n-3 Polyunsaturated Fatty Acids in Obesity

Phase 2

Completed

• Conditions: Adipose Tissue Inflammation; Morbid Obesity
• Interventions: Drug: control; Drug: reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA)

• Registration Number: NCT00760760
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-25
• Study First Submitted QC: 2008-09-25
• Study First Posted: 2008-09-26
• Primary Completion: 2014-09
• Status Verified: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-14
• Last Update Posted: 2016-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	control	-
n-3 PUFA	reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA)	-

Primary Outcome Measures

Name	Time	Method
Adipose tissue inflammation	Eight weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Metabolic control	Eight weeks of treatment
Dependence of effects on Pparg polymorphisms	Eight weeks of treatment

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria