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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Bank of Austria
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00760760
First received: September 25, 2008
Last updated: June 28, 2011
Last verified: June 2011
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:

MedlinePlus related topics: Obesity
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
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 2011 (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
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
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

No publications provided by Medical University of Vienna

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

Responsible Party: Thomas M Stulnig, MD, 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: June 28, 2011
Health Authority: Austria: Federal Office for Safety in Health Care

Additional relevant MeSH terms:
Inflammation
Obesity
Obesity, Morbid
Pathologic Processes
Overnutrition
 Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013