Laparoscopic Gastric Bypass for Type 2 Diabetes Mellitus With Body Mass Index (BMI) < 35
1 other identifier
interventional
50
1 country
1
Brief 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, 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus-type-2
Started Oct 2009
Longer than P75 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 14, 2009
CompletedFirst Posted
Study publicly available on registry
October 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedJanuary 4, 2011
January 1, 2011
2 years
October 14, 2009
January 3, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin A1C changes
Post gastric bypass operation
Secondary Outcomes (1)
improvement in glycemic control
1 to two years
Study Arms (1)
diabetic pts <35BMI
EXPERIMENTALAll patients will be in a single arm receiving bypass surgery to assist with diabetes management
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Weill Cornell Medical College New York Prysbyterian Hosptial
New York, New York, 10065, United States
Related Publications (1)
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.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 14, 2009
First Posted
October 21, 2009
Study Start
October 1, 2009
Primary Completion
October 1, 2011
Study Completion
November 1, 2013
Last Updated
January 4, 2011
Record last verified: 2011-01