Losartan and Simvastatin in Hypertensive Obeses With Liver Steatosis

April 28, 2008 updated by: University of Pavia

Ultrasonographic Modification of Liver Steatosis and Visceral Fat Induced by Treatment With Losartan and Simvastatin in Hypertensive Normocholesterolemic Obese Patients

Angiotensin II has been proposed as a lipid metabolism regulator. It is known that adipocytes secrete a variety of protein, such as TNFα, plasminogen activator inhibitor (PAI)-1, leptin, resistin and adiponectin; these proteins have a wide range of biological effects and are associated with insulin resistance. Adipocytes also produce angiotensinogen and angiotensin II and a local renin-angiotensin system (RAS) is present in adipose tissue. In overweight or obese hypertensive normocholesterolemic patients the treatment with AT1-receptor blocker (Losartan) may have a better effect on hepatic steatosis and visceral fat deposition than the antihypertensive treatment with calcium channel blocker (amlodipine). Simvastatin will be added to both groups. The aim of this study is to evaluate the effect of losartan and simvastatin on ultrasonographic qualitative and quantitative parameters in overweight or obese hypertensive normocholesterolemic patients with hepatic steatosis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Giuseppe Derosa
  • Phone Number: 39-038-250-2614

Study Locations

  • Italy
      • Pavia, Italy
        • Recruiting
        • University of Pavia
        • Contact:
          • Giuseppe Derosa, MD
          • Phone Number: 39-038-250-2614

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Gender: 50% Male and 50% female
  • Age: 40-80 years
  • Race: Caucasian
  • Overweight or obese: respectively BMI25-30 kg/m2 or BMI > 30 kg m2
  • Hypertensive: PA > 140/90 mmHg
  • Normocholesterolemic (LDL< 160 mg/dl HDL > 35 mg/dl)
  • Liver steatosis

Exclusion Criteria:

  • other antihypertensive treatment after wash out period of 2 weeks
  • abnormal heart rest function (EF < 55%).
  • valvular heart disease
  • congenital heart disease
  • heart failure or prior myocardial infarction
  • diabetes
  • renal disease
  • liver disease
  • connective tissue disease
  • pregnancy or lactation
  • serious adverse experience
  • sensitivity to the study drugs or its components
  • contraindication from an approved label

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Amlodipine and Simvastatin
Drug: Amlodipine + Simvastatin

tablets; 5, 10 mg; od; 12 months

tablets; 20 mg; od; 6 months
EXPERIMENTAL: 2
Losartan and Simvastatin
Drug: Losartan + Simvastatin

tablets; 50, 100 mg; od; 12 months

tablets; 20 mg; od; 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All patients will undergo anthropometric evaluation and abdominal ultrasonography (performed by the same examiner); will be taken routine liver US and US measurement of visceral and subcutaneous fat.
Time Frame: Between 08.00 and 10.00 at baseline, and after 1, 6, and 12 months
Between 08.00 and 10.00 at baseline, and after 1, 6, and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Determination of insulin sensitivity, leptin, adiponectin, TNFα, IL6, hsPCR
Time Frame: Between 08.00 and 10.00 at baseline, and after 1, 6, and 12 months
Between 08.00 and 10.00 at baseline, and after 1, 6, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

April 1, 2008

Study Completion (ANTICIPATED)

April 1, 2009

Study Registration Dates

First Submitted

April 25, 2008

First Submitted That Met QC Criteria

April 28, 2008

First Posted (ESTIMATE)

April 30, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 30, 2008

Last Update Submitted That Met QC Criteria

April 28, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNIPV003DIM2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on Amlodipine + Simvastatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe