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

Medical University of Vienna

Status and phase: Completed; Phase 2

Conditions: Morbid Obesity; Adipose Tissue Inflammation

Treatments: Drug: control; Drug: reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA)

Study type: Interventional

Funder types: Other

Identifiers

NCT00760760

OeNB12735

PUFA-ATI1

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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55 participants in 2 patient groups, including a placebo group

n-3 PUFA

Experimental group

Treatment:

Drug: reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA)

Control

Placebo Comparator group

Treatment:

Drug: control