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

This study has been withdrawn prior to enrollment.
(Investigator Retired.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00558532
First Posted: November 15, 2007
Last Update Posted: June 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
J. Wesley Alexander, University of Cincinnati
  Purpose
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.

Condition Intervention
Morbid Obesity Cardiovascular Disease Fatty Acid Levels Procedure: Bariatric Surgery

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Omega-3 Fatty Acid Status in Morbid Obesity Before and After Surgical Treatment

Resource links provided by NLM:


Further study details as provided by J. Wesley Alexander, University of Cincinnati:

Primary Outcome Measures:
  • Omega-3 Fatty acid levels in whole blood, plasma and abdominal fat sample [ Time Frame: Within 3 months of surgery ]

Biospecimen Retention:   Samples With DNA
Whole blood, plasma, fat tissue

Enrollment: 0
Study Start Date: October 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00558532


Locations
United States, Ohio
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: J. W. Alexander, M.D. UC Surgeons Center fo Surgical Weight Loss/ University of Cincinnati
  More Information

Responsible Party: J. Wesley Alexander, Emeritus, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00558532     History of Changes
Other Study ID Numbers: 07-66
First Submitted: November 14, 2007
First Posted: November 15, 2007
Last Update Posted: June 13, 2016
Last Verified: June 2016

Keywords provided by J. Wesley Alexander, University of Cincinnati:
Morbid obesity
Omega-3 fatty acid levels

Additional relevant MeSH terms:
Obesity
Cardiovascular Diseases
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms