n-3 Polyunsaturated Fatty Acids in Obesity

Morbid Obesity Clinical Trial

— PUFA-ATI  

Official title:

Impact of n-3 Polyunsaturated Fatty Acids on Adipose Tissue Inflammation in Morbidly Obese Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00760760
• Other study ID #: PUFA-ATI1
• Secondary ID: OeNB12735
• Status: Completed
• Phase: Phase 2
• First received: September 25, 2008
• Last updated: March 14, 2016
• Start date: September 2008
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 2016
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Adipose Tissue Inflammation
• Inflammation
• Morbid Obesity
• Obesity, Morbid

Intervention

Drug:
• reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA)
4g daily, 8 weeks
• control
equivalent amount of fat as butter

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	National Bank of Austria

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adipose tissue inflammation		Eight weeks of treatment	No
Secondary	Metabolic control		Eight weeks of treatment	No
Secondary	Dependence of effects on Pparg polymorphisms		Eight weeks of treatment	No