n-3 Polyunsaturated Fatty Acids in Obesity

NCT00760760 | Completed Phase 2

• 2 other identifiers: PUFA-ATI1OeNB12735
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Adipose Tissue Inflammation; Morbid Obesity

Outcome Measures

Primary Outcomes (1)

• Adipose tissue inflammation

  Eight weeks of treatment

Secondary Outcomes (2)

• Metabolic control

  Eight weeks of treatment

• Dependence of effects on Pparg polymorphisms

  Eight weeks of treatment

Study Arms (2)

n-3 PUFA

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

Drug: control

Interventions

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

4g daily, 8 weeks

Also known as: Omacor®

n-3 PUFA

control DRUG

equivalent amount of fat as butter

Control

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-diabetic morbidly obese patients (BMI \> 40 kg/m2) supposed to undergo bariatric surgery
• Age 20-65 yrs

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead
• National Bank of Austria: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (2)

• Itariu BK, Zeyda M, Leitner L, Marculescu R, Stulnig TM. Treatment with n-3 polyunsaturated fatty acids overcomes the inverse association of vitamin D deficiency with inflammation in severely obese patients: a randomized controlled trial. PLoS One. 2013;8(1):e54634. doi: 10.1371/journal.pone.0054634. Epub 2013 Jan 25.

  PMID: 23372745 DERIVED

• Itariu BK, Zeyda M, Hochbrugger EE, Neuhofer A, Prager G, Schindler K, Bohdjalian A, Mascher D, Vangala S, Schranz M, Krebs M, Bischof MG, Stulnig TM. Long-chain n-3 PUFAs reduce adipose tissue and systemic inflammation in severely obese nondiabetic patients: a randomized controlled trial. Am J Clin Nutr. 2012 Nov;96(5):1137-49. doi: 10.3945/ajcn.112.037432. Epub 2012 Oct 3.

  PMID: 23034965 DERIVED

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Omacor

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas M Stulnig, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 25, 2008
• First Posted: September 26, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2014
• Study Completion: March 1, 2016
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

AU (1)