Rosuvastatin in Visceral Adiposity (RIVIERA)

This study has been completed.
Sponsor:
Collaborator:
Sahlgrenska University Hospital, Sweden
Information provided by:
Göteborg University
ClinicalTrials.gov Identifier:
NCT01068626
First received: February 12, 2010
Last updated: February 7, 2011
Last verified: December 2005
  Purpose

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 Intervention Phase
Abdominal Obesity
Drug: Rosuvastatin
Drug: Placebo for rosuvastatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • Change in Visceral Adipose Tissue Area Measured by Computed Tomography. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Subcutaneous Adipose Tissue Area [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in the Ratio Between Intra-abdominal and Subcutaneous Tissue Area Measured by CT. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in Hepatic Fat Infiltration Measured by CT. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in Body Weight [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in LDL [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: May 2006
Study Completion Date: December 2008
Arms Assigned Interventions
Active Comparator: Rosuvastatin Drug: Rosuvastatin
10 mg once daily
Other Name: Crestor®
Placebo Comparator: Placebo for Rosuvastatin Drug: Placebo for rosuvastatin
once daily

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.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01068626

Locations
Sweden
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
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
  More Information

No publications provided

Responsible Party: Kristjan Karason, Department of Molecular and Clinical Medicine, Sahlgrenska Academy at the University of Gothenburg
ClinicalTrials.gov Identifier: NCT01068626     History of Changes
Other Study ID Numbers: 990312
Study First Received: February 12, 2010
Results First Received: February 7, 2011
Last Updated: February 7, 2011
Health Authority: Sweden: Medical Products Agency

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

ClinicalTrials.gov processed this record on July 23, 2014