Back to resultsn-3 Polyunsaturated Fatty Acids in Obesity (PUFA-ATI)
Primary Purpose
Adipose Tissue Inflammation, Morbid Obesity
Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA)
control
Sponsored by
About this trial
This is an interventional basic science trial for Adipose Tissue Inflammation
Eligibility Criteria
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
Sites / Locations
- Medical University of Vienna
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
n-3 PUFA
Control
Arm Description
Outcomes
Primary Outcome Measures
Adipose tissue inflammation
Secondary Outcome Measures
Metabolic control
Dependence of effects on Pparg polymorphisms
Full Information
NCT ID
NCT00760760
First Posted
September 25, 2008
Last Updated
March 14, 2016
Sponsor
Medical University of Vienna
Collaborators
National Bank of Austria
1. Study Identification
Unique Protocol Identification Number
NCT00760760
Brief Title
n-3 Polyunsaturated Fatty Acids in Obesity
Acronym
PUFA-ATI
Official Title
Impact of n-3 Polyunsaturated Fatty Acids on Adipose Tissue Inflammation in Morbidly Obese Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
Collaborators
National Bank of Austria
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. This study tests the hypothesis that n-3 polyunsaturated fatty acids ameliorate adipose tissue inflammation in morbidly obese patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adipose Tissue Inflammation, Morbid Obesity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
n-3 PUFA
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA)
Other Intervention Name(s)
Omacor®
Intervention Description
4g daily, 8 weeks
Intervention Type
Drug
Intervention Name(s)
control
Intervention Description
equivalent amount of fat as butter
Primary Outcome Measure Information:
Title
Adipose tissue inflammation
Time Frame
Eight weeks of treatment
Secondary Outcome Measure Information:
Title
Metabolic control
Time Frame
Eight weeks of treatment
Title
Dependence of effects on Pparg polymorphisms
Time Frame
Eight weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas M Stulnig, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
23372745
Citation
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.
Results Reference
derived
PubMed Identifier
23034965
Citation
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.
Results Reference
derived
Learn more about this trial
n-3 Polyunsaturated Fatty Acids in Obesity
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