Changes After Angiotensin Converting Enzyme (ACE) Inhibitor Replacement by Angiotensin II Receptor Type I (AT1) Blocker

NCT01444833 | Unknown

• 2 other identifiers: MinHealth2007/27-SAV-02
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Keywords

hypertension; obesity; metabolism; angiotensin

Outcome Measures

Primary Outcomes (1)

• Systemic Insulin Sensitivity after Replacement of ACE Inhibitor by AT1 Blocker

  Oral glucose tolerance test (OGTT) will be used to determine systemic insulin sensitivity.

  6 months

Secondary Outcomes (1)

• Adipocyte Diameter from Subcutaneous Adipose Tissue after Replacement ACE Inhibitor by AT1 Blocker

  6 months

Interventions

Candesartan DRUG

32 mg per day duration 6 months

Also known as: Atacand

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• essential hypertension
• ACE inhibitors

You may not qualify if:

• diabetes mellitus
• endocrinopathies
• no smokers

Sponsors & Collaborators

• Slovak Academy of Sciences: lead

Study Sites (1)

Institute of Experimental Endocrinology, SAS

Bratislava, 833 06, Slovakia

RECRUITING

Related Publications (41)

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MeSH Terms

Conditions

Hypertension; Obesity

Interventions

candesartan; candesartan cilexetil

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefan Zorad, Dr.

  Institute of Experimental Endocrinology SAS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Zorad, Dr.

CONTACT

00421 2 54772800; stefan.zorad@savba.sk

Adrian Oksa, MD.

CONTACT

00421 2 59370; adrian.oksa@szu.sk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Laboratory

Study Record Dates

• First Submitted: September 19, 2011
• First Posted: October 3, 2011
• Study Start: October 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: December 1, 2012
• Last Updated: October 3, 2011

Record last verified: 2011-09

Locations

SL (1)