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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00760760
First Posted: September 26, 2008
Last Update Posted: March 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Bank of Austria
Information provided by (Responsible Party):
Thomas M Stulnig, Medical University of Vienna
September 25, 2008
September 26, 2008
March 16, 2016
September 2008
September 2014   (Final data collection date for primary outcome measure)
Adipose tissue inflammation [ Time Frame: Eight weeks of treatment ]
Adipose tissue inflammation [ Time Frame: end of treatment period ]
Complete list of historical versions of study NCT00760760 on ClinicalTrials.gov Archive Site
  • Metabolic control [ Time Frame: Eight weeks of treatment ]
  • Dependence of effects on Pparg polymorphisms [ Time Frame: Eight weeks of treatment ]
  • Metabolic control [ Time Frame: end of treatment period ]
  • Dependence of effects on Pparg polymorphisms [ Time Frame: end of treatment period ]
Not Provided
Not Provided
 
n-3 Polyunsaturated Fatty Acids in Obesity
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
  • Adipose Tissue Inflammation
  • Morbid Obesity
  • Drug: reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA)
    4g daily, 8 weeks
    Other Name: Omacor®
  • Drug: control
    equivalent amount of fat as butter
  • Experimental: n-3 PUFA
    Intervention: Drug: reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA)
  • Placebo Comparator: Control
    Intervention: Drug: control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
March 2016
September 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
 
NCT00760760
PUFA-ATI1
OeNB12735
No
Not Provided
Not Provided
Thomas M Stulnig, Medical University of Vienna
Medical University of Vienna
National Bank of Austria
Principal Investigator: Thomas M Stulnig, MD Medical University of Vienna
Medical University of Vienna
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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