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

Conditions: morbid obesity
MedDRA version: 8.1Level: LLTClassification code 10027966Term: Morbid obesity

Registration Number: EUCTR2006-005287-94-AT

Lead Sponsor: Medizinische Universität Wien

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

non-diabetic morbidly obese patients (BMI > 40 kg/m2) supposed to undergo bariatric surgery; age 20-65 yrs;
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Acute illness within the last two weeks

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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: effect of n-3 polyunsaturated fatty acids (n-3 PUFA; Omacor®) on visceral adipose tissue inflammation;Secondary Objective: Impact of n-3 PUFA on metabolic control<br><br>Determination of treatment compliance and n-3 PUFA accumulation in tissues<br><br>Impact of n-3 PUFA on adipose tissue lipid mediators<br><br>Impact of n-3 PUFA on metabolic regulation<br><br>;Primary end point(s): change in inflammatory parameters in visceral adipose tissue

Secondary Outcome Measures