Rosuvastatin in Visceral Adiposity (RIVIERA)

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

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Obesity
• Intervention / Treatment: Drug: Rosuvastatin; Drug: Placebo for rosuvastatin

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 3

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 413 45
    • Department of Molecular and Clinical Medicine, Sahlgrenska Academy at University of Gothernburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rosuvastatin	Drug: Rosuvastatin; 10 mg once daily; Other Names: Crestor®
Placebo Comparator: Placebo for Rosuvastatin	Drug: Placebo for rosuvastatin; once daily

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Göteborg University
• Collaborators: Sahlgrenska University Hospital, Sweden
• Investigators: Study Chair: John-Olov Jansson, Prof, Department of Endocrinology, University of Gothenburg; Study Chair: Claes Ohlsson, Professor, Department of Clinical Pharmocology, University of Gothenburg; Study Chair: Anna Nilsson, MD, PhD, Department of Endocrinology, University of Gothenburg; Principal Investigator: Kristjan Karason, MD, PhD, Department of Molecular and Clinical Medicine at University of Gothenburg

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: February 12, 2010
• First Submitted That Met QC Criteria: February 12, 2010
• First Posted (Estimate): February 15, 2010

Study Record Updates

• Last Update Posted (Estimate): August 24, 2015
• Last Update Submitted That Met QC Criteria: August 6, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Abdominal; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: 990312