Changes After Angiotensin Converting Enzyme (ACE) Inhibitor Replacement by Angiotensin II Receptor Type I (AT1) Blocker (ADIRAS)
Recruitment status was Recruiting
It is supposed that the significant metabolic effects (improvement of insulin sensitivity) of hypertension therapy with renin-angiotensin system (RAS) blockers in humans are mediated mainly via changes in abdominal adipose tissue. This project is aimed to confirm the hypothesis that increased concentrations of circulatory angiotensin II after angiotensin II receptor type I (AT1) blockade leads, via stimulation of angiotensin II receptor type II (AT2), to activation of adipogenesis and improvement of insulin sensitivity. Therefore, in hypertensive patients, the components of RAS and the parameters of insulin sensitivity on systemic (in plasma) and local (in adipose tissue and in its interstitial fluid) level will be studied. The main aim of the study is to identify the changes occurring in patient before and 6 months after the conversion of therapy from angiotensin converting enzyme (ACE) inhibitors to AT1 receptor blockers. Observed parameters will include gene expression of RAS components, parameters of insulin sensitivity, amount, and cellularity of adipose tissue obtained by biopsy, evaluation of direct production of cytokines and angiotensins into the interstitial fluid of fat tissue obtained by microdialysis and evaluation of the selected parameters in plasma.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Molecular - Genetic Alterations in Adipose Tissue After Change in Therapy From ACE Inhibitors to AT1 Receptor Blockers in Patients With Essential Hypertension|
- Systemic Insulin Sensitivity after Replacement of ACE Inhibitor by AT1 Blocker [ Time Frame: 6 months ] [ Designated as safety issue: No ]Oral glucose tolerance test (OGTT) will be used to determine systemic insulin sensitivity.
- Adipocyte Diameter from Subcutaneous Adipose Tissue after Replacement ACE Inhibitor by AT1 Blocker [ Time Frame: 6 months ] [ Designated as safety issue: No ]The tissue obtai ned by biopsy will be digested by collagenase and the diameter of isolated adipocytes will be evaulated by light microscopy.
|Study Start Date:||October 2008|
|Estimated Study Completion Date:||December 2012|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
|Contact: Stefan Zorad, Dr.||00421 2 54772800 ext email@example.com|
|Contact: Adrian Oksa, MD.||00421 2 59370 ext firstname.lastname@example.org|
|Institute of Experimental Endocrinology, SAS||Recruiting|
|Bratislava, Slovakia, 833 06|
|Contact: Stefan Zorad, Dr. 00421 2 54772800 ext 250 email@example.com|
|Contact: Adela Penesova, MD. 00421 2 54772800 ext 260 firstname.lastname@example.org|
|Principal Investigator: Richard Imrich, MD.|
|Principal Investigator: Katarina Krskova, Dr.|
|Principal Investigator: Miroslav Vlcek, MD.|
|Sub-Investigator: Adrian Oksa, MD.|
|Principal Investigator:||Stefan Zorad, Dr.||Institute of Experimental Endocrinology SAS|