Telmisartan and Losartan in Hypertensive IGT
Primary Purpose
Hypertension, Impaired Glucose Tolerance
Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Telmisartan 80 mg
Losartan 50 mg
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring insulin resistance, beta cell function, endothelial dysfunction
Eligibility Criteria
Inclusion Criteria:
- IGT according the criteria of the WHO
- standardised office blood pressure > 140/90 mmHG or treated hypertension
- 40 - 75 years of age
- signed informed consent
Exclusion Criteria:
- known hypersensitivity towards telmisartan or losartan
- concommitant treatment with ACE-inhibitors
- BMI > 35 kg/m2
- inability to perform self-control of blood pressure
- acute coronary syndrome or cerebrovascular event within the last 3 months
- Revascularisation within the last 3 months
- heart failure > NYHA 2
Sites / Locations
- Medical University of Graz
Outcomes
Primary Outcome Measures
HOMA index
ISI
FMD
Blood pressure surge in the morning
Secondary Outcome Measures
Full Information
NCT ID
NCT00407862
First Posted
December 4, 2006
Last Updated
December 4, 2006
Sponsor
Medical University of Graz
1. Study Identification
Unique Protocol Identification Number
NCT00407862
Brief Title
Telmisartan and Losartan in Hypertensive IGT
Official Title
Telmisartan vs. Losartan in Hypertensive Patients With Impaired Glucose Tolerance: A Comparison of Their Antihypertensive, Metabolic, and Vascular Effects
Study Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of Graz
4. Oversight
5. Study Description
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 PPARγ.
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 and/or 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 PPARγ (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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Impaired Glucose Tolerance
Keywords
insulin resistance, beta cell function, endothelial dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
24 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Telmisartan 80 mg
Intervention Type
Drug
Intervention Name(s)
Losartan 50 mg
Primary Outcome Measure Information:
Title
HOMA index
Title
ISI
Title
FMD
Title
Blood pressure surge in the morning
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
IGT according the criteria of the WHO
standardised office blood pressure > 140/90 mmHG or treated hypertension
40 - 75 years of age
signed informed consent
Exclusion Criteria:
known hypersensitivity towards telmisartan or losartan
concommitant treatment with ACE-inhibitors
BMI > 35 kg/m2
inability to perform self-control of blood pressure
acute coronary syndrome or cerebrovascular event within the last 3 months
Revascularisation within the last 3 months
heart failure > NYHA 2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas C. Wascher, MD
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
12. IPD Sharing Statement
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Telmisartan and Losartan in Hypertensive IGT
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