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CompletedNCT01068626RIVIERAUpdated Aug 24, 2015Results posted

Rosuvastatin in Visceral Adiposity

A Phase 3 interventional study of Rosuvastatin and Placebo for rosuvastatin in Abdominal Obesity, sponsored by Göteborg University. Completed at 1 site in Sweden. Open to male participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-08-24.

Sponsored by Göteborg University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Abdominal Obesity
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.

This study's enrollment of 54 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Göteborg University is the lead sponsor of 265 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Male patients between 40 and 65 years of age.
  • Abdominal obesity
  • Dyslipidemia
  • Written informed consent.

Exclusion criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • Active comparator
    Rosuvastatin

    Drug: Rosuvastatin

  • Placebo comparator
    Placebo for Rosuvastatin

    Drug: Placebo for rosuvastatin

Interventions

  • DrugRosuvastatin

    10 mg once daily

    Also known as: Crestor®

  • DrugPlacebo for rosuvastatin

    once daily

06

What researchers measure

Primary outcomes

  1. Change in Visceral Adipose Tissue Area Measured by Computed Tomography.

    Time frame: 6 months

Secondary outcomes

  1. Change in Subcutaneous Adipose Tissue Area

    Time frame: 6 months

  2. Change in the Ratio Between Intra-abdominal and Subcutaneous Tissue Area Measured by CT.

    Time frame: 6 months

  3. Change in Hepatic Fat Infiltration Measured by CT.

    Time frame: 6 months

  4. Change in Body Weight

    Time frame: 6 months

  5. Change in LDL

    Time frame: 6 months

07

Results

Posted Mar 2, 2011

Participant flow

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.

Participant flow — Overall Study
MilestoneRosuvastatinPlacebo for Rosuvastatin
Started3029
Completed2727
Not completed32
Withdrew: Adverse event30
Withdrew: Withdrawal by subject02

Outcome measures

PrimaryChange in Visceral Adipose Tissue Area Measured by Computed Tomography.
Time frame:
6 months
Reported as:
Mean · cm2
Change in Visceral Adipose Tissue Area Measured by Computed Tomography.
cm2RosuvastatinPlacebo for Rosuvastatin
Change in Visceral Adipose Tissue Area Measured by Computed Tomography.-1.5 ± 272.8 ± 26
SecondaryChange in Subcutaneous Adipose Tissue Area
Time frame:
6 months
Reported as:
Mean · cm2
Change in Subcutaneous Adipose Tissue Area
cm2RosuvastatinPlacebo for Rosuvastatin
Change in Subcutaneous Adipose Tissue Area10 ± 341 ± 15
SecondaryChange in the Ratio Between Intra-abdominal and Subcutaneous Tissue Area Measured by CT.
Time frame:
6 months
Reported as:
Mean · ratio
Change in the Ratio Between Intra-abdominal and Subcutaneous Tissue Area Measured by CT.
ratioRosuvastatinPlacebo for Rosuvastatin
Change in the Ratio Between Intra-abdominal and Subcutaneous Tissue Area Measured by CT.-0.02 ± 0.110.01 ± 0.08
SecondaryChange in Hepatic Fat Infiltration Measured by CT.
Time frame:
6 months
Reported as:
Mean · Hounsfield units
Change in Hepatic Fat Infiltration Measured by CT.
Hounsfield unitsRosuvastatinPlacebo for Rosuvastatin
Change in Hepatic Fat Infiltration Measured by CT.0 ± 5.2-2 ± 5.0
SecondaryChange in Body Weight
Time frame:
6 months
Reported as:
Mean · kg
Change in Body Weight
kgRosuvastatinPlacebo for Rosuvastatin
Change in Body Weight0.2 ± 2.60.5 ± 1.5
SecondaryChange in LDL
Time frame:
6 months
Reported as:
Mean · mmol/L
Change in LDL
mmol/LRosuvastatinPlacebo for Rosuvastatin
Change in LDL-1.4 ± 0.9-0.1 ± 0.9

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Rosuvastatin—3/30 (10%)3/30 (10%)
Placebo for Rosuvastatin—1/29 (3.4%)5/29 (17.2%)
Most frequent serious events
Most frequent serious events
EventRosuvastatinPlacebo for Rosuvastatin
Low back painMusculoskeletal and connective tissue disorders2/300/29
Rib fractureInjury, poisoning and procedural complications0/301/29
DepressionPsychiatric disorders1/300/29
Most frequent other events
Most frequent other events
EventRosuvastatinPlacebo for Rosuvastatin
DyspepsiaGastrointestinal disorders3/305/29

Baseline characteristics

Age, Customized
Age, Customized(participants)RosuvastatinPlacebo for RosuvastatinTotal
Between 18 and 65 years302959
Age, Continuous
Age, Continuous(years)RosuvastatinPlacebo for RosuvastatinTotal
Mean54 ± 5.255 ± 4.154 ± 4.7
Sex/Gender, Customized
Sex/Gender, Customized(participants)RosuvastatinPlacebo for RosuvastatinTotal
Male302959
Region of Enrollment
Region of Enrollment(participants)RosuvastatinPlacebo for RosuvastatinTotal
Sweden302959
Weight
Weight(kg)RosuvastatinPlacebo for RosuvastatinTotal
Mean100 ± 12100 ± 13100 ± 13
Height
Height(m)RosuvastatinPlacebo for RosuvastatinTotal
Mean1.82 ± 0.061.80 ± 0.071.81 ± 0.07
Hypertension
Hypertension(participants)RosuvastatinPlacebo for RosuvastatinTotal
YES8715
NO222244
Current smoker
Current smoker(participants)RosuvastatinPlacebo for RosuvastatinTotal
YES369
NO272350

7 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Department of Molecular and Clinical Medicine, Sahlgrenska Academy at University of Gothernburg
    Gothenburg, 413 45, Sweden
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01068626
Lead sponsor
Göteborg University
Collaborators
Sahlgrenska University Hospital
Responsible party
Sponsor
First posted
Feb 15, 2010
Start date
May 2006
Primary completion
Oct 2008
Completion
Dec 2008
Results posted
Mar 2, 2011
Last update
Aug 24, 2015

Study contacts

John-Olov Jansson, Prof
study chair · Department of Endocrinology, University of Gothenburg
Claes Ohlsson, Professor
study chair · Department of Clinical Pharmocology, University of Gothenburg
Anna Nilsson, MD, PhD
study chair · Department of Endocrinology, University of Gothenburg
Kristjan Karason, MD, PhD
principal investigator · Department of Molecular and Clinical Medicine at University of Gothenburg

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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