Rosuvastatin in Visceral Adiposity

Göteborg University54 enrolled

Overview

The purpose of this study is to investigate whether 6 months treatment with the cholesterol-lowering drug rosuvastatin may reduce visceral fat tissue in obese middle aged men.

The accumulation of intra-abdominal fat has been suggested to be of primary importance in the development of the metabolic syndrome and associated metabolic disturbances and it has been hypothesized that a selective reduction of visceral fat tissue would improve the symptoms of the metabolic syndrome. Treatment with statins decrease levels of LDL-cholesterol and reduce coronary artery disease (CAD) events. Although it is widely accepted that the majority of benefit obtained with statins is a direct result of their lipid-lowering properties, they also demonstrate additional cholesterol-independent or pleiotropic effects. The results of experimental studies have now shown that statins decrease fat mass in the visceral region in an animal model. In the present study, we will investigate whether statins can decrease visceral obesity in humans.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Abdominal Obesity

Interventions

RosuvastatinDRUG

10 mg once daily

Placebo for rosuvastatinDRUG

once daily

Eligibility

Sex: MALEMin age: 40 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male patients between 40 and 65 years of age. * Abdominal obesity * Dyslipidemia * Written informed consent. Exclusion Criteria: * Uncontrolled hypertension * Diabetes mellitus * Severe liver disease * Severely reduced renal function * Uncontrolled endocrine disorders * History of or ongoing malignant disease * Patients with known myopathic disease * Recent alcohol or drug abuse * Weight loss or weight gain during the three months prior to screening. * Ongoing treatment with statins * Ongoing treatment with calcineurin-inhibitors * Ongoing treatment with anti-inflammatory drugs * Received an investigational drug within 30 days prior to screening. * Strong clinical indication for statin treatment * In the Principal Investigator's opinion, the patient has other clinically significant cardiac, oncologic, neurologic or psychiatric disease that could be adversely affected by Study participation. * For any reason the patient is considered by the Principal Investigator to be an unsuitable candidate to participate in the Study.

Locations (1)

Department of Molecular and Clinical Medicine, Sahlgrenska Academy at University of Gothernburg

Gothenburg, Sweden

Outcomes

Primary Outcomes

Change in Visceral Adipose Tissue Area Measured by Computed Tomography.

Time frame: 6 months

Secondary Outcomes

Change in Subcutaneous Adipose Tissue Area

Time frame: 6 months

Change in the Ratio Between Intra-abdominal and Subcutaneous Tissue Area Measured by CT.

Time frame: 6 months

Change in Hepatic Fat Infiltration Measured by CT.

Time frame: 6 months

Change in Body Weight

Time frame: 6 months

Change in LDL

Time frame: 6 months

Data from ClinicalTrials.gov

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