ObesityNCT00700843
Long-Term Follow-up of Ohio State University Medical Center (OSUMC) Bariatric Patients
An observational study of Obesity, run by Ohio State University at 1 site in United States.
Trial summary
Obtain long-term follow-up results for bariatric patients who underwent medical management or surgery for treatment of morbid obesity by Ohio State University Medical Center (OSUMC). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Obesity
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Aug 2011
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults who participated in the bariatric program at OSUMC ten or more years ago, including bariatric surgery.
Who may be able to join
- Adult
- Treated by OSUMC physicians for obesity
- Informed Consent
Who cannot join
- Informed consent not given
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Obtain long-term follow-up results for bariatric patients who underwent medical management or surgery for treatment of morbid obesity by Ohio State University Medical Center (OSUMC).
Read the detailed description
The purpose of this study is to obtain long-term follow-up results for bariatric patients who underwent medical management or surgery for treatment of morbid obesity by Ohio State University Medical Center (OSUMC) surgeons during the late 1970s, 1980s, and 1990s. Our hypothesis is that surgical intervention for treatment of morbid obesity leads to sustained weight loss and decreased obesity-related morbidity and mortality.
- Conditions
- Obesity
- Keywords
- bariatric surgery, long term follow up, gastric partitioning surgery, Roux-en-Y gastric bypass surgery, obesity
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure to lose and maintain loss of > or equal to 50% of excess body weight will be considered failure of the bariatric surgery.
Measured: 10 or more years after surgery
Secondary outcomes (1)
The need for additional surgical or other intervention for treatment of morbid obesity following bariatric surgery will be considered failure of the surgery.
Measured: 10 or more years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startApr 2008
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: Difficulty recruiting
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.
- More trials run by Ohio State UniversityThe 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 only
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bradley Needleman, Ohio State University
- Investigators
- Bradley J Needleman, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700843
- Sponsor's protocol ID
- 2008H0008
- Status last verified
- May 2015
- First submitted
- 17 Jun 2008
- Last updated
- 15 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Follow-up of Ohio State University Medical Center (OSUMC) Bariatric Patients
- ClinicalTrials.gov ID
- NCT00700843
- Acronym / sponsor ID
- 2008H0008
- Conditions
- Obesity
- Keywords
- bariatric surgery, long term follow up, gastric partitioning surgery, Roux-en-Y gastric bypass surgery, obesity
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 19 Jun 2008 (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.
Obtain long-term follow-up results for bariatric patients who underwent medical management or surgery for treatment of morbid obesity by Ohio State University Medical Center (OSUMC).
Detailed description
The purpose of this study is to obtain long-term follow-up results for bariatric patients who underwent medical management or surgery for treatment of morbid obesity by Ohio State University Medical Center (OSUMC) surgeons during the late 1970s, 1980s, and 1990s. Our hypothesis is that surgical intervention for treatment of morbid obesity leads to sustained weight loss and decreased obesity-related morbidity and mortality.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who participated in the bariatric program at OSUMC ten or more years ago, including bariatric surgery.
Key inclusion criteria (3 listed)
- Adult
- Treated by OSUMC physicians for obesity
- Informed Consent
Key exclusion criteria (1 listed)
- Informed consent not given
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
Failure to lose and maintain loss of > or equal to 50% of excess body weight will be considered failure of the bariatric surgery.
Time frame: 10 or more years after surgery
1 secondary outcome
The need for additional surgical or other intervention for treatment of morbid obesity following bariatric surgery will be considered failure of the surgery.
Time frame: 10 or more years after surgery
Results and safety
The study was stopped early (reason given: Difficulty recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
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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.
Bradley J Needleman, MD principal investigator
Ohio State University
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, run by Ohio State 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 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: stopped early, as of the sponsor's last update on 15 May 2015. 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 stopped early (reason given: Difficulty recruiting). Results are not available in the source record.
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?
Failure to lose and maintain loss of > or equal to 50% of excess body weight will be considered failure of the bariatric surgery. (time frame: 10 or more years after 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 15 May 2015.