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Completed

NCT Number: NCT00760760

n-3 Polyunsaturated Fatty Acids in Obesity

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.

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Key information

Conditions

Adipose Tissue Inflammation Body Weight Morbid Obesity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

4g daily, 8 weeks

Other names: Omacor®

Control

Drug

equivalent amount of fat as butter

Primary outcomes

  1. Adipose tissue inflammation

    Time frame: Eight weeks of treatment

Secondary outcomes

  1. Metabolic control

    Time frame: Eight weeks of treatment

  2. Dependence of effects on Pparg polymorphisms

    Time frame: Eight weeks of treatment

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

  • National Bank of Austria

Registry information

Official study title

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

Acronym: PUFA-ATI

Important dates

Study start
2008
Primary completion
2014
Study completion
2016
First posted
Sep 26, 2008
Registry last updated
Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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