Rosuvastatin in Visceral Adiposity

Phase 3

Completed

• Conditions: Abdominal Obesity
• Interventions: Drug: Placebo for rosuvastatin; Drug: Rosuvastatin

• Registration Number: NCT01068626
• Lead Sponsor: Göteborg University

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.

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2008-10
• Study Completion: 2008-12
• Study First Submitted: 2010-02-12
• Study First Submitted QC: 2010-02-12
• Study First Posted: 2010-02-15
• Results First Submitted: 2011-02-07
• Results First Submitted QC: 2011-02-07
• Results First Posted: 2011-03-02
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-06
• Last Update Posted: 2015-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo for Rosuvastatin	Placebo for rosuvastatin	-
Rosuvastatin	Rosuvastatin	-

Primary Outcome Measures

Name	Time	Method
Change in Visceral Adipose Tissue Area Measured by Computed Tomography.	6 months

Secondary Outcome Measures

Name	Time	Method
Change in Subcutaneous Adipose Tissue Area	6 months
Change in LDL	6 months
Change in Hepatic Fat Infiltration Measured by CT.	6 months
Change in the Ratio Between Intra-abdominal and Subcutaneous Tissue Area Measured by CT.	6 months
Change in Body Weight	6 months

Trial Locations

Locations (1)

Department of Molecular and Clinical Medicine, Sahlgrenska Academy at University of Gothernburg; 🇸🇪 Gothenburg, Sweden