Abdominal ObesityPhase 3RIVIERANCT01068626
Rosuvastatin in Visceral Adiposity
A Phase 3 study testing Rosuvastatin in people with Abdominal Obesity, run by Göteborg University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, men only
- Conditions the study is for
- Abdominal Obesity
- What is being tested?
- Rosuvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteSweden
- Study dates
- May 2006to Dec 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients between 40 and 65 years of age.
- Abdominal obesity
- Dyslipidemia
- Written informed consent.
Who cannot join
- Uncontrolled hypertension
- Diabetes mellitus
- Severe liver disease
- Severely reduced renal function
- Uncontrolled endocrine disorders
- History of or ongoing malignant disease
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Molecular and Clinical Medicine, Sahlgrenska Academy at University of Gothernburg
Gothenburg, 413 45
About this study
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
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.
- Conditions
- Abdominal Obesity
- Being tested
- Rosuvastatin, Placebo for rosuvastatin
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor®
10 mg once daily
Placebo for rosuvastatinDrug
once daily
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Active comparator | Not described Receives: Drug: Rosuvastatin |
| Placebo for Rosuvastatin | Placebo comparator | Not described Receives: Drug: Placebo for rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visceral Adipose Tissue Area Measured by Computed Tomography.
Measured: 6 months
Secondary outcomes (5)
Change in Subcutaneous Adipose Tissue Area
Measured: 6 months
Change in the Ratio Between Intra-abdominal and Subcutaneous Tissue Area Measured by CT.
Measured: 6 months
Change in Hepatic Fat Infiltration Measured by CT.
Measured: 6 months
Change in Body Weight
Measured: 6 months
Change in LDL
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2010 (estimated)
- Study startMay 2006
- Primary completionOct 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Abdominal ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Responsible party
- Sponsor
- Investigators
- John-Olov Jansson, Prof, Study chair, Department of Endocrinology, University of GothenburgClaes Ohlsson, Professor, Study chair, Department of Clinical Pharmocology, University of GothenburgAnna Nilsson, MD, PhD, Study chair, Department of Endocrinology, University of GothenburgKristjan Karason, MD, PhD, Principal investigator, Department of Molecular and Clinical Medicine at University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068626
- Sponsor's protocol ID
- 990312
- Acronym
- RIVIERA
- Status last verified
- Aug 2015
- First submitted
- 12 Feb 2010
- Last updated
- 24 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01068626
- Acronym / sponsor ID
- RIVIERA / 990312
- Conditions
- Abdominal Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Study start
- May 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 15 Feb 2010 (estimated)
- Results
- Posted 2 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Active comparator | Drug: Rosuvastatin |
| Placebo for Rosuvastatin | Placebo comparator | Drug: Placebo for rosuvastatin |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male patients between 40 and 65 years of age.
- Abdominal obesity
- Dyslipidemia
- Written informed consent.
Key exclusion criteria (16 listed)
- Uncontrolled hypertension
- Diabetes mellitus
- Severe liver disease
- Severely reduced renal function
- Uncontrolled endocrine disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RosuvastatinAlso: Crestor®10 mg once daily | Drug | Rosuvastatin |
| Placebo for rosuvastatinonce daily | Drug | Placebo for Rosuvastatin |
Primary outcome
Change in Visceral Adipose Tissue Area Measured by Computed Tomography.
Time frame: 6 months
5 secondary outcomes
Change in Subcutaneous Adipose Tissue Area
Time frame: 6 months
Change in the Ratio Between Intra-abdominal and Subcutaneous Tissue Area Measured by CT.
Time frame: 6 months
Change in Hepatic Fat Infiltration Measured by CT.
Time frame: 6 months
Change in Body Weight
Time frame: 6 months
Change in LDL
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rosuvastatin in people with Abdominal Obesity, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visceral Adipose Tissue Area Measured by Computed Tomography. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2015; AzTrials last refreshed its copy on 31 Oct 2026.