n-3 Polyunsaturated Fatty Acids in Obesity (PUFA-ATI)

This study has been completed.

Sponsor:

Collaborator:

National Bank of Austria

Information provided by (Responsible Party):

Thomas M Stulnig, Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT00760760

First received: September 25, 2008

Last updated: March 14, 2016

Last verified: March 2016

History of Changes

Purpose

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.

Condition	Intervention	Phase
Adipose Tissue Inflammation Morbid Obesity	Drug: reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA) Drug: control	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Basic Science
Official Title:	Impact of n-3 Polyunsaturated Fatty Acids on Adipose Tissue Inflammation in Morbidly Obese Patients

Resource links provided by NLM:

Drug Information available for: Omega-3 Fatty Acids

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

Adipose tissue inflammation [ Time Frame: Eight weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Metabolic control [ Time Frame: Eight weeks of treatment ] [ Designated as safety issue: No ]
Dependence of effects on Pparg polymorphisms [ Time Frame: Eight weeks of treatment ] [ Designated as safety issue: No ]


Enrollment:	55
Study Start Date:	September 2008
Study Completion Date:	March 2016
Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: n-3 PUFA	Drug: reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA) 4g daily, 8 weeks Other Name: Omacor®
Placebo Comparator: Control	Drug: control equivalent amount of fat as butter

Eligibility


Ages Eligible for Study:	20 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760760

Locations


Austria
Medical University of Vienna
Vienna, Austria, 1090

Sponsors and Collaborators

Medical University of Vienna

National Bank of Austria

Investigators


Principal Investigator:	Thomas M Stulnig, MD	Medical University of Vienna

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Thomas M Stulnig, Associate Professor, Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00760760 History of Changes
Other Study ID Numbers:	PUFA-ATI1 OeNB12735
Study First Received:	September 25, 2008
Last Updated:	March 14, 2016
Health Authority:	Austria: Federal Office for Safety in Health Care

Additional relevant MeSH terms:


Obesity Inflammation Obesity, Morbid Overnutrition Nutrition Disorders	Overweight Body Weight Signs and Symptoms Pathologic Processes

ClinicalTrials.gov processed this record on September 23, 2016

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