- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00760760
n-3 Polyunsaturated Fatty Acids in Obesity (PUFA-ATI)
March 14, 2016 updated by: Thomas M Stulnig, Medical University of Vienna
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Vienna, Austria, 1090
- Medical University of Vienna
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Non-diabetic morbidly obese patients (BMI > 40 kg/m2) supposed to undergo bariatric surgery
- Age 20-65 yrs
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control
|
equivalent amount of fat as butter
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Experimental: n-3 PUFA
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4g daily, 8 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adipose tissue inflammation
Time Frame: Eight weeks of treatment
|
Eight weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Metabolic control
Time Frame: Eight weeks of treatment
|
Eight weeks of treatment
|
Dependence of effects on Pparg polymorphisms
Time Frame: Eight weeks of treatment
|
Eight weeks of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas M Stulnig, MD, Medical University of Vienna
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Itariu 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. Erratum In: Am J Clin Nutr. 2020 Nov 11;112(5):1405.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
September 25, 2008
First Submitted That Met QC Criteria
September 25, 2008
First Posted (Estimate)
September 26, 2008
Study Record Updates
Last Update Posted (Estimate)
March 16, 2016
Last Update Submitted That Met QC Criteria
March 14, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PUFA-ATI1
- OeNB12735
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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