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| Name | Class |
|---|---|
| Sahlgrenska University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin | Active Comparator |
| |
| Placebo for Rosuvastatin | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | 10 mg once daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visceral Adipose Tissue Area Measured by Computed Tomography. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Subcutaneous Adipose Tissue Area | 6 months | |
| Change in the Ratio Between Intra-abdominal and Subcutaneous Tissue Area Measured by CT. | 6 months | |
| Change in Hepatic Fat Infiltration Measured by CT. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John-Olov Jansson, Prof | Department of Endocrinology, University of Gothenburg | Study Chair |
| Claes Ohlsson, Professor | Department of Clinical Pharmocology, University of Gothenburg | Study Chair |
| Anna Nilsson, MD, PhD | Department of Endocrinology, University of Gothenburg | Study Chair |
| Kristjan Karason, MD, PhD | Department of Molecular and Clinical Medicine at University of Gothenburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Molecular and Clinical Medicine, Sahlgrenska Academy at University of Gothernburg | Gothenburg | 413 45 | Sweden |
Among patients that were screened 19 patients did not fulfill inclusion criteria or displayed exclusion criteria and did not enter the study.
From May 2006 to July 2007 a total of 78 subjects were screened at the Sahlgrenska Hospital. Among these, 59 fulfilled all inclusion and no exclusion criteria and were randomized to treatment. During follow-up 5 patients (7 %) withdrew from the study, resulting in 54 patients who completed the study, comprising 27 patients in each study group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rosuvastatin | |
| FG001 | Placebo for Rosuvastatin |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rosuvastatin | |
| BG001 | Placebo for Rosuvastatin | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Visceral Adipose Tissue Area Measured by Computed Tomography. | Per protocol | Posted | Mean | Standard Deviation | cm2 | 6 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rosuvastatin |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristjan Karason | University of Gothenburg | +46 31 342 7554 | kristjan.karason@gu.se |
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| ID | Term |
|---|---|
| D056128 | Obesity, Abdominal |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Placebo for rosuvastatin | Drug | once daily |
|
| 6 months |
| Change in Body Weight | 6 months |
| Change in LDL | 6 months |
Total of all reporting groups
| participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex/Gender, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | m |
|
| Hypertension | Number | participants |
|
| Current smoker | Number | participants |
|
| Visceral adipose tissue area | Visceral adipose tissue area measured with CT at the level of the fourth lumbar vertebrae. | Mean | Standard Deviation | cm2 |
|
| Subcutaneous adipose tissue area | Subcutaneous adipose tissue area measured with CT at the level of the fourth lumbar vertebrae. | Mean | Standard Deviation | cm2 |
|
| Visceral/subcutaneous adipose tissue area ratio | Mean | Standard Deviation | ratio |
|
| Liver density | Liver density measured by computed tomography | Mean | Standard Deviation | Hounsfield units |
|
| LDL cholesterol | Mean | Standard Deviation | mmol/L |
|
| Fasting glucose | Mean | Standard Deviation | mmol/L |
|
| Fasting insulin | Mean | Standard Deviation | IU |
|
|
| Secondary | Change in Subcutaneous Adipose Tissue Area | Posted | Mean | Standard Deviation | cm2 | 6 months |
|
|
|
| Secondary | Change in the Ratio Between Intra-abdominal and Subcutaneous Tissue Area Measured by CT. | Posted | Mean | Standard Deviation | ratio | 6 months |
|
|
|
| Secondary | Change in Hepatic Fat Infiltration Measured by CT. | Posted | Mean | Standard Deviation | Hounsfield units | 6 months |
|
|
|
| Secondary | Change in Body Weight | Posted | Mean | Standard Deviation | kg | 6 months |
|
|
|
| Secondary | Change in LDL | Posted | Mean | Standard Deviation | mmol/L | 6 months |
|
|
|
| 3 |
| 30 |
| 3 |
| 30 |
| EG001 | Placebo for Rosuvastatin | 1 | 29 | 5 | 29 |
| Depression | Psychiatric disorders | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review results communications during 3 months prior to public release and can embargo communications regarding trial results for an additional period of 3 months from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |