ObesityNCT01044602
Metabolic Surgery Versus Medical Management for Resolution of Type II Diabetes
A study testing Laboratory evaluations, sleep study, Best Medical Management and Roux-en-Y gastric bypass surgery in people with Obesity and Type 2 Diabetes Mellitus, run by David Bradley MD at 1 site in United States.
Trial summary
Best medical management and gastric bypass surgery is a way to treat diabetes as part of regular medical care (standard of care). However, gastric bypass surgery is not a way to treat diabetes as part of regular medical care (standard of care). Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Obesity, Type 2 Diabetes Mellitus
- What is being tested?
- Laboratory evaluations, sleep study, Best Medical Management and Roux-en-Y gastric bypass surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jan 2014
- Phase
- Interventional
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 25 to 70
- BMI 35 or greater
- HbA1c>6.5%
- Stable weight
- Stable medications
Who cannot join
- Coagulopathy
- Liver cirrhosis
- C-peptide <1 ng/ml (off insulin)
- Diagnosis of severe eating disorder
- Untreated endocrine disorder
- Use of medication for weight loss in the past 6 months
Show all 16Show fewer
- Use of medication for weight loss in the last 6 months (with the exception of orlistat)
- Pregnancy
- Coagulopathy
- Liver cirrhosis
- Incurable, malignant, or debilitating disease
- Severe eating disorder
- Use of weight loss medication in the last 6 months, with the exception of orlistat
- Untreated endocrine disorder
- Pregnant
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: Metabolic Surgery vs. Medical Management for Resolution of Type II Diabetes: A Prospective Group Match Study
Best medical management and gastric bypass surgery is a way to treat diabetes as part of regular medical care (standard of care). However, gastric bypass surgery is not a way to treat diabetes as part of regular medical care (standard of care).
Read the detailed description
Best medical management and gastric bypass surgery are ways to treat obesity as part of regular medical care (standard of care). Best medical management is a way to treat diabetes as part of regular medical care (standard of care). However, gastric bypass surgery is not a way to treat diabetes as part of regular medical care (standard of care). But, studies suggest that diabetes gets better or goes away after gastric bypass surgery. This study is being done to find out if diabetes gets better or goes away completely after a patient has gastric bypass surgery as part of regular medical care (standard of care).
- Conditions
- Obesity, Type 2 Diabetes Mellitus
- Being tested
- Laboratory evaluations, sleep study, Best Medical Management, Roux-en-Y gastric bypass surgery
- Keywords
- Obesity, Type 2 Diabetes Mellitus, Roux-en-Y Gastric Bypass Surgery
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory evaluations, sleep studyOther
Fasting plasma glucose, liver function tests, chem-7, HOMA-IR, HBA1C, lipid profile, indirect calorimetry.
Best Medical ManagementOther
Standard of care.
Roux-en-Y gastric bypass surgeryProcedure or surgery
Surgical treatment.
| Study group | Role | What they receive |
|---|---|---|
| Best Medical Management | Active comparator | Patients elect to treat obesity and type 2 diabetes mellitus through best medical management. Receives: Other: Laboratory evaluations, sleep study; Other: Best Medical Management |
| Surgical Treatment | Active comparator | Patients with type 2 diabetes mellitus choice to treat obesity with Roux-en-Y gastric bypass. Receives: Other: Laboratory evaluations, sleep study; Procedure: Roux-en-Y gastric bypass surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of type 2 diabetes mellitus, determined by oral glucose tolerance test.
Measured: 2 years
Resolution of obesity co-morbidities including hypertension, OSA, and hyperlipidemia
Measured: 2 years
Secondary outcomes (3)
Improvement in glucose control
Measured: 2 years
Improvement in control of chronic co-morbidities
Measured: 2 years
Identify predictors of success with regard to improved co-morbidities and velocity of weight loss
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2014
- Study completionJan 2014
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Bradley MD
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Sponsor-investigator, David Bradley MD, Ohio State University
- Investigators
- Asem Ali, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044602
- Sponsor's protocol ID
- 2009H0282
- Other IDs
- MS vs. MM for DM2
- Status last verified
- Apr 2015
- First submitted
- 7 Jan 2010
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Surgery vs. Medical Management for Resolution of Type II Diabetes: A Prospective Group Match Study
- ClinicalTrials.gov ID
- NCT01044602
- Acronym / sponsor ID
- 2009H0282
- Conditions
- Obesity, Type 2 Diabetes Mellitus
- Keywords
- Obesity, Type 2 Diabetes Mellitus, Roux-en-Y Gastric Bypass Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- David Bradley MDUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- Jan 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 8 Jan 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.
Best medical management and gastric bypass surgery is a way to treat diabetes as part of regular medical care (standard of care). However, gastric bypass surgery is not a way to treat diabetes as part of regular medical care (standard of care).
Detailed description
Best medical management and gastric bypass surgery are ways to treat obesity as part of regular medical care (standard of care). Best medical management is a way to treat diabetes as part of regular medical care (standard of care). However, gastric bypass surgery is not a way to treat diabetes as part of regular medical care (standard of care). But, studies suggest that diabetes gets better or goes away after gastric bypass surgery. This study is being done to find out if diabetes gets better or goes away completely after a patient has gastric bypass surgery as part of regular medical care (standard of care).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best Medical Management | Active comparator | Other: Laboratory evaluations, sleep study, Other: Best Medical ManagementPatients elect to treat obesity and type 2 diabetes mellitus through best medical management. |
| Surgical Treatment | Active comparator | Other: Laboratory evaluations, sleep study, Procedure: Roux-en-Y gastric bypass surgeryPatients with type 2 diabetes mellitus choice to treat obesity with Roux-en-Y gastric bypass. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 25 to 70
- BMI 35 or greater
- HbA1c>6.5%
- Stable weight
- Stable medications
Key exclusion criteria (16 listed)
- Coagulopathy
- Liver cirrhosis
- C-peptide <1 ng/ml (off insulin)
- Diagnosis of severe eating disorder
- Untreated endocrine disorder
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 |
|---|---|---|
| Laboratory evaluations, sleep studyFasting plasma glucose, liver function tests, chem-7, HOMA-IR, HBA1C, lipid profile, indirect calorimetry. | Other | Best Medical Management, Surgical Treatment |
| Best Medical ManagementStandard of care. | Other | Best Medical Management |
| Roux-en-Y gastric bypass surgerySurgical treatment. | Procedure or surgery | Surgical Treatment |
Primary outcome
Resolution of type 2 diabetes mellitus, determined by oral glucose tolerance test.
Time frame: 2 years
Resolution of obesity co-morbidities including hypertension, OSA, and hyperlipidemia
Time frame: 2 years
3 secondary outcomes
Improvement in glucose control
Time frame: 2 years
Improvement in control of chronic co-morbidities
Time frame: 2 years
Identify predictors of success with regard to improved co-morbidities and velocity of weight loss
Time frame: 2 years
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 21 Apr 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.
Asem Ali, 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?
A study testing Laboratory evaluations, sleep study, Best Medical Management and Roux-en-Y gastric bypass surgery in people with Obesity and Type 2 Diabetes Mellitus, run by David Bradley MD 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 5 inclusion and 16 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 21 Apr 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?
Resolution of type 2 diabetes mellitus, determined by oral glucose tolerance test. (time frame: 2 years). The study lists 2 primary outcomes in all. 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 21 Apr 2015.