PPARgamma Activation by Losartan in Hypertensive Patients: The Importance of Losartan-Metabolites

Hypertension Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00561327
• Other study ID #: P2132V1
• Status: Recruiting
• Phase: N/A
• First received: November 16, 2007
• Last updated: November 16, 2007
• Start date: September 2007

Study information

• Verified date: July 2007
• Source: German Heart Institute
• Contact: Eckart Fleck, Prof
• Phone: +49-30-4593-2400
• Email: fleck[@]dhzb.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine whether losartan metabolites are effective in inducing PPARγ target genes in monocytes in losartan-treated patients.

Description:

The losartan metabolite EXP3179 potently induces the activity of the peroxisome proliferator-activated receptor γ (PPAR-γ) as a partial agonist in vitro. PPAR-γ is a nuclear hormone receptor and functions as a regulator of lipid- and glucose metabolism. PPAR-γ ligands improve insulin sensitivity and glucose tolerance, and reduce cardiovascular morbidity and mortality in diabetic patients.

Angiotensin II receptor 1-blocking and PPAR-γ-activating properties of losartan metabolites in patients would markedly improve the pharmacological profile of losartan by combining anti-hypertensive and highly beneficial metabolic actions. We developed the following hypothesis:

1. Hypertensive patients chronically treated with losartan exhibit sufficient plasma levels of EXP3179 to activate PPARγ.

2. PPARγ target genes are induced in monocytes from losartan-treated patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age: 19-80

• Sex: male or female

• Prior diagnosis of treated hypertension

• Treatment with losartan 100mg/daily during at least the past 2 months (n=20/ case);

• or: no prior angiotensin receptor 1-blocker treatment during the last 2 months (n=10/ control).

Exclusion Criteria:

• Non-steroidal anti-inflammatory drugs (exception: Acetyl salicylic acid) for the past 21 days (due to structural homologies to glitazones, and activating effects on PPAR?)

• Therapy with glitazones for the past 21 days.

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• losartan
Daily treated with losartan 100mg for at least the past 2 months (retrospective, no new drug treatment/ intervention)

Locations

Country	Name	City	State
Germany	German Heart Institute	Berlin

Sponsors (3)

Lead Sponsor	Collaborator
German Heart Institute	Charite University, Berlin, Germany, MSD SHARP and DOHME GMBH Haar Germany

Country where clinical trial is conducted

Germany,