Morbid ObesityNCT01153308
Outcomes of Bariatric Surgery/UMMMC Bariatric Surgery Registry
An observational study of Morbid Obesity, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The purpose of this registry is to monitor and evaluate the efficacy, as well as safety, of bariatric surgery performed at UMass Memorial Medical Center, including laparoscopic gastric bypass surgery and laparoscopic gastric banding, in the surgical treatment of morbid obesity and associated co-morbidities such as… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Observational Study
- How many people
- 4,785 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Apr 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: UMMMC Bariatric Surgery Patients
Who may be able to join
- Must be scheduled for Bariatric Surgery @ UMMMC
Who cannot join
- Not scheduled for Bariatric Surgery @ UMMMC
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: Outcomes of Bariatric Surgery (UMMMC Bariatric Surgery Registry)
The purpose of this registry is to monitor and evaluate the efficacy, as well as safety, of bariatric surgery performed at UMass Memorial Medical Center, including laparoscopic gastric bypass surgery and laparoscopic gastric banding, in the surgical treatment of morbid obesity and associated co-morbidities such as type 2 diabetes, sleep apnea and cardiovascular disease.
Read the detailed description
See brief Summary
- Conditions
- Morbid Obesity
- Being tested
- Observational Study
- Keywords
- Morbid Obesity, Obesity, Weight Loss, Bariatric Surgery
- Medical subject headings
- Obesity, Morbid, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational StudyOther
This is an Observational study
| Study group | Role | What they receive |
|---|---|---|
| Bariatric Surgery Patients | Bariatric Surgery patients at UMass Memorial Medical Center Receives: Other: Observational Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss after surgery
Baseline weight is recorded preoperatively. Time points after surgery when weight is recorded are two weeks, six weeks, 6 months, 1 year, 18 months, 2 years, then annually on the anniversary date of surgery.
Measured: Preop, Postop, Six Months, and Annually
Secondary outcomes (1)
Resolution of Co-morbidities, such as Type 2 Diabetes, Sleep Apnea, Hypertension
Preoperatively co-morbidities of morbid obesity are recorded as well as treatment (ie: medications, CPAP machine). Resolution of co-morbidities postoperatively is measured/recorded for example by blood tests, sleep study, as well as changes or discontinuation of medications \&/or interventions.
Measured: Preop, Postop, Six Months, Annually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startApr 2005
- Primary completionApr 2015
- Study completionApr 2015
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 Massachusetts, WorcesterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,785 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John J Kelly, MD, Principal investigator, University of Massachusetts Medical School and UMass Memorial Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153308
- Sponsor's protocol ID
- H-11612
- Status last verified
- Aug 2015
- First submitted
- 21 Mar 2010
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Bariatric Surgery (UMMMC Bariatric Surgery Registry)
- ClinicalTrials.gov ID
- NCT01153308
- Acronym / sponsor ID
- H-11612
- Conditions
- Morbid Obesity
- Keywords
- Morbid Obesity, Obesity, Weight Loss, Bariatric Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,785 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 30 Jun 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 purpose of this registry is to monitor and evaluate the efficacy, as well as safety, of bariatric surgery performed at UMass Memorial Medical Center, including laparoscopic gastric bypass surgery and laparoscopic gastric banding, in the surgical treatment of morbid obesity and associated co-morbidities such as type 2 diabetes, sleep apnea and cardiovascular disease.
Detailed description
See brief Summary
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bariatric Surgery Patients | – | Other: Observational StudyBariatric Surgery patients at UMass Memorial Medical Center |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- UMMMC Bariatric Surgery Patients
Key inclusion criteria (1 listed)
- Must be scheduled for Bariatric Surgery @ UMMMC
Key exclusion criteria (1 listed)
- Not scheduled for Bariatric Surgery @ UMMMC
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 |
|---|---|---|
| Observational StudyThis is an Observational study | Other | Bariatric Surgery Patients |
Primary outcome
Weight Loss after surgery
Time frame: Preop, Postop, Six Months, and Annually
Baseline weight is recorded preoperatively. Time points after surgery when weight is recorded are two weeks, six weeks, 6 months, 1 year, 18 months, 2 years, then annually on the anniversary date of surgery.
1 secondary outcome
Resolution of Co-morbidities, such as Type 2 Diabetes, Sleep Apnea, Hypertension
Time frame: Preop, Postop, Six Months, Annually
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 Aug 2015.
- UMass Memorial Medical CenterLink provided by the sponsor.
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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.
John J Kelly, MD principal investigator
University of Massachusetts Medical School and UMass Memorial Medical Center
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, run by University of Massachusetts, Worcester 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 1 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: finished, as of the sponsor's last update on 19 Aug 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 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?
Weight Loss after surgery (time frame: Preop, Postop, Six Months, and Annually). 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 Aug 2015.