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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

National Bank of Austria

Information provided by:

Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT00760760

First received: September 25, 2008

Last updated: June 28, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 25, 2008

Last Updated Date

June 28, 2011

Start Date ^ICMJE

September 2008

Estimated Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Adipose tissue inflammation [ Time Frame: Eight weeks of treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Adipose tissue inflammation [ Time Frame: end of treatment period ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00760760 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Metabolic control [ Time Frame: Eight weeks of treatment ] [ Designated as safety issue: No ]
Dependence of effects on Pparg polymorphisms [ Time Frame: Eight weeks of treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Metabolic control [ Time Frame: end of treatment period ] [ Designated as safety issue: No ]
Dependence of effects on Pparg polymorphisms [ Time Frame: end of treatment period ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

n-3 Polyunsaturated Fatty Acids in Obesity

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science

Condition ^ICMJE

Adipose Tissue Inflammation
Morbid Obesity

Intervention ^ICMJE

Drug: reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA)
4g daily, 8 weeks

Other Name: Omacor®
Drug: control
equivalent amount of fat as butter

Study Arm (s)

Experimental: n-3 PUFA
Intervention: Drug: reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA)
Placebo Comparator: Control
Intervention: Drug: control

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

December 2011

Estimated Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria

Administrative Information

NCT Number ^ICMJE

NCT00760760

Other Study ID Numbers ^ICMJE

PUFA-ATI1, OeNB12735

Has Data Monitoring Committee

Responsible Party

Thomas M Stulnig, MD, Medical University of Vienna

Study Sponsor ^ICMJE

Medical University of Vienna

Collaborators ^ICMJE

National Bank of Austria

Investigators ^ICMJE

Principal Investigator:

Thomas M Stulnig, MD

Medical University of Vienna

Information Provided By

Medical University of Vienna

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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