n-3 Polyunsaturated Fatty Acids in Obesity | NCT00760760

Studies
n-3 Polyunsaturated Fatty Acids in Obesity

NCT00760760

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Mar 16, 2016Estimated

Enrollment

55Actual

Phase

Phase 2

Conditions

Adipose Tissue Inflammation
Morbid Obesity

Interventions

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

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
OeNB12735

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Sep 2014Actual

Completion Date

Mar 2016Actual

First Submitted Date

Sep 25, 2008

First Submission Date that Met QC Criteria

Sep 25, 2008

First Posted Date

Sep 26, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2016

Last Update Posted Date

Mar 16, 2016Estimated

Name	Class
National Bank of Austria	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA)	Drug	4g daily, 8 weeks	n-3 PUFA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adipose tissue inflammation		Eight weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
Metabolic control		Eight weeks of treatment
Dependence of effects on Pparg polymorphisms		Eight weeks of treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas M Stulnig, MD	Medical University of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna		Vienna		1090	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23372745	Derived	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.
23034965

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders