Rosuvastatin in Visceral Adiposity

NCT ID: NCT01068626

Last Updated: 2015-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2008-12-31

Brief 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.

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.

Conditions

Abdominal Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Rosuvastatin

Group Type: ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type: DRUG

10 mg once daily

Placebo for Rosuvastatin

Group Type: PLACEBO_COMPARATOR

Placebo for rosuvastatin

Intervention Type: DRUG

once daily

Interventions

Rosuvastatin

10 mg once daily

Intervention Type: DRUG

Placebo for rosuvastatin

once daily

Intervention Type: DRUG

Other Intervention Names

Crestor®

Eligibility 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sahlgrenska University Hospital

OTHER

Sponsor Role: collaborator

Göteborg University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John-Olov Jansson, Prof

Role: STUDY_CHAIR

Department of Endocrinology, University of Gothenburg

Claes Ohlsson, Professor

Role: STUDY_CHAIR

Department of Clinical Pharmocology, University of Gothenburg

Anna Nilsson, MD, PhD

Role: STUDY_CHAIR

Department of Endocrinology, University of Gothenburg

Kristjan Karason, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Molecular and Clinical Medicine at University of Gothenburg

Locations

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

Gothenburg, , Sweden

Countries

Sweden

Other Identifiers

990312

Identifier Type: -

Identifier Source: org_study_id