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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01068626
Other study ID # 990312
Secondary ID
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


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
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