Diabetes Mellitus, Type 2NCT00999050
Laparoscopic Gastric Bypass for Type 2 Diabetes Mellitus With Body Mass Index (BMI) < 35
A study testing Gastric bypass for diabetic patients <35 BMI in people with Diabetes Mellitus, Type 2, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The aim of this study is to evaluate the effect of Roux-en-y gastric bypass (RYGB) in controlling diabetes in subjects with mild obesity (BMI 26-35). The primary endpoint will be the reduction of HbA1c (< 7%), a standard measure of diabetes control; the secondary endpoints will be changes blood sugar , vitamin levels… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Gastric bypass for diabetic patients <35 BMI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Nov 2013
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males and females who meet the following inclusion criteria will be offered the opportunity to participate in the study:
- Diagnosis of type 2 Diabetes Mellitus (T2DM) confirmed by the following criteria:
- normal or high C-peptide level (> 0.9 ng/ml) to exclude type 1 Diabetes Mellitus
- positive glucagon test to confirm T2DM
- fasting plasma glucose of 126 mg/dl or more on at least two occasions
- Body mass index (BMI) 26 kg/m2 or greater, and less than 35 kg/m2
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- History of T2DM for not longer than 8 years, as long-standing disease beyond 8 years correlates with failure to achieve diabetes resolution after gastric bypass
- No contraindication for surgery or general anesthesia as determined by a multidisciplinary bariatric surgery team (surgeon, anesthesiologist, internist, dietitian, psychologist)
- Between 18 and 65 year of age
- Able to provide informed consent
- If a female with reproductive potential, she has to agree to use a reliable method of birth control for at least one year from the date of surgery
Who cannot join
- Subjects who meet any of the following exclusion criteria will not be eligible to participate in the study:
- Enrollment in another clinical study, which involves an investigational drug
- Diagnosis of type 1 Diabetes Mellitus or other genetic forms of Diabetes Mellitus
- Significant renal failure of chronic liver disease (except NAFLD)
- Major psychological disorders
- Pregnancy - all female subjects will have serum beta-hCG prior to operation, and must use birth control of their choice to avoid pregnancy during the first year after surgery
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- Previous gastric or esophageal surgery
- Immunosuppressive drugs including corticosteroids
- Coagulopathy defined as an INR > 1.5 or platelet count < 50,000/µl
- Anemia defined as a Hb <10.0 g/dl
- Inflammatory bowel diseases or other medical condition that would serve as a contraindication to gastric bypass (eg. celiac sprue, pancreatic insufficiency)
- A severe concurrent illness that is likely to limit life or require extensive systemic treatment (e.g. cancer)
- A pre-existing major complication of diabetes:
- unstable, proliferative retinopathy
- severe autonomic cardiac neuropathy or intestinal neuropathy
- Myocardial infarction within the previous year, current unstable angina, or poorly-controlled congestive heart failure (Stage III)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medical College New York Prysbyterian Hosptial
New York, New York, 10065
Francisco Rubino, MD, 212-746-5925, frr2007@med.cornell.edu
Gladys W Strain, PhD, 212-746-5661, gls2010@med.cornell.edu
About this study
Official title: Laparoscopic Gastric Bypass for Type 2 Diabetes Mellitus: a Pilot Prospective Study in Overweight and Mildly Obese Subjects
The aim of this study is to evaluate the effect of Roux-en-y gastric bypass (RYGB) in controlling diabetes in subjects with mild obesity (BMI 26-35). The primary endpoint will be the reduction of HbA1c (< 7%), a standard measure of diabetes control; the secondary endpoints will be changes blood sugar , vitamin levels, insulin, c-peptide, and lipids levels, as well as retinal eye examinations, urinalysis to assess kidney function, carotid ultrasound as a marker of cardiovascular function, and alterations in diabetic medications. Fifty subjects with medically documented type 2 Diabetes Mellitus (T2DM) with BMIs between 26 and 35 will undergo standard laparoscopic RYGB. Prior and after surgery, the subjects will undergo a clinical evaluation in regard to the primary and secondary endpoints listed. The pre-surgery evaluation is directed toward establishing the existence of diabetes related complications prior to surgery. After surgery subjects will be closely monitored for complications and required changes in their diabetes management. Repeat assessments will be made at 1, 3, 6, and 12 months and at two years.
Read the detailed description
The primary endpoint will be the reduction of HbA1c and secondary endpoints will be multiple associated parameters as listed below. A group of 50 subjects with medically documented T2DM and BMI of 26-35 will undergo standard laparoscopic RYGB. Prior to surgery, the subjects will undergo the standard pre-operative work up required for conventional bariatric surgery. This includes full history and physical exam, medical/cardiac clearances as needed, nutrition consultation and a gastrointestinal consultation for upper endoscopy. After thorough explanation an approved informed consent will be signed. Baseline parameters, as listed below, will be measured for each subject to identify possible complications of diabetes prior to the surgical intervention..
After surgery perioperative complications will be monitored and required modifications of diabetes management advised. Followed up measurements at 1, 3, 6, 12, and 24 months is consistent with standard clinical practice guidelines. Data analysis will be ongoing to observe the effects of the surgical intervention on glucose homeostasis.
- Baseline parameters
- History and Physical Exam
- Weight/BMI/ body composition with the Tanita 310.
- Waist Circumference
- Blood Pressure
- CBC
- HbA1c
- Fasting glucose
- Vitamin B6, B12, Folate,and Iron status
- Lipid Profile -total cholesterol, HDL, LDL, triglyceride
- Fasting Insulin and C-peptide
- Stimulated C-peptide
- EKG
- Retinal exam
- Urinalysis (assess for proteinuria and microalbuminuria)
- Comprehensive foot exam
- Medications and dosage
- Quality of Life Score (SF-36)
- Carotid ultrasound (intima-media thickness)
Follow-up:
4 Weeks:
- Physical Examination, wound check, Body weight, BMI,
- Glucose Diary (pre and postprandial glucose levels as required)
- Insulin and C-peptide
- Lipid profile
- Medication use 3 Months, 6 months,
Same as above plus:
- HbA1c
- Vitamin levels and iron status
- Retinal exam
- Annually the baseline measurements will be repeated
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Gastric bypass for diabetic patients <35 BMI
- Keywords
- type two diabetes, gastric bypass surgery, overweight or moderately obese
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric bypass for diabetic patients <35 BMIProcedure or surgery
Also called gastric bypass surgery
The operation is performed under general anesthesia. It is done laparoscopically, meaning that several small openings are made in the abdomen for insertion of long, thin surgical instruments, one with an attached camera. The operation is video monitored. The top of the stomach is divided across, leaving a small pouch for food. The rest of the stomach remains but can receive no food. The gut is divided just past the stomach, and it is attached to the small stomach pouch so that food can get back into the bowel. A second connection is made so that the bile and digestive juices pass into the bowel with the food.
| Study group | Role | What they receive |
|---|---|---|
| diabetic pts <35BMI | Experimental | All patients will be in a single arm receiving bypass surgery to assist with diabetes management Receives: Procedure: Gastric bypass for diabetic patients <35 BMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1C changes
Measured: Post gastric bypass operation
Secondary outcomes (1)
improvement in glycemic control
Measured: 1 to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2011 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 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
- Non-randomised
- Intervention model
- Single group
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999050
- Sponsor's protocol ID
- 0906010450
- Status last verified
- Jan 2011
- First submitted
- 14 Oct 2009
- Last updated
- 4 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cohen R, Pinheiro JS, Correa JL, Schiavon CA. Laparoscopic Roux-en-Y gastric bypass for BMI < 35 kg/m(2): a tailored approach. Surg Obes Relat Dis. 2006; 2(3):401-4. Cohen RV, Schiavon CA, Pinheiro JS, Correa JL, Rubino F. Duodenal-jejunal bypass for the treatment of type 2 diabetes in patients with body mass index of 22-34 kg/m2: a report of 2 cases. Surg Obes Relat Dis. 2007; 3(2): 195-7. Lee WJ, Wang W, Lee YC, Huang MT, Ser KH, Chen JC. Effect of laparoscopic mini-gastric bypass for type 2 diabetes mellitus: comparison of BMI>35 and <35 kg/m2. J Gastrointest Surg. 2008; 12(5): 945-52. Scopinaro N, Papadia F, Marinari G, Camerini G, Adami G. Long-term control of type 2 diabetes mellitus and the other major components of the metabolic syndrome after biliopancreatic diversion in patients with BMI < 35 kg/m2. Obes Surg. 2007; 17(2): 185-92. Chiellini C, Rubino F, Castagneto M, Nanni G, Mingrone G. The effect of bilio-pancreatic diversion on type 2 diabetes in patients with BMI <35 kg/m2. Diabetologia. 2009; 52(6): 1027-30.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Gastric Bypass for Type 2 Diabetes Mellitus: a Pilot Prospective Study in Overweight and Mildly Obese Subjects
- ClinicalTrials.gov ID
- NCT00999050
- Acronym / sponsor ID
- 0906010450
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- type two diabetes, gastric bypass surgery, overweight or moderately obese
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 21 Oct 2009 (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 aim of this study is to evaluate the effect of Roux-en-y gastric bypass (RYGB) in controlling diabetes in subjects with mild obesity (BMI 26-35). The primary endpoint will be the reduction of HbA1c (< 7%), a standard measure of diabetes control; the secondary endpoints will be changes blood sugar , vitamin levels, insulin, c-peptide, and lipids levels, as well as retinal eye examinations, urinalysis to assess kidney function, carotid ultrasound as a marker of cardiovascular function, and alterations in diabetic medications. Fifty subjects with medically documented type 2 Diabetes Mellitus (T2DM) with BMIs between 26 and 35 will undergo standard laparoscopic RYGB. Prior and after surgery, the subjects will undergo a clinical evaluation in regard to the primary and secondary endpoints listed. The pre-surgery evaluation is directed toward establishing the existence of diabetes related complications prior to surgery. After surgery subjects will be closely monitored for complications and required changes in their diabetes management. Repeat assessments will be made at 1, 3, 6, and 12 months and at two years.
Detailed description
The primary endpoint will be the reduction of HbA1c and secondary endpoints will be multiple associated parameters as listed below. A group of 50 subjects with medically documented T2DM and BMI of 26-35 will undergo standard laparoscopic RYGB. Prior to surgery, the subjects will undergo the standard pre-operative work up required for conventional bariatric surgery. This includes full history and physical exam, medical/cardiac clearances as needed, nutrition consultation and a gastrointestinal consultation for upper endoscopy. After thorough explanation an approved informed consent will be signed. Baseline parameters, as listed below, will be measured for each subject to identify possible complications of diabetes prior to the surgical intervention..
After surgery perioperative complications will be monitored and required modifications of diabetes management advised. Followed up measurements at 1, 3, 6, 12, and 24 months is consistent with standard clinical practice guidelines. Data analysis will be ongoing to observe the effects of the surgical intervention on glucose homeostasis.
- Baseline parameters
- History and Physical Exam
- Weight/BMI/ body composition with the Tanita 310.
- Waist Circumference
- Blood Pressure
- CBC
- HbA1c
- Fasting glucose
- Vitamin B6, B12, Folate,and Iron status
- Lipid Profile -total cholesterol, HDL, LDL, triglyceride
- Fasting Insulin and C-peptide
- Stimulated C-peptide
- EKG
- Retinal exam
- Urinalysis (assess for proteinuria and microalbuminuria)
- Comprehensive foot exam
- Medications and dosage
- Quality of Life Score (SF-36)
- Carotid ultrasound (intima-media thickness)
Follow-up:
4 Weeks:
- Physical Examination, wound check, Body weight, BMI,
- Glucose Diary (pre and postprandial glucose levels as required)
- Insulin and C-peptide
- Lipid profile
- Medication use 3 Months, 6 months,
Same as above plus:
- HbA1c
- Vitamin levels and iron status
- Retinal exam
- Annually the baseline measurements will be repeated
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diabetic pts <35BMI | Experimental | Procedure: Gastric bypass for diabetic patients <35 BMIAll patients will be in a single arm receiving bypass surgery to assist with diabetes management |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adult males and females who meet the following inclusion criteria will be offered the opportunity to participate in the study:
- Diagnosis of type 2 Diabetes Mellitus (T2DM) confirmed by the following criteria:
- Body mass index (BMI) 26 kg/m2 or greater, and less than 35 kg/m2
- History of T2DM for not longer than 8 years, as long-standing disease beyond 8 years correlates with failure to achieve diabetes resolution after gastric bypass
- No contraindication for surgery or general anesthesia as determined by a multidisciplinary bariatric surgery team (surgeon, anesthesiologist, internist, dietitian, psychologist)
Key exclusion criteria (16 listed)
- Subjects who meet any of the following exclusion criteria will not be eligible to participate in the study:
- Enrollment in another clinical study, which involves an investigational drug
- Diagnosis of type 1 Diabetes Mellitus or other genetic forms of Diabetes Mellitus
- Significant renal failure of chronic liver disease (except NAFLD)
- Major psychological disorders
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 bypass for diabetic patients <35 BMIAlso: gastric bypass surgeryThe operation is performed under general anesthesia. It is done laparoscopically, meaning that several small openings are made in the abdomen for insertion of long, thin surgical instruments, one with an attached camera. The operation is video monitored. The top of the stomach is divided across, leaving a small pouch for food. The rest of the stomach remains but can receive no food. The gut is divided just past the stomach, and it is attached to the small stomach pouch so that food can get back into the bowel. A second connection is made so that the bile and digestive juices pass into the bowel with the food. | Procedure or surgery | diabetic pts <35BMI |
Primary outcome
Hemoglobin A1C changes
Time frame: Post gastric bypass operation
1 secondary outcome
improvement in glycemic control
Time frame: 1 to two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2011.
- BackgroundCohen R, Pinheiro JS, Correa JL, Schiavon CA. Laparoscopic Roux-en-Y gastric bypass for BMI < 35 kg/m(2): a tailored approach. Surg Obes Relat Dis. 2006; 2(3):401-4. Cohen RV, Schiavon CA, Pinheiro JS, Correa JL, Rubino F. Duodenal-jejunal bypass for the treatment of type 2 diabetes in patients with body mass index of 22-34 kg/m2: a report of 2 cases. Surg Obes Relat Dis. 2007; 3(2): 195-7. Lee WJ, Wang W, Lee YC, Huang MT, Ser KH, Chen JC. Effect of laparoscopic mini-gastric bypass for type 2 diabetes mellitus: comparison of BMI>35 and <35 kg/m2. J Gastrointest Surg. 2008; 12(5): 945-52. Scopinaro N, Papadia F, Marinari G, Camerini G, Adami G. Long-term control of type 2 diabetes mellitus and the other major components of the metabolic syndrome after biliopancreatic diversion in patients with BMI < 35 kg/m2. Obes Surg. 2007; 17(2): 185-92. Chiellini C, Rubino F, Castagneto M, Nanni G, Mingrone G. The effect of bilio-pancreatic diversion on type 2 diabetes in patients with BMI <35 kg/m2. Diabetologia. 2009; 52(6): 1027-30.
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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.
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 for diabetic patients <35 BMI in people with Diabetes Mellitus, Type 2, 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 11 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: status not confirmed, as of the sponsor's last update on 4 Jan 2011. 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 Maureen Morrison, MSN-ACNP, DNPc (212-746-5925, msm7003@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1C changes (time frame: Post gastric bypass operation). 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 NCT00999050, which also lists 1 linked publication.
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 4 Jan 2011.