Type 2 DiabetesNCT01231308
Roux-en-Y-Gastric Bypass vs. Lifestyle Modification and Medical Therapy in the Treatment of Type 2 Diabetes
A study testing Roux-en-Y-Gastric Bypass and Intensive lifestyle modification and Optimal medical Therapy in people with Type 2 Diabetes, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The study is aimed to compare: Laparoscopic Roux-en-Y-Gastric Bypass (RYGB) + optimal medical therapy versus Intensive lifestyle modification and optimal medical therapy in the treatment of type 2 diabetes in overweight-to-moderately obese patients (BMI: 28-34kg/m2; the lower BMI cut-off will be 26kg/m2 in patients of… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Roux-en-Y-Gastric Bypass and Intensive lifestyle modification and Optimal medical Therapy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Oct 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 2 diabetes by any of the following:
- A fasting plasma glucose > 126 mg/dl confirmed on repeated testing
- 2 hour plasma glucose > 200mg/dl during a 75 gram oral glucose tolerance test
- HbA1c >6.5%
- A normal or high C-peptide level (> 0.9 ng/ml) to exclude type 1 diabetes and insulin deficient type 2 diabetes
- Negative AntiGAD 65 Antibodies
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- Body mass index (BMI) between 28 and 35 kg/m2 ( > 27.6 kg/m2 and < 34.5 kg/m2 ) that reflect a condition of overweight to moderate obesity.
- In consideration of the evidence that the associations between BMI, percentage of body fat, and CV risk differ across populations, and that the proportion of Asian people with a high risk of type 2 diabetes and cardiovascular disease is substantial at BMI's lower than the existing WHO cut-off point for overweight (= 25 kg/m2) (source: WHO Expert consultation. Lancet. 2004 Jan 10;363(9403):157-63), the lower BMI cut-off for inclusion in this study will be 26kg/m2 for patients of Asian descent.
- No contraindications for surgery or General Anesthesia as determined by a multidisciplinary team (surgeon, endocrinologist/internist, cardiologist, nutritionist)
- . Between 21 and 65 years of age
- . Able to provide informed consent
- . If a female with reproductive potential, agreement to use a reliable method of birth control for 2 years following surgery (Barrier, birth control, patch).
- This precaution is necessary to prevent potential complications of pregnancy due to possible nutritional deficiencies in the period of more intense weight loss after surgery. On the other hand, this precaution will avoid erratic weight/glucose tolerance changes of pregnancy effecting results.
- Have valid health insurance
Who cannot join
- Diagnosis of diabetes more than 15 years (to exclude pts with significant decline in pancreatic function from long-standing diabetes)
- Insulin therapy for more than 12 years
- HbA1c higher than 10%
- Diagnosis of type 1 diabetes
- Enrolled in another clinical study which involves an investigational drug
- Major psychological disorders
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- Pregnancy (all female patients will have serum beta hCG) or planned pregnancy within two years of entry into the study or unwilling to use reliable contraceptive method
- Previous gastric or esophageal surgery
- Immunosuppressive drugs including corticosteroids
- Coagulopathy (INR > 1.5 or platelets < 50,000/μl)
- Anemia (Hb < 10.0 g/dl)
- Any contraindication to laparoscopic gastric bypass or medical diabetes therapy
- A severe concurrent illness likely to limit life (e.g. cancer) or requiring extensive systemic treatment (e.g. ulcerative colitis)
- A significant malabsorptive or gastrointestinal disorder (e.g. pancreatic insufficiency, Celiac sprue, or Crohn's disease)
- Significant proteinuria (> 250 mg/dl)
- Severe neuropathy or clinical diagnosis of gastropathy (early satiety, nausea, vomiting, constipation alternating with diarrhea)
- Myocardial infarction in the previous year, current angina or heart failure
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medical College
New York, New York, 10065
Melissa Marine, 212-746-5725, mem9065@med.cornell.edu
Francesco Rubino, MD
About this study
Official title: Roux-en-Y-Gastric Bypass (RYGB) Versus Lifestyle Modification Plus Medical Therapy in the Treatment of Type 2 Diabetes in Overweight-to-Moderately Obese Patients: A Randomized Clinical Trial
The study is aimed to compare: Laparoscopic Roux-en-Y-Gastric Bypass (RYGB) + optimal medical therapy versus Intensive lifestyle modification and optimal medical therapy in the treatment of type 2 diabetes in overweight-to-moderately obese patients (BMI: 28-34kg/m2; the lower BMI cut-off will be 26kg/m2 in patients of Asian descent).
This is a single center, prospective randomized study. The study at the Weill College Medical College Diabetes Surgery Center. This study is intended to be a pilot investigation whose results can inform clinicians and researchers for future larger or multi-site trials of diabetes surgery. This study will also be used for the definition of a "core" protocol for independent randomized clinical trials to be carried out at various centers participating in a multinational consortium.
- Conditions
- Type 2 Diabetes
- Being tested
- Roux-en-Y-Gastric Bypass, Intensive lifestyle modification and Optimal medical Therapy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y-Gastric BypassProcedure or surgery
Standard laparoscopic gastric bypass. Preoperative preparation will include antibiotic prophylaxis given less than 60 minutes prior to making the first incision. Under general anesthesia with endotracheal intubation, a laparoscopic gastric bypass will be performed in the usual fashion.
Intensive lifestyle modification and Optimal medical TherapyBehavioural
Very low calorie diet consisting of 5 feedings: 2 liquid meal replacements, 2 low-calorie snacks, and 1 small meal of known caloric content. After 10% weight loss is achieved, the subjects will received individualized nutrition sessions beginning bi-weekly but extending time intervals as the weight loss progresses.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle modification | Active comparator | Intensive nutritional/exercise counseling for weight loss by lifestyle modification in addition to optimum medical treatment. Receives: Behavioral: Intensive lifestyle modification and Optimal medical Therapy |
| Roux-en-Y-Gastric Bypass | Experimental | A laparoscopic gastric bypass will be performed in the treatment of type 2 diabetes in Overweight-to-Moderately Obese Patients Receives: Procedure: Roux-en-Y-Gastric Bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end-point will be the control of hyperglycemia (HbA1c <6.5% + FG<126mg/dl).
Measured: Monthly after initiation of study for a minimum of 3 months, and then every monthly until HbA1c is below 7%
Secondary outcomes (1)
Short (2 yrs) and long term (5 yrs.) achievement of 'adequate" glycemic control, mean change in HbA1c from baseline.
Measured: Year 2 and year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2013 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Sponsor
- Investigators
- Francesco Rubino, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231308
- Sponsor's protocol ID
- 1002010906
- Status last verified
- Dec 2012
- First submitted
- 27 Oct 2010
- Last updated
- 24 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Roux-en-Y-Gastric Bypass (RYGB) Versus Lifestyle Modification Plus Medical Therapy in the Treatment of Type 2 Diabetes in Overweight-to-Moderately Obese Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01231308
- Acronym / sponsor ID
- 1002010906
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- Oct 2010
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 1 Nov 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 study is aimed to compare: Laparoscopic Roux-en-Y-Gastric Bypass (RYGB) + optimal medical therapy versus Intensive lifestyle modification and optimal medical therapy in the treatment of type 2 diabetes in overweight-to-moderately obese patients (BMI: 28-34kg/m2; the lower BMI cut-off will be 26kg/m2 in patients of Asian descent).
This is a single center, prospective randomized study. The study at the Weill College Medical College Diabetes Surgery Center. This study is intended to be a pilot investigation whose results can inform clinicians and researchers for future larger or multi-site trials of diabetes surgery. This study will also be used for the definition of a "core" protocol for independent randomized clinical trials to be carried out at various centers participating in a multinational consortium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle modification | Active comparator | Behavioral: Intensive lifestyle modification and Optimal medical TherapyIntensive nutritional/exercise counseling for weight loss by lifestyle modification in addition to optimum medical treatment. |
| Roux-en-Y-Gastric Bypass | Experimental | Procedure: Roux-en-Y-Gastric BypassA laparoscopic gastric bypass will be performed in the treatment of type 2 diabetes in Overweight-to-Moderately Obese Patients |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Diagnosed with type 2 diabetes by any of the following:
- A normal or high C-peptide level (> 0.9 ng/ml) to exclude type 1 diabetes and insulin deficient type 2 diabetes
- Negative AntiGAD 65 Antibodies
- Body mass index (BMI) between 28 and 35 kg/m2 ( > 27.6 kg/m2 and < 34.5 kg/m2 ) that reflect a condition of overweight to moderate obesity.
- In consideration of the evidence that the associations between BMI, percentage of body fat, and CV risk differ across populations, and that the proportion of Asian people with a high risk of type 2 diabetes and cardiovascular disease is substantial at BMI's lower than the existing WHO cut-off point for overweight (= 25 kg/m2) (source: WHO Expert consultation. Lancet. 2004 Jan 10;363(9403):157-63), the lower BMI cut-off for inclusion in this study will be 26kg/m2 for patients of Asian descent.
Key exclusion criteria (17 listed)
- Diagnosis of diabetes more than 15 years (to exclude pts with significant decline in pancreatic function from long-standing diabetes)
- Insulin therapy for more than 12 years
- HbA1c higher than 10%
- Diagnosis of type 1 diabetes
- Enrolled in another clinical study which involves an investigational drug
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 |
|---|---|---|
| Roux-en-Y-Gastric BypassStandard laparoscopic gastric bypass. Preoperative preparation will include antibiotic prophylaxis given less than 60 minutes prior to making the first incision. Under general anesthesia with endotracheal intubation, a laparoscopic gastric bypass will be performed in the usual fashion. | Procedure or surgery | Roux-en-Y-Gastric Bypass |
| Intensive lifestyle modification and Optimal medical TherapyVery low calorie diet consisting of 5 feedings: 2 liquid meal replacements, 2 low-calorie snacks, and 1 small meal of known caloric content. After 10% weight loss is achieved, the subjects will received individualized nutrition sessions beginning bi-weekly but extending time intervals as the weight loss progresses. | Behavioural | Lifestyle modification |
Primary outcome
The primary end-point will be the control of hyperglycemia (HbA1c <6.5% + FG<126mg/dl).
Time frame: Monthly after initiation of study for a minimum of 3 months, and then every monthly until HbA1c is below 7%
1 secondary outcome
Short (2 yrs) and long term (5 yrs.) achievement of 'adequate" glycemic control, mean change in HbA1c from baseline.
Time frame: Year 2 and year 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2012.
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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.
Francesco Rubino, MD principal investigator
Weill Medical College of Cornell 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 Roux-en-Y-Gastric Bypass and Intensive lifestyle modification and Optimal medical Therapy in people with Type 2 Diabetes, run by Weill Medical College of Cornell University 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 14 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 24 Dec 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melissa Marine (212-746-5725, mem9065@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary end-point will be the control of hyperglycemia (HbA1c <6.5% + FG<126mg/dl). (time frame: Monthly after initiation of study for a minimum of 3 months, and then every monthly until HbA1c is below 7%). 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 24 Dec 2012.