Clinical trial NCT01068626: Rosuvastatin in Visceral Adiposity
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Abdominal Obesity
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
First posted: 2010-02-15
Enrollment: 54
Sex: MALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Visceral Adipose Tissue Area Measured by Computed Tomography.
timeFrame: 6 months
Secondary outcomes:
measure: Change in Subcutaneous Adipose Tissue Area
timeFrame: 6 months
measure: Change in the Ratio Between Intra-abdominal and Subcutaneous Tissue Area Measured by CT.
timeFrame: 6 months
measure: Change in Hepatic Fat Infiltration Measured by CT.
timeFrame: 6 months
measure: Change in Body Weight
timeFrame: 6 months
measure: Change in LDL
timeFrame: 6 months
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Department of Molecular and Clinical Medicine, Sahlgrenska Academy at University of Gothernburg
Study officials:
affiliation: Department of Endocrinology, University of Gothenburg
name: John-Olov Jansson, Prof
role: STUDY_CHAIR
affiliation: Department of Clinical Pharmocology, University of Gothenburg
name: Claes Ohlsson, Professor
role: STUDY_CHAIR
affiliation: Department of Endocrinology, University of Gothenburg
name: Anna Nilsson, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Molecular and Clinical Medicine at University of Gothenburg
name: Kristjan Karason, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: