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CompletedNCT00407862Updated Dec 5, 2006

Telmisartan and Losartan in Hypertensive IGT

A Phase 4 interventional study of Telmisartan 80 mg and Losartan 50 mg in Hypertension and Impaired Glucose Tolerance, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2006-12-05.

Sponsored by Medical University of Graz · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypertension
  • Impaired Glucose Tolerance

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Keywords

  • insulin resistance
  • beta cell function
  • endothelial dysfunction
03

In context

Glucose Intolerance

778 studies on the registry are indexed under Glucose Intolerance; 129 are open to participants now.

This study's enrollment of 24 is below the median of 60 across 645 interventional studies indexed under Glucose Intolerance.

Browse Glucose Intolerance studies →

Lead sponsor

Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
24 participants

Interventions

  • DrugTelmisartan 80 mg
  • DrugLosartan 50 mg
06

What researchers measure

Primary outcomes

  1. HOMA index

  2. ISI

  3. FMD

  4. Blood pressure surge in the morning

07

Study locations

1 site
  • Medical University of Graz
    Graz, 8036, Austria
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00407862
Lead sponsor
Medical University of Graz
First posted
Dec 5, 2006
Start date
Jan 2005
Completion
Jun 2006
Last update
Dec 5, 2006

Study contacts

Thomas C. Wascher, MD
principal investigator · Medical University of Graz
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2006. You cannot join it, but the record below documents what was studied.

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