Diabetes Mellitus, Type 2NCT00432809

Advanced Medical Therapy Versus Advanced Medical Therapy Plus Bariatric Surgery for the Resolution of Type 2 Diabetes

A study testing Gastric bypass and Sleeve Gastrectomy in people with Diabetes Mellitus, Type 2 and Obesity, run by The Cleveland Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The aim of the study is to compare the relative clinical outcomes between advanced medical therapy alone or advanced medical therapy combined with bariatric surgery [either Roux-en-Y gastric bypass (RYGBP) or laparoscopic sleeve gastrectomy] in patients with type 2 diabetes and a body mass index (BMI) between 27 and… Read more about this study

Who is it for?: Ages 20 to 60 years
Conditions the study is for: Diabetes Mellitus, Type 2, Obesity
What is being tested?: Gastric bypass and Sleeve Gastrectomy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 1 siteUnited States
Study dates: Feb 2007to Sep 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Type 2 diabetes mellitus with HbA1c > 7.0%
Body mass index > 27 and < 43 kg/m2
Candidate for general anesthesia

Who cannot join

Prior bariatric surgery of any kind
Cardiovascular conditions including significant coronary artery disease, peripheral vascular disease, uncompensated congestive heart failure, history of stroke, or uncontrolled hypertension
Kidney disease or chronic renal insufficiency with a creatinine level > 1.8 mg/dl
Known history of chronic liver disease (except for NAFLD/NASH)
Gastrointestinal disorders, malabsorptive disorders, or inflammatory bowel disease
Psychiatric disorders including dementia, active psychosis, severe depression requiring > 2 medications, history of suicide attempts, alcohol or drug abuse within the previous 12 months
Severe pulmonary disease defined as FEV1 < 50% of predicted value
Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic
Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: STAMPEDE: Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently

Conditions: Diabetes Mellitus, Type 2, Obesity
Being tested: Gastric bypass, Sleeve Gastrectomy
Keywords: Diabetes Mellitus, Type 2, Obesity
Medical subject headings: Diabetes Mellitus, Type 2, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Gastric bypassProcedure or surgery
Also called RYGB
Roux-en-Y gastric bypass
Sleeve GastrectomyProcedure or surgery
Also called SG
Laparoscopic sleeve gastrectomy

Study groups in NCT00432809
Study group	Role	What they receive
Medical therapy	No intervention	Intensive medical therapy for diabetes
Gastric Bypass	Active comparator	Procedure/Surgery: Bariatric surgery laparoscipic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy Receives: Procedure: Gastric bypass
Sleeve Gastrectomy	Active comparator	Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy Receives: Procedure: Sleeve Gastrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%.
The proportion of subjects with a glycated hemoglobin level of 6% or less(with or without diabetes medications) 12 months after randomization (baseline measure).
Measured: 1 year
Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications
The proportion of subjects with a glycated hemoglobin level of 6% or less(without diabetes medications) 12 months after randomization.
Measured: 1 year

Secondary outcomes (23)

Changes in Specific Metabolic Parameters (Insulin Secretion and Resistance).
Measured: 1, 2, and 5 years
Changes in Obesity-related Comorbidities (Blood Pressure, Dyslipidemia), Quality of Life, and Hospitalizations.
Measured: 1, 2, and 5 years
The Cost-effectiveness of Each Program and the Side Effects and /or Complications.
Measured: 1, 2, and 5 years.
Change in Glycated Hemoglobin (HbA1c)
Change in glycated hemoglobin(HbA1c)from baseline in percentage points / percent change
Measured: 1 year - baseline
Fasting Plasma Glucose
Fasting Plasma Glucose measured in mg/dL.
Measured: 1 year
Glycated Hemoglobin (HbA1c)
Mean glycated hemoglobin (HbA1c) at 12 months for each of the 3 groups, in percentage points
Measured: 1 year
Body Weight
Body weight in kilograms (kg) measured at 12 months
Measured: 1 year
Change in Body Weight From Baseline
Mean change in body weight from baseline measured in kilograms (kg)
Measured: 1 year
Body Mass Index (BMI)
Body Mass Index (BMI) at 12 months measured as kg/m2
Measured: 1 year
Change in Body Mass Index (BMI)
Change in Body Mass Index (BMI) at 12 months, measured in kg/m2
Measured: 1 year
Change in Systolic Blood Pressure (SBP)
Change in Systolic Blood Pressure (SBP) at 12 months
Measured: 1 year
Change in High-density Lipoprotein (HDL)
Percent change in high-density lipoprotein (HDL) at 12 months
Measured: 1 year
Change in Triglycerides
Median percent change in triglycerides at 12 months from baseline measure
Measured: 1 year
Change in High-sensitivity C-reactive Protein (Hs-CRP)
Median percent change in high-sensitivity C-reactive protein (hs-CRP)from baseline at 12 months
Measured: 1 year
Diabetes Medication - Use of Insulin
Number of participants taking insulin at 12 months
Measured: 1 year
Diabetes Medication - Use of Biguanides
Number of participants taking Biguanides at 12 months
Measured: 1 year
Diabetes Medication - Use of Thiazolidinedione
Number of participants using thiazolidinedione at 12 months
Measured: 1 year
Diabetes Medication - Use of Incretin Mimetics
Number of participants taking Incretin Mimetics
Measured: 1 year
Diabetes Medication - Use of Secretagogue
Number of participants taking Secretagogues at 12 months
Measured: 1 year
Cardiovascular Medications - Lipid Lowering Agents
Number of participants taking Lipid lowering agents at 12 months
Measured: 1 year
Cardiovascular Medications - Beta Blocker
Number of participants taking Beta Blockers at 12 months
Measured: 1 year
Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB)
Number of participants taking Angiotensin-converting enzyme (ACE Inhibitor) or Angiotensin-receptor blocker (ARB) at 12 months
Measured: 1 year
Cardiovascular Medications - Anticoagulants
Number of participants taking anticoagulants at 12 months
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2007Sep 2016

First posted8 Feb 2007 (estimated)
Study startFeb 2007
Primary completionFeb 2016
Study completionSep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by The Cleveland ClinicThe 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00432809
Sponsor's protocol ID: EES IIS 19900
Status last verified: Jul 2017
First submitted: 6 Feb 2007
Last updated: 23 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

O'Brien PE, Dixon JB, Laurie C, Skinner S, Proietto J, McNeil J, Strauss B, Marks S, Schachter L, Chapman L, Anderson M. Treatment of mild to moderate obesity with laparoscopic adjustable gastric banding or an intensive medical program: a randomized trial. Ann Intern Med. 2006 May 2;144(9):625-33. doi: 10.7326/0003-4819-144-9-200605020-00005.
PubMed 16670131
Schauer PR, Burguera B, Ikramuddin S, Cottam D, Gourash W, Hamad G, Eid GM, Mattar S, Ramanathan R, Barinas-Mitchel E, Rao RH, Kuller L, Kelley D. Effect of laparoscopic Roux-en Y gastric bypass on type 2 diabetes mellitus. Ann Surg. 2003 Oct;238(4):467-84; discussion 84-5. doi: 10.1097/01.sla.0000089851.41115.1b.
PubMed 14530719
Brethauer SA, Chand B, Schauer PR. Risks and benefits of bariatric surgery: current evidence. Cleve Clin J Med. 2006 Nov;73(11):993-1007. doi: 10.3949/ccjm.73.11.993.
PubMed 17128540
Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53.
PubMed 9742976
Harris MI, Flegal KM, Cowie CC, Eberhardt MS, Goldstein DE, Little RR, Wiedmeyer HM, Byrd-Holt DD. Prevalence of diabetes, impaired fasting glucose, and impaired glucose tolerance in U.S. adults. The Third National Health and Nutrition Examination Survey, 1988-1994. Diabetes Care. 1998 Apr;21(4):518-24. doi: 10.2337/diacare.21.4.518.
PubMed 9571335
Nathan DM. Clinical practice. Initial management of glycemia in type 2 diabetes mellitus. N Engl J Med. 2002 Oct 24;347(17):1342-9. doi: 10.1056/NEJMcp021106. No abstract available.
PubMed 12397193
The relationship of glycemic exposure (HbA1c) to the risk of development and progression of retinopathy in the diabetes control and complications trial. Diabetes. 1995 Aug;44(8):968-83.
PubMed 7622004
Hogan P, Dall T, Nikolov P; American Diabetes Association. Economic costs of diabetes in the US in 2002. Diabetes Care. 2003 Mar;26(3):917-32. doi: 10.2337/diacare.26.3.917.
PubMed 12610059
Schauer PR, Bhatt DL, Kirwan JP, Wolski K, Aminian A, Brethauer SA, Navaneethan SD, Singh RP, Pothier CE, Nissen SE, Kashyap SR; STAMPEDE Investigators. Bariatric Surgery versus Intensive Medical Therapy for Diabetes - 5-Year Outcomes. N Engl J Med. 2017 Feb 16;376(7):641-651. doi: 10.1056/NEJMoa1600869.
PubMed 28199805
Schauer PR, Bhatt DL, Kirwan JP, Wolski K, Brethauer SA, Navaneethan SD, Aminian A, Pothier CE, Kim ES, Nissen SE, Kashyap SR; STAMPEDE Investigators. Bariatric surgery versus intensive medical therapy for diabetes--3-year outcomes. N Engl J Med. 2014 May 22;370(21):2002-13. doi: 10.1056/NEJMoa1401329. Epub 2014 Mar 31.
PubMed 24679060
Kashyap SR, Bhatt DL, Wolski K, Watanabe RM, Abdul-Ghani M, Abood B, Pothier CE, Brethauer S, Nissen S, Gupta M, Kirwan JP, Schauer PR. Metabolic effects of bariatric surgery in patients with moderate obesity and type 2 diabetes: analysis of a randomized control trial comparing surgery with intensive medical treatment. Diabetes Care. 2013 Aug;36(8):2175-82. doi: 10.2337/dc12-1596. Epub 2013 Feb 25.
PubMed 23439632
Schauer PR, Kashyap SR, Wolski K, Brethauer SA, Kirwan JP, Pothier CE, Thomas S, Abood B, Nissen SE, Bhatt DL. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012 Apr 26;366(17):1567-76. doi: 10.1056/NEJMoa1200225. Epub 2012 Mar 26.
PubMed 22449319

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: STAMPEDE: Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently
ClinicalTrials.gov ID: NCT00432809
Acronym / sponsor ID: EES IIS 19900
Conditions: Diabetes Mellitus, Type 2, Obesity
Keywords: Diabetes Mellitus, Type 2, Obesity
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: The Cleveland ClinicUniversity, hospital or other
Collaborators: Ethicon Endo-Surgery, LifeScan
Study start: Feb 2007
Primary completion: Feb 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 8 Feb 2007 (estimated)
Results: Posted 11 Jun 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Medical therapy	No intervention	–Intensive medical therapy for diabetes
Gastric Bypass	Active comparator	Procedure: Gastric bypassProcedure/Surgery: Bariatric surgery laparoscipic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
Sleeve Gastrectomy	Active comparator	Procedure: Sleeve GastrectomyProcedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy

Who may qualify

Ages: 20 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Type 2 diabetes mellitus with HbA1c > 7.0%
Body mass index > 27 and < 43 kg/m2
Candidate for general anesthesia

Key exclusion criteria (8 listed)

Prior bariatric surgery of any kind
Cardiovascular conditions including significant coronary artery disease, peripheral vascular disease, uncompensated congestive heart failure, history of stroke, or uncontrolled hypertension
Kidney disease or chronic renal insufficiency with a creatinine level > 1.8 mg/dl
Known history of chronic liver disease (except for NAFLD/NASH)
Gastrointestinal disorders, malabsorptive disorders, or inflammatory bowel disease

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
Gastric bypassAlso: RYGBRoux-en-Y gastric bypass	Procedure or surgery	Gastric Bypass
Sleeve GastrectomyAlso: SGLaparoscopic sleeve gastrectomy	Procedure or surgery	Sleeve Gastrectomy

Primary outcome

Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%.
Time frame: 1 year
The proportion of subjects with a glycated hemoglobin level of 6% or less(with or without diabetes medications) 12 months after randomization (baseline measure).
Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications
Time frame: 1 year
The proportion of subjects with a glycated hemoglobin level of 6% or less(without diabetes medications) 12 months after randomization.

23 secondary outcomes

Changes in Specific Metabolic Parameters (Insulin Secretion and Resistance).
Time frame: 1, 2, and 5 years
Changes in Obesity-related Comorbidities (Blood Pressure, Dyslipidemia), Quality of Life, and Hospitalizations.
Time frame: 1, 2, and 5 years
The Cost-effectiveness of Each Program and the Side Effects and /or Complications.
Time frame: 1, 2, and 5 years.
Change in Glycated Hemoglobin (HbA1c)
Time frame: 1 year - baseline
Fasting Plasma Glucose
Time frame: 1 year
Glycated Hemoglobin (HbA1c)
Time frame: 1 year
Body Weight
Time frame: 1 year
Change in Body Weight From Baseline
Time frame: 1 year
Body Mass Index (BMI)
Time frame: 1 year
Change in Body Mass Index (BMI)
Time frame: 1 year
Change in Systolic Blood Pressure (SBP)
Time frame: 1 year
Change in High-density Lipoprotein (HDL)
Time frame: 1 year
Change in Triglycerides
Time frame: 1 year
Change in High-sensitivity C-reactive Protein (Hs-CRP)
Time frame: 1 year
Diabetes Medication - Use of Insulin
Time frame: 1 year
Diabetes Medication - Use of Biguanides
Time frame: 1 year
Diabetes Medication - Use of Thiazolidinedione
Time frame: 1 year
Diabetes Medication - Use of Incretin Mimetics
Time frame: 1 year
Diabetes Medication - Use of Secretagogue
Time frame: 1 year
Cardiovascular Medications - Lipid Lowering Agents
Time frame: 1 year
Cardiovascular Medications - Beta Blocker
Time frame: 1 year
Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB)
Time frame: 1 year
Cardiovascular Medications - Anticoagulants
Time frame: 1 year

Results and safety

Results posted to the registry on 11 Jun 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Medical Therapy	50	41
Gastric Bypass	50	50
Sleeve Gastrectomy	50	49

Primary outcome: Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%.

Time frame: 1 year. Number. Unit: participants

Measure	Medical Therapy n = 41	Gastric Bypass n = 50	Sleeve Gastrectomy n = 49
Value	5	21	18

Medical Therapy vs Gastric Bypass: p = 0.002, Chi-squared
Medical Therapy vs Sleeve Gastrectomy: p = 0.008, Chi-squared
Gastric Bypass vs Sleeve Gastrectomy: p = 0.59, Chi-squared

Population analysed: Modified intent-to-treat (ITT) population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.

Primary outcome: Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications

Time frame: 1 year. Number. Unit: participants

Measure	Medical Therapy n = 41	Gastric Bypass n = 50	Sleeve Gastrectomy n = 49
Value	0	21	13

Medical Therapy vs Gastric Bypass: p <0.001, Chi-squared
Medical Therapy vs Sleeve Gastrectomy: p <0.001, Chi-squared
Gastric Bypass vs Sleeve Gastrectomy: p = 0.10, Chi-squared

Population analysed: Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.

23 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Medical Therapy	4 of 43 (9.3%)	42 of 43 (97.7%)	Not reported
Gastric Bypass	16 of 50 (32%)	48 of 50 (96%)	Not reported
Sleeve Gastrectomy	7 of 49 (14.3%)	49 of 49 (100%)	Not reported

Limitations and caveats (from the sponsor): Important limitations in the primary endpoint and 1 year outcomes are the short duration of follow-up (12 months), the study occurred at a single-center and the open-label nature of the study (subjects were not blinded to treatment).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16670131O'Brien PE, Dixon JB, Laurie C, Skinner S, Proietto J, McNeil J, Strauss B, Marks S, Schachter L, Chapman L, Anderson M. Treatment of mild to moderate obesity with laparoscopic adjustable gastric banding or an intensive medical program: a randomized trial. Ann Intern Med. 2006 May 2;144(9):625-33. doi: 10.7326/0003-4819-144-9-200605020-00005.
Background: PubMed 14530719Schauer PR, Burguera B, Ikramuddin S, Cottam D, Gourash W, Hamad G, Eid GM, Mattar S, Ramanathan R, Barinas-Mitchel E, Rao RH, Kuller L, Kelley D. Effect of laparoscopic Roux-en Y gastric bypass on type 2 diabetes mellitus. Ann Surg. 2003 Oct;238(4):467-84; discussion 84-5. doi: 10.1097/01.sla.0000089851.41115.1b.
Background: PubMed 17128540Brethauer SA, Chand B, Schauer PR. Risks and benefits of bariatric surgery: current evidence. Cleve Clin J Med. 2006 Nov;73(11):993-1007. doi: 10.3949/ccjm.73.11.993.
Background: PubMed 9742976Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53.
Background: PubMed 9571335Harris MI, Flegal KM, Cowie CC, Eberhardt MS, Goldstein DE, Little RR, Wiedmeyer HM, Byrd-Holt DD. Prevalence of diabetes, impaired fasting glucose, and impaired glucose tolerance in U.S. adults. The Third National Health and Nutrition Examination Survey, 1988-1994. Diabetes Care. 1998 Apr;21(4):518-24. doi: 10.2337/diacare.21.4.518.
Background: PubMed 12397193Nathan DM. Clinical practice. Initial management of glycemia in type 2 diabetes mellitus. N Engl J Med. 2002 Oct 24;347(17):1342-9. doi: 10.1056/NEJMcp021106. No abstract available.
Background: PubMed 7622004The relationship of glycemic exposure (HbA1c) to the risk of development and progression of retinopathy in the diabetes control and complications trial. Diabetes. 1995 Aug;44(8):968-83.
Background: PubMed 12610059Hogan P, Dall T, Nikolov P; American Diabetes Association. Economic costs of diabetes in the US in 2002. Diabetes Care. 2003 Mar;26(3):917-32. doi: 10.2337/diacare.26.3.917.
Derived from this study: PubMed 28199805Schauer PR, Bhatt DL, Kirwan JP, Wolski K, Aminian A, Brethauer SA, Navaneethan SD, Singh RP, Pothier CE, Nissen SE, Kashyap SR; STAMPEDE Investigators. Bariatric Surgery versus Intensive Medical Therapy for Diabetes - 5-Year Outcomes. N Engl J Med. 2017 Feb 16;376(7):641-651. doi: 10.1056/NEJMoa1600869.
Derived from this study: PubMed 24679060Schauer PR, Bhatt DL, Kirwan JP, Wolski K, Brethauer SA, Navaneethan SD, Aminian A, Pothier CE, Kim ES, Nissen SE, Kashyap SR; STAMPEDE Investigators. Bariatric surgery versus intensive medical therapy for diabetes--3-year outcomes. N Engl J Med. 2014 May 22;370(21):2002-13. doi: 10.1056/NEJMoa1401329. Epub 2014 Mar 31.
Derived from this study: PubMed 23439632Kashyap SR, Bhatt DL, Wolski K, Watanabe RM, Abdul-Ghani M, Abood B, Pothier CE, Brethauer S, Nissen S, Gupta M, Kirwan JP, Schauer PR. Metabolic effects of bariatric surgery in patients with moderate obesity and type 2 diabetes: analysis of a randomized control trial comparing surgery with intensive medical treatment. Diabetes Care. 2013 Aug;36(8):2175-82. doi: 10.2337/dc12-1596. Epub 2013 Feb 25.
Derived from this study: PubMed 22449319Schauer PR, Kashyap SR, Wolski K, Brethauer SA, Kirwan JP, Pothier CE, Thomas S, Abood B, Nissen SE, Bhatt DL. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012 Apr 26;366(17):1567-76. doi: 10.1056/NEJMoa1200225. Epub 2012 Mar 26.

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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.

Philip R Schauer, MD principal investigator

Director, Bariatric and Metabolic Institute, Cleveland Clinic Foundation

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Gastric bypass and Sleeve Gastrectomy in people with Diabetes Mellitus, Type 2 and Obesity, run by The Cleveland Clinic 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 8 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 23 Aug 2017. 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?

Yes. Results are posted in the registry (first posted 11 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%. (time frame: 1 year). 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?

On the ClinicalTrials.gov record for NCT00432809, which also lists 12 linked publications.

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 23 Aug 2017.