Omega-3 Fatty Acid Status in Morbid Obesity Before and After Surgical Treatment

June 10, 2016 updated by: J. Wesley Alexander, University of Cincinnati
The purpose of this study is to determine the concentration of omega-3 fatty acids in plasma, blood and abdominal fat before and after bariatric surgery to provide guidance for future studies.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The omega-3 fatty acids are essential for human growth, development and well-being. Numerous studies have shown that a relatively high intake of the omega-3 fatty acids are beneficial in brain and visual development, psychiatric disorders, rheumatic disorders, inflammatory responses and cardiovascular disease. As an example, low levels of tissue omega-3 fatty acids are associated with a markedly higher rate of death from cardiac causes compared to patients with relatively high concentrations of the omega-3 fatty acids. Obese patients often have an unhealthy dietary intake and evidence of increased inflammatory processes. After a gastric bypass patients will have decreased absorption of fats from the gastrointestinal tract and may become fatty acid deficient. While gastric bypass may decrease death from cardiovascular disease in morbidly obese patients, cardiovascular disease is still the most common cause of death after a gastric bypass. There are numerous nutritional deficiencies which occur after gastric bypass and many of these are well documented. However, there are no data concerning the plasma and tissue levels of omega-3 fatty acids in morbidly obese patients either before or after operation.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients undergoing an operation for morbid obesity will be candidates for inclusion in the study as will all candidates who are undergoing abdominoplasty or other abdominal operations post bariatric surgery.

Description

Inclusion Criteria:

  • Surgical group candidates must be undergoing surgery for morbid obesity, abdominoplasty or other abdominal operation.
  • Must have adequate venous access.

Exclusion Criteria:

  • Insufficient venous access

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgical
Those subjects undergoing bariatric surgery or abdominal surgery following a previous bariatric surgery.
Procedure: Bariatric Surgery
Open roux-en-Y gastric bypass, open banded sleeve gastrectomy, abdominoplasty, other abdominal surgery
Control
Volunteers who have dietary habits similar to the subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Omega-3 Fatty acid levels in whole blood, plasma and abdominal fat sample
Time Frame: Within 3 months of surgery
Within 3 months of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Investigators

  • Principal Investigator: J. W. Alexander, M.D., UC Surgeons Center fo Surgical Weight Loss/ University of Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

November 14, 2007

First Submitted That Met QC Criteria

November 14, 2007

First Posted (Estimate)

November 15, 2007

Study Record Updates

Last Update Posted (Estimate)

June 13, 2016

Last Update Submitted That Met QC Criteria

June 10, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-66

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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