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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-005287-94-AT
Enrollment
Unknown
Registered
2008-03-17
Start date
2008-05-06
Completion date
Unknown
Last updated
2014-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

morbid obesity MedDRA version: 8.1 Level: LLT Classification code 10027966 Term: Morbid obesity

Interventions

Trade Name: Omacor Product Name: Omacor Product Code: 1–21530 Pharmaceutical Form: Capsule, soft INN or Proposed INN: Omacor
active substances: eicosapentaenoic acid ethyl ester, docosahexaenoic acid ethyl ester Concentration unit: g gram(s) Concentration type: equal Concentration number: 1-

Sponsors

Medizinische Universität Wien
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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 Determination of treatment compliance and n-3 PUFA accumulation in tissues Impact of n-3 PUFA on adipose tissue lipid mediators Impact of n-3 PUFA on metabolic regulation ;Primary end point(s): change in inflammatory parameters in visceral adipose tissue—

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026