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

July 18, 2017 updated by: The Cleveland Clinic

STAMPEDE: Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Medical therapy
Intensive medical therapy for diabetes
Active Comparator: Gastric Bypass
Procedure/Surgery: Bariatric surgery laparoscipic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
Procedure: Gastric bypass
Roux-en-Y gastric bypass
Other Names:
  • RYGB
Active Comparator: Sleeve Gastrectomy
Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
Procedure: Sleeve Gastrectomy
Laparoscopic sleeve gastrectomy
Other Names:
  • SG

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
1 year
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.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Specific Metabolic Parameters (Insulin Secretion and Resistance).
Time Frame: 1, 2, and 5 years
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
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.
1, 2, and 5 years.
Change in Glycated Hemoglobin (HbA1c)
Time Frame: 1 year - baseline
Change in glycated hemoglobin(HbA1c)from baseline in percentage points / percent change
1 year - baseline
Fasting Plasma Glucose
Time Frame: 1 year
Fasting Plasma Glucose measured in mg/dL.
1 year
Glycated Hemoglobin (HbA1c)
Time Frame: 1 year
Mean glycated hemoglobin (HbA1c) at 12 months for each of the 3 groups, in percentage points
1 year
Body Weight
Time Frame: 1 year
Body weight in kilograms (kg) measured at 12 months
1 year
Change in Body Weight From Baseline
Time Frame: 1 year
Mean change in body weight from baseline measured in kilograms (kg)
1 year
Body Mass Index (BMI)
Time Frame: 1 year
Body Mass Index (BMI) at 12 months measured as kg/m2
1 year
Change in Body Mass Index (BMI)
Time Frame: 1 year
Change in Body Mass Index (BMI) at 12 months, measured in kg/m2
1 year
Change in Systolic Blood Pressure (SBP)
Time Frame: 1 year
Change in Systolic Blood Pressure (SBP) at 12 months
1 year
Change in High-density Lipoprotein (HDL)
Time Frame: 1 year
Percent change in high-density lipoprotein (HDL) at 12 months
1 year
Change in Triglycerides
Time Frame: 1 year
Median percent change in triglycerides at 12 months from baseline measure
1 year
Change in High-sensitivity C-reactive Protein (Hs-CRP)
Time Frame: 1 year
Median percent change in high-sensitivity C-reactive protein (hs-CRP)from baseline at 12 months
1 year
Diabetes Medication - Use of Insulin
Time Frame: 1 year
Number of participants taking insulin at 12 months
1 year
Diabetes Medication - Use of Biguanides
Time Frame: 1 year
Number of participants taking Biguanides at 12 months
1 year
Diabetes Medication - Use of Thiazolidinedione
Time Frame: 1 year
Number of participants using thiazolidinedione at 12 months
1 year
Diabetes Medication - Use of Incretin Mimetics
Time Frame: 1 year
Number of participants taking Incretin Mimetics
1 year
Diabetes Medication - Use of Secretagogue
Time Frame: 1 year
Number of participants taking Secretagogues at 12 months
1 year
Cardiovascular Medications - Lipid Lowering Agents
Time Frame: 1 year
Number of participants taking Lipid lowering agents at 12 months
1 year
Cardiovascular Medications - Beta Blocker
Time Frame: 1 year
Number of participants taking Beta Blockers at 12 months
1 year
Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB)
Time Frame: 1 year
Number of participants taking Angiotensin-converting enzyme (ACE Inhibitor) or Angiotensin-receptor blocker (ARB) at 12 months
1 year
Cardiovascular Medications - Anticoagulants
Time Frame: 1 year
Number of participants taking anticoagulants at 12 months
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Cleveland Clinic

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ethicon Endo-Surgery
LifeScan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Philip R Schauer, MD, Director, Bariatric and Metabolic Institute, Cleveland Clinic Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EES IIS 19900

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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