Adipose Tissue InflammationPhase 2PUFA-ATINCT00760760
n-3 Polyunsaturated Fatty Acids in Obesity
A Phase 2 study testing reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA) in people with Adipose Tissue Inflammation and Morbid Obesity, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Inflammation in the adipose (fat) tissue is an important condition leading to metabolic derangements and cardiovascular disease in obese patients. n-3 polyunsaturated fatty acids exert anti-inflammatory effects and prevent adipose tissue inflammation in rodent obesity. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Adipose Tissue Inflammation, Morbid Obesity
- What is being tested?
- reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2008to Mar 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-diabetic morbidly obese patients (BMI > 40 kg/m2) supposed to undergo bariatric surgery
- Age 20-65 yrs
Who cannot join
- Acute illness within the last two week
- Known diabetes mellitus or current anti-diabetic medication
- Acquired immunodeficiency (HIV infection)
- Hepatitis or other significant liver disease
- Severe or untreated cardiovascular, renal, pulmonary disease
- Untreated or inadequately treated clinically significant thyroid disease
Show all 11Show fewer
- Anemia
- Active malignant disease
- Inborn or acquired bleeding disorder including warfarin treatment
- Pregnancy or breast feeding
- Drug intolerability that prohibits the use of the study drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of n-3 Polyunsaturated Fatty Acids on Adipose Tissue Inflammation in Morbidly Obese Patients
Inflammation in the adipose (fat) tissue is an important condition leading to metabolic derangements and cardiovascular disease in obese patients. n-3 polyunsaturated fatty acids exert anti-inflammatory effects and prevent adipose tissue inflammation in rodent obesity. This study tests the hypothesis that n-3 polyunsaturated fatty acids ameliorate adipose tissue inflammation in morbidly obese patients.
- Conditions
- Adipose Tissue Inflammation, Morbid Obesity
- Being tested
- reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA), control
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA)Drug
Also called Omacor®
4g daily, 8 weeks
controlDrug
equivalent amount of fat as butter
| Study group | Role | What they receive |
|---|---|---|
| n-3 PUFA | Experimental | Not described Receives: Drug: reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA) |
| Control | Placebo comparator | Not described Receives: Drug: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adipose tissue inflammation
Measured: Eight weeks of treatment
Secondary outcomes (2)
Metabolic control
Measured: Eight weeks of treatment
Dependence of effects on Pparg polymorphisms
Measured: Eight weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2014
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adipose Tissue InflammationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- National Bank of Austria
- Responsible party
- Principal investigator, Thomas M Stulnig, Medical University of Vienna
- Investigators
- Thomas M Stulnig, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760760
- Sponsor's protocol ID
- PUFA-ATI1
- Other IDs
- OeNB12735
- Acronym
- PUFA-ATI
- Status last verified
- Mar 2016
- First submitted
- 25 Sep 2008
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Itariu BK, Zeyda M, Leitner L, Marculescu R, Stulnig TM. Treatment with n-3 polyunsaturated fatty acids overcomes the inverse association of vitamin D deficiency with inflammation in severely obese patients: a randomized controlled trial. PLoS One. 2013;8(1):e54634. doi: 10.1371/journal.pone.0054634. Epub 2013 Jan 25.
PubMed 23372745Itariu BK, Zeyda M, Hochbrugger EE, Neuhofer A, Prager G, Schindler K, Bohdjalian A, Mascher D, Vangala S, Schranz M, Krebs M, Bischof MG, Stulnig TM. Long-chain n-3 PUFAs reduce adipose tissue and systemic inflammation in severely obese nondiabetic patients: a randomized controlled trial. Am J Clin Nutr. 2012 Nov;96(5):1137-49. doi: 10.3945/ajcn.112.037432. Epub 2012 Oct 3.
PubMed 23034965
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of n-3 Polyunsaturated Fatty Acids on Adipose Tissue Inflammation in Morbidly Obese Patients
- ClinicalTrials.gov ID
- NCT00760760
- Acronym / sponsor ID
- PUFA-ATI / PUFA-ATI1
- Conditions
- Adipose Tissue Inflammation, Morbid Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- National Bank of Austria
- Study start
- Sep 2008
- Primary completion
- Sep 2014 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 26 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Inflammation in the adipose (fat) tissue is an important condition leading to metabolic derangements and cardiovascular disease in obese patients. n-3 polyunsaturated fatty acids exert anti-inflammatory effects and prevent adipose tissue inflammation in rodent obesity. This study tests the hypothesis that n-3 polyunsaturated fatty acids ameliorate adipose tissue inflammation in morbidly obese patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| n-3 PUFA | Experimental | Drug: reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA) |
| Control | Placebo comparator | Drug: control |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Non-diabetic morbidly obese patients (BMI > 40 kg/m2) supposed to undergo bariatric surgery
- Age 20-65 yrs
Key exclusion criteria (11 listed)
- Acute illness within the last two week
- Known diabetes mellitus or current anti-diabetic medication
- Acquired immunodeficiency (HIV infection)
- Hepatitis or other significant liver disease
- Severe or untreated cardiovascular, renal, pulmonary disease
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 |
|---|---|---|
| reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA)Also: Omacor®4g daily, 8 weeks | Drug | n-3 PUFA |
| controlequivalent amount of fat as butter | Drug | Control |
Primary outcome
Adipose tissue inflammation
Time frame: Eight weeks of treatment
2 secondary outcomes
Metabolic control
Time frame: Eight weeks of treatment
Dependence of effects on Pparg polymorphisms
Time frame: Eight weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Derived from this study: PubMed 23372745Itariu BK, Zeyda M, Leitner L, Marculescu R, Stulnig TM. Treatment with n-3 polyunsaturated fatty acids overcomes the inverse association of vitamin D deficiency with inflammation in severely obese patients: a randomized controlled trial. PLoS One. 2013;8(1):e54634. doi: 10.1371/journal.pone.0054634. Epub 2013 Jan 25.
- Derived from this study: PubMed 23034965Itariu BK, Zeyda M, Hochbrugger EE, Neuhofer A, Prager G, Schindler K, Bohdjalian A, Mascher D, Vangala S, Schranz M, Krebs M, Bischof MG, Stulnig TM. Long-chain n-3 PUFAs reduce adipose tissue and systemic inflammation in severely obese nondiabetic patients: a randomized controlled trial. Am J Clin Nutr. 2012 Nov;96(5):1137-49. doi: 10.3945/ajcn.112.037432. Epub 2012 Oct 3.
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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.
Thomas M Stulnig, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA) in people with Adipose Tissue Inflammation and Morbid Obesity, run by Medical University of Vienna at 1 site in Austria.
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 2 inclusion and 11 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 16 Mar 2016. 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 Austria. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adipose tissue inflammation (time frame: Eight weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00760760, which also lists 2 linked publications.
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 16 Mar 2016.