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

Primary Purpose

Diabetes Mellitus, Type 2, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gastric bypass
Sleeve Gastrectomy
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Type 2, Obesity

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Medical therapy

Gastric Bypass

Sleeve Gastrectomy

Arm Description

Intensive medical therapy for diabetes

Procedure/Surgery: Bariatric surgery laparoscipic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy

Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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

Full Information

First Posted
February 6, 2007
Last Updated
July 18, 2017
Sponsor
The Cleveland Clinic
Collaborators
Ethicon Endo-Surgery, LifeScan
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1. Study Identification

Unique Protocol Identification Number
NCT00432809
Brief Title
Advanced Medical Therapy Versus Advanced Medical Therapy Plus Bariatric Surgery for the Resolution of Type 2 Diabetes
Official Title
STAMPEDE: Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
Collaborators
Ethicon Endo-Surgery, LifeScan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 43 kg/m2. The study will examine the short and long term effects of each intervention on biochemical resolution of diabetes, diabetic complications, and end-organ damage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Obesity
Keywords
Diabetes Mellitus, Type 2, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medical therapy
Arm Type
No Intervention
Arm Description
Intensive medical therapy for diabetes
Arm Title
Gastric Bypass
Arm Type
Active Comparator
Arm Description
Procedure/Surgery: Bariatric surgery laparoscipic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
Arm Title
Sleeve Gastrectomy
Arm Type
Active Comparator
Arm Description
Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
Intervention Type
Procedure
Intervention Name(s)
Gastric bypass
Other Intervention Name(s)
RYGB
Intervention Description
Roux-en-Y gastric bypass
Intervention Type
Procedure
Intervention Name(s)
Sleeve Gastrectomy
Other Intervention Name(s)
SG
Intervention Description
Laparoscopic sleeve gastrectomy
Primary Outcome Measure Information:
Title
Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%.
Description
The proportion of subjects with a glycated hemoglobin level of 6% or less(with or without diabetes medications) 12 months after randomization (baseline measure).
Time Frame
1 year
Title
Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications
Description
The proportion of subjects with a glycated hemoglobin level of 6% or less(without diabetes medications) 12 months after randomization.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Changes in Specific Metabolic Parameters (Insulin Secretion and Resistance).
Time Frame
1, 2, and 5 years
Title
Changes in Obesity-related Comorbidities (Blood Pressure, Dyslipidemia), Quality of Life, and Hospitalizations.
Time Frame
1, 2, and 5 years
Title
The Cost-effectiveness of Each Program and the Side Effects and /or Complications.
Time Frame
1, 2, and 5 years.
Title
Change in Glycated Hemoglobin (HbA1c)
Description
Change in glycated hemoglobin(HbA1c)from baseline in percentage points / percent change
Time Frame
1 year - baseline
Title
Fasting Plasma Glucose
Description
Fasting Plasma Glucose measured in mg/dL.
Time Frame
1 year
Title
Glycated Hemoglobin (HbA1c)
Description
Mean glycated hemoglobin (HbA1c) at 12 months for each of the 3 groups, in percentage points
Time Frame
1 year
Title
Body Weight
Description
Body weight in kilograms (kg) measured at 12 months
Time Frame
1 year
Title
Change in Body Weight From Baseline
Description
Mean change in body weight from baseline measured in kilograms (kg)
Time Frame
1 year
Title
Body Mass Index (BMI)
Description
Body Mass Index (BMI) at 12 months measured as kg/m2
Time Frame
1 year
Title
Change in Body Mass Index (BMI)
Description
Change in Body Mass Index (BMI) at 12 months, measured in kg/m2
Time Frame
1 year
Title
Change in Systolic Blood Pressure (SBP)
Description
Change in Systolic Blood Pressure (SBP) at 12 months
Time Frame
1 year
Title
Change in High-density Lipoprotein (HDL)
Description
Percent change in high-density lipoprotein (HDL) at 12 months
Time Frame
1 year
Title
Change in Triglycerides
Description
Median percent change in triglycerides at 12 months from baseline measure
Time Frame
1 year
Title
Change in High-sensitivity C-reactive Protein (Hs-CRP)
Description
Median percent change in high-sensitivity C-reactive protein (hs-CRP)from baseline at 12 months
Time Frame
1 year
Title
Diabetes Medication - Use of Insulin
Description
Number of participants taking insulin at 12 months
Time Frame
1 year
Title
Diabetes Medication - Use of Biguanides
Description
Number of participants taking Biguanides at 12 months
Time Frame
1 year
Title
Diabetes Medication - Use of Thiazolidinedione
Description
Number of participants using thiazolidinedione at 12 months
Time Frame
1 year
Title
Diabetes Medication - Use of Incretin Mimetics
Description
Number of participants taking Incretin Mimetics
Time Frame
1 year
Title
Diabetes Medication - Use of Secretagogue
Description
Number of participants taking Secretagogues at 12 months
Time Frame
1 year
Title
Cardiovascular Medications - Lipid Lowering Agents
Description
Number of participants taking Lipid lowering agents at 12 months
Time Frame
1 year
Title
Cardiovascular Medications - Beta Blocker
Description
Number of participants taking Beta Blockers at 12 months
Time Frame
1 year
Title
Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB)
Description
Number of participants taking Angiotensin-converting enzyme (ACE Inhibitor) or Angiotensin-receptor blocker (ARB) at 12 months
Time Frame
1 year
Title
Cardiovascular Medications - Anticoagulants
Description
Number of participants taking anticoagulants at 12 months
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes mellitus with HbA1c > 7.0% Body mass index > 27 and < 43 kg/m2 Candidate for general anesthesia Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip R Schauer, MD
Organizational Affiliation
Director, Bariatric and Metabolic Institute, Cleveland Clinic Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16670131
Citation
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.
Results Reference
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PubMed Identifier
14530719
Citation
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.
Results Reference
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PubMed Identifier
17128540
Citation
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.
Results Reference
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PubMed Identifier
9742976
Citation
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. Erratum In: Lancet 1999 Aug 14;354(9178):602.
Results Reference
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Citation
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.
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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.
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PubMed Identifier
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Citation
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.
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Citation
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.
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PubMed Identifier
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Citation
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.
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Citation
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.
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Results Reference
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Advanced Medical Therapy Versus Advanced Medical Therapy Plus Bariatric Surgery for the Resolution of Type 2 Diabetes

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