Rosuvastatin in Visceral Adiposity (RIVIERA)

Göteborg University

Status and phase

Completed

Phase 3

Conditions

Abdominal Obesity

Treatments

Drug: Placebo for rosuvastatin

Drug: Rosuvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT01068626

990312

Details and patient eligibility

About

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.

Full description

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.

Enrollment

54 patients

Sex

Male

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

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.