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Rosuvastatin in Visceral Adiposity (RIVIERA)

G

Göteborg University

Status and phase

Completed
Phase 3

Conditions

Abdominal Obesity

Treatments

Drug: Placebo for rosuvastatin
Drug: Rosuvastatin

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 patients

Sex

Male

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

54 participants in 2 patient groups, including a placebo group

Rosuvastatin
Active Comparator group
Treatment:
Drug: Rosuvastatin
Placebo for Rosuvastatin
Placebo Comparator group
Treatment:
Drug: Placebo for rosuvastatin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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