartan is not different from Losartan with respect to metabolic and vascular effects
H1 Telmisartan is different from Losartan with respect to metabolic and vascular effects
This should be tested in comparison with an ARB that is metabolically neutral in already published studies
H0 Telmisartan is not different from Losartan with respect to metabolic and vascular effects
H1 Telmisartan is different from Losartan with respect to metabolic and vascular effects
Detailed Description:
Background Both ACE-inhibitors as well as angiotensin-II-type-1 AT1 receptor antagonists seem to reduce the development of type-II diabetes in patients with hypertension andor high vascular risk 1-3 The major drawback of that evidence is that it derives from post-hoc analyses in studies with rather poor metabolic phenotypisation of the populations included Additionally all that evidence is based on measurements of fasting plasma glucose
In subjects with impaired glucose tolerance IGT insulin resistance and dysfunction of pancreatic beta-cells in variable contribution have already established increased postprandial hyperglycemia with a consecutively increased cardiovascular risk 4 5 In addition they have a considerable risk for future development of manifest type-II diabetes in the range of 3-6 within a year 6 7 In such patients prevention of diabetes may also result in cardiovascular prevention As subjects with IGT often exhibit a more or less pronounced metabolic syndrome hypertension is a frequently found comorbidity and vice versa IGT is frequent in hypertensive patients suggesting a possible common soil of the two diseases 8
Given these evidences hypertensive subjects with IGT are a very suitable target population to study metabolic and vascular effects of an angiotensin-II-type-1-receptor antagonist
Finally it has to be acknowledged that insulin resistance needs to be seen in the context of the proinflammatory changes of the metabolic syndrome the endothelial dysfunction associated and the possibly central role of the adipocyte Fig 1 Within that context the hypothesis was put forward that blockade of the angiotensin system might prevent type-II diabetes via effects on fat cells 9
Rationale The effects of different angiotensin-II-type-1-receptor antagonists on insulin sensitivity have been investigated in various studies with different either positive 10 or negative 11 12 results but no in-depht investigations into detailed metabolic and vascular effects have been performed
Telmisartan is an angiotensin-II-type-1-receptor antagonist that very recently has been described to possess the specific properties of a partial activator of PPARĪ³ 13 This effect is not found for other comparable compunds such as losartan Genes of whom the expression is under control of that receptor are centrally involved into the pathology of the metabolic syndrome as outlined above and activation of that receptor results in improved insulin sensitivity ameliorated endothelial dysfunction reduced inflammation and potentially preserved beta-cell function for review see 14 Therefore telmisartan is a candidate that might possess very specific beneficial properties in addition to its antihypertensive effects
Objective To compare the metabolic and vascular effects of telmisartan and metoprolol in hypertensive patients with IGT
In subjects with impaired glucose tolerance IGT insulin resistance and dysfunction of pancreatic beta-cells in variable contribution have already established increased postprandial hyperglycemia with a consecutively increased cardiovascular risk 4 5 In addition they have a considerable risk for future development of manifest type-II diabetes in the range of 3-6 within a year 6 7 In such patients prevention of diabetes may also result in cardiovascular prevention As subjects with IGT often exhibit a more or less pronounced metabolic syndrome hypertension is a frequently found comorbidity and vice versa IGT is frequent in hypertensive patients suggesting a possible common soil of the two diseases 8
Given these evidences hypertensive subjects with IGT are a very suitable target population to study metabolic and vascular effects of an angiotensin-II-type-1-receptor antagonist
Finally it has to be acknowledged that insulin resistance needs to be seen in the context of the proinflammatory changes of the metabolic syndrome the endothelial dysfunction associated and the possibly central role of the adipocyte Fig 1 Within that context the hypothesis was put forward that blockade of the angiotensin system might prevent type-II diabetes via effects on fat cells 9
Rationale The effects of different angiotensin-II-type-1-receptor antagonists on insulin sensitivity have been investigated in various studies with different either positive 10 or negative 11 12 results but no in-depht investigations into detailed metabolic and vascular effects have been performed
Telmisartan is an angiotensin-II-type-1-receptor antagonist that very recently has been described to possess the specific properties of a partial activator of PPARĪ³ 13 This effect is not found for other comparable compunds such as losartan Genes of whom the expression is under control of that receptor are centrally involved into the pathology of the metabolic syndrome as outlined above and activation of that receptor results in improved insulin sensitivity ameliorated endothelial dysfunction reduced inflammation and potentially preserved beta-cell function for review see 14 Therefore telmisartan is a candidate that might possess very specific beneficial properties in addition to its antihypertensive effects
Objective To compare the metabolic and vascular effects of telmisartan and metoprolol in hypertensive patients with IGT
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