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Completed

NCT Number: NCT01068626

Rosuvastatin in Visceral Adiposity

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.

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Key information

Age range

40 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Department of Molecular and Clinical Medicine, Sahlgrenska Academy at University of Gothernburg

Gothenburg, 413 45, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rosuvastatin

Drug

10 mg once daily

Other names: Crestor®

Placebo for Rosuvastatin

Drug

once daily

Primary outcomes

  1. Change in Visceral Adipose Tissue Area Measured by Computed Tomography.

    Time frame: 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Sahlgrenska University Hospital

Registry information

Official study 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

Acronym: RIVIERA

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Feb 15, 2010
Registry last updated
Aug 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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