ObesityNCT01130207
Microbes and Bariatric Surgery
An observational study of Obesity and Diabetes, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
The investigators will study people who are obese and will be treated by bariatric surgery. The investigators will test the hypothesis that some of the features of obesity are related to the bacteria in the gastro-intestinal tract. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Diabetes, Periodontal Disease
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Aug 2013
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with obesity who are already accepted for treatment by bariatric surgery in Syracuse NY
Who may be able to join
- Ages 18-65
- Will undergo bariatric surgery for treatment of obesity in Syracuse NY
- Willingness to participate
Who cannot join
- Any previous gastrointestinal surgery
- Use of antibiotics in the previous 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Upstate Medical University
Syracuse, New York, 13210
About this study
Official title: Effects of Bariatric Surgery on the Gastro-intestinal Microflora
The investigators will study people who are obese and will be treated by bariatric surgery. The investigators will test the hypothesis that some of the features of obesity are related to the bacteria in the gastro-intestinal tract.
- Conditions
- Obesity, Diabetes, Periodontal Disease
- Keywords
- Obesity, Diabetes, Periodontal disease
- Medical subject headings
- Obesity, Diabetes Mellitus, Periodontal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in microflora after bariatric surgery
Specific differences were measured in oral and intestinal bacteria immediately after surgery.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startMay 2010
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward J. Shillitoe, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01130207
- Sponsor's protocol ID
- Microbes and Bariatric Surgery
- Status last verified
- Nov 2014
- First submitted
- 24 May 2010
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bariatric Surgery on the Gastro-intestinal Microflora
- ClinicalTrials.gov ID
- NCT01130207
- Acronym / sponsor ID
- Microbes and Bariatric Surgery
- Conditions
- Obesity, Diabetes, Periodontal Disease
- Keywords
- Obesity, Diabetes, Periodontal disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 25 May 2010 (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 investigators will study people who are obese and will be treated by bariatric surgery. The investigators will test the hypothesis that some of the features of obesity are related to the bacteria in the gastro-intestinal tract.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with obesity who are already accepted for treatment by bariatric surgery in Syracuse NY
Key inclusion criteria (3 listed)
- Ages 18-65
- Will undergo bariatric surgery for treatment of obesity in Syracuse NY
- Willingness to participate
Key exclusion criteria (2 listed)
- Any previous gastrointestinal surgery
- Use of antibiotics in the previous 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in microflora after bariatric surgery
Time frame: Six months
Specific differences were measured in oral and intestinal bacteria immediately after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Obesity and Diabetes, run by State University of New York - Upstate Medical University 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 19 Nov 2014. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in microflora after bariatric surgery (time frame: Six months). 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 19 Nov 2014.