Rosuvastatin in Visceral Adiposity (RIVIERA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01068626
Recruitment Status : Completed
First Posted : February 15, 2010
Results First Posted : March 2, 2011
Last Update Posted : August 24, 2015
Sahlgrenska University Hospital, Sweden
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Abdominal Obesity Drug: Rosuvastatin Drug: Placebo for rosuvastatin Phase 3

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  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : May 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Rosuvastatin Drug: Rosuvastatin
10 mg once daily
Other Name: Crestor®
Placebo Comparator: Placebo for Rosuvastatin Drug: Placebo for rosuvastatin
once daily

Primary Outcome Measures :
  1. Change in Visceral Adipose Tissue Area Measured by Computed Tomography. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change in Subcutaneous Adipose Tissue Area [ Time Frame: 6 months ]
  2. Change in the Ratio Between Intra-abdominal and Subcutaneous Tissue Area Measured by CT. [ Time Frame: 6 months ]
  3. Change in Hepatic Fat Infiltration Measured by CT. [ Time Frame: 6 months ]
  4. Change in Body Weight [ Time Frame: 6 months ]
  5. Change in LDL [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01068626

Department of Molecular and Clinical Medicine, Sahlgrenska Academy at University of Gothernburg
Gothenburg, Sweden, 413 45
Sponsors and Collaborators
Göteborg University
Sahlgrenska University Hospital, Sweden
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

Responsible Party: Göteborg University Identifier: NCT01068626     History of Changes
Other Study ID Numbers: 990312
First Posted: February 15, 2010    Key Record Dates
Results First Posted: March 2, 2011
Last Update Posted: August 24, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Obesity, Abdominal
Nutrition Disorders
Body Weight
Signs and Symptoms
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors