Morbid ObesityNCT00558532
Omega-3 Fatty Acid Status in Morbid Obesity Before and After Surgical Treatment
An observational study of Morbid Obesity and Cardiovascular Disease, run by University of Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Morbid Obesity, Cardiovascular Disease, Fatty Acid Levels
- What is being tested?
- Bariatric Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Nov 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Surgical group candidates must be undergoing surgery for morbid obesity, abdominoplasty or other abdominal operation.
- Must have adequate venous access.
Who cannot join
- Insufficient venous access
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Morbid Obesity, Cardiovascular Disease, Fatty Acid Levels
- Being tested
- Bariatric Surgery
- Keywords
- Morbid obesity, Omega-3 fatty acid levels
- Medical subject headings
- Obesity, Morbid, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric SurgeryProcedure or surgery
Open roux-en-Y gastric bypass, open banded sleeve gastrectomy, abdominoplasty, other abdominal surgery
| Study group | Role | What they receive |
|---|---|---|
| Surgical | Those subjects undergoing bariatric surgery or abdominal surgery following a previous bariatric surgery. Receives: Procedure: Bariatric Surgery | |
| Control | Volunteers who have dietary habits similar to the subjects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Omega-3 Fatty acid levels in whole blood, plasma and abdominal fat sample
Measured: Within 3 months of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionNov 2008
- Study completionNov 2008
Why it stopped: Investigator Retired.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J. Wesley Alexander, University of Cincinnati
- Investigators
- J. W. Alexander, M.D., Principal investigator, UC Surgeons Center fo Surgical Weight Loss/ University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00558532
- Sponsor's protocol ID
- 07-66
- Status last verified
- Jun 2016
- First submitted
- 14 Nov 2007
- Last updated
- 13 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acid Status in Morbid Obesity Before and After Surgical Treatment
- ClinicalTrials.gov ID
- NCT00558532
- Acronym / sponsor ID
- 07-66
- Conditions
- Morbid Obesity, Cardiovascular Disease, Fatty Acid Levels
- Keywords
- Morbid obesity, Omega-3 fatty acid levels
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Investigator Retired.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 15 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical | – | Procedure: Bariatric SurgeryThose subjects undergoing bariatric surgery or abdominal surgery following a previous bariatric surgery. |
| Control | – | –Volunteers who have dietary habits similar to the subjects. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Surgical group candidates must be undergoing surgery for morbid obesity, abdominoplasty or other abdominal operation.
- Must have adequate venous access.
Key exclusion criteria (1 listed)
- Insufficient venous access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric SurgeryOpen roux-en-Y gastric bypass, open banded sleeve gastrectomy, abdominoplasty, other abdominal surgery | Procedure or surgery | Surgical |
Primary outcome
Omega-3 Fatty acid levels in whole blood, plasma and abdominal fat sample
Time frame: Within 3 months of surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. W. Alexander, M.D. principal investigator
UC Surgeons Center fo Surgical Weight Loss/ University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity and Cardiovascular Disease, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Omega-3 Fatty acid levels in whole blood, plasma and abdominal fat sample (time frame: Within 3 months of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2016.