Rosuvastatin in Visceral Adiposity

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

Official Title
-----------------
A 26-week, Single Center, Randomized, Placebo-controlled, Double-blind, Parallel-group Study to Evaluate the Effect of Rosuvastatin on Visceral Adipose Tissue in Male Patients With Abdominal Obesity

Conditions
-----------------
Abdominal Obesity

Intervention / Treatment
-----------------
* Drug: Rosuvastatin
* Drug: Placebo for rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rosuvastatin<br> | Drug: Rosuvastatin<br>* 10 mg once daily<br>* Other names: Crestor®;|
| Placebo Comparator: Placebo for Rosuvastatin<br> | Drug: Placebo for rosuvastatin<br>* once daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visceral Adipose Tissue Area Measured by Computed Tomography. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Subcutaneous Adipose Tissue Area |  | 6 months | 
| Change in the Ratio Between Intra-abdominal and Subcutaneous Tissue Area Measured by CT. |  | 6 months | 
| Change in Hepatic Fat Infiltration Measured by CT. |  | 6 months | 
| Change in Body Weight |  | 6 months | 
| Change in LDL |  | 6 months |