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PUFA-ATI: n-3 Polyunsaturated Fatty Acids in Obesity

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT00760760
Collaborator
National Bank of Austria (Other)
55
Enrollment
1
Location
2
Arms
90
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA)
  • Drug: control
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
55 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Impact of n-3 Polyunsaturated Fatty Acids on Adipose Tissue Inflammation in Morbidly Obese Patients
Study Start Date :
Sep 1, 2008
Actual Primary Completion Date :
Sep 1, 2014
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: n-3 PUFA

Drug: reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA)
4g daily, 8 weeks
Other Names:
  • Omacor®

    		•
    Placebo Comparator: Control

    Drug: control
    equivalent amount of fat as butter

    Outcome Measures

    Primary Outcome Measures

    1. Adipose tissue inflammation [Eight weeks of treatment]

    Secondary Outcome Measures

    1. Metabolic control [Eight weeks of treatment]

    2. Dependence of effects on Pparg polymorphisms [Eight weeks of treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thomas M Stulnig, Associate Professor, Medical University of Vienna
    ClinicalTrials.gov Identifier:
    NCT00760760
    Other Study ID Numbers:
    • PUFA-ATI1
    • OeNB12735
    First Posted:
    Sep 26, 2008
    Last Update Posted:
    Mar 16, 2016
    Last Verified:
    Mar 1, 2016
    Additional relevant MeSH terms:
    Obesity
    Obesity, Morbid
    Inflammation

    Study Results

    No Results Posted as of Mar 16, 2016