NCT00558532

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 15, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

June 13, 2016

Status Verified

June 1, 2016

Enrollment Period

1.1 years

First QC Date

November 14, 2007

Last Update Submit

June 10, 2016

Conditions

Morbid ObesityCardiovascular DiseaseFatty Acid Levels

Keywords

Morbid obesityOmega-3 fatty acid levels

Outcome Measures

Primary Outcomes (1)

  • Omega-3 Fatty acid levels in whole blood, plasma and abdominal fat sample

    Within 3 months of surgery

Study Arms (2)

Surgical

Those subjects undergoing bariatric surgery or abdominal surgery following a previous bariatric surgery.

Procedure: Bariatric Surgery

Control

Volunteers who have dietary habits similar to the subjects.

Interventions

Bariatric SurgeryPROCEDURE

Open roux-en-Y gastric bypass, open banded sleeve gastrectomy, abdominoplasty, other abdominal surgery

Surgical

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Insufficient venous access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma, fat tissue

MeSH Terms

Conditions

Obesity, MorbidCardiovascular Diseases

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • J. W. Alexander, M.D.

    UC Surgeons Center fo Surgical Weight Loss/ University of Cincinnati

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emeritus

Study Record Dates

First Submitted

November 14, 2007

First Posted

November 15, 2007

Study Start

October 1, 2007

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

June 13, 2016

Record last verified: 2016-06

Locations

US(1)