Rosuvastatin in Visceral Adiposity

Abdominal Obesity Clinical Trial

— RIVIERA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01068626
• Other study ID #: 990312
• Status: Completed
• Phase: Phase 3
• First received: February 12, 2010
• Last updated: August 6, 2015
• Start date: May 2006
• Est. completion date: December 2008

Study information

• Verified date: August 2015
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Obesity
• Obesity, Abdominal

Intervention

Drug:
• Rosuvastatin
10 mg once daily
• Placebo for rosuvastatin
once daily

Locations

Country	Name	City	State
Sweden	Department of Molecular and Clinical Medicine, Sahlgrenska Academy at University of Gothernburg	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Visceral Adipose Tissue Area Measured by Computed Tomography.		6 months	No
Secondary	Change in Subcutaneous Adipose Tissue Area		6 months	No
Secondary	Change in the Ratio Between Intra-abdominal and Subcutaneous Tissue Area Measured by CT.		6 months	No
Secondary	Change in Hepatic Fat Infiltration Measured by CT.		6 months	No
Secondary	Change in Body Weight		6 months	No
Secondary	Change in LDL		6 months	No