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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Medical University of Vienna.
Recruitment status was  Active, not recruiting
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
  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:


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
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

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 September 11, 2014