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Rosuvastatin in Visceral Adiposity. A 26-week, single center, randomised, placebo-controlled, double-blind, parallel-group study to evaluate the effect of rosuvastatin on visceral adipose tissue in male subjects with abdominal obesity - RIVIERA

Rosuvastatin in Visceral Adiposity. A 26-week, single center, randomised, placebo-controlled, double-blind, parallel-group study to evaluate the effect of rosuvastatin on visceral adipose tissue in male subjects with abdominal obesity - RIVIERA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-001048-22-SE
Enrollment
Unknown
Registered
2005-08-24
Start date
2005-12-29
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visceral adiposity

Interventions

Trade Name: Crestor® Product Name: Rosuvastatincaclium Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Sponsors

Göteborg University, Institute for Internal Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Male patients between 40 and 65 years of age with abdominal obesity defined by a waist circumference greater than or equal to 102 cm and dyslipidemia (LDL-cholesterol = 3.0 mmol/l or HDL-cholesterol = 1.0 mmol/l or Triglycerids = 1.7 mmol/l). Informed concent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Uncontrolled hypertension, diabetes mellitus, severe liver disease, severely reduced renal function, endocrine disorders, malignant disease, myopathic disease, alcohol or drug abuse, ongoing treatment with statins, anti-obesity drugs, anti-inflammatory drugs or immunosuppressive drugs.

Design outcomes

Primary

MeasureTime frame
Main Objective: To investigate the effect of a 26-week rosuvastatin-treatment compared with placebo on visceral adipose tissue area in male subjects with abdominal adiposity (CT).;Secondary Objective: To determine the effect of statin-treatment on fatty infiltration in the liver (CT), muscle attenuation values (CT), glycemia, lipid levels and gene expression in subcutaneous adipose tissue.;Primary end point(s): Change from baseline in the intra-abdominal adipose tissue area measured by computed tomography.—

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026