Diabetes Mellitus, Type 2
Conditions
Keywords
type two diabetes, gastric bypass surgery, overweight or moderately obese
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.
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
Interventions
PROCEDUREGastric bypass for diabetic patients <35 BMI
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.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Adult males and females who meet the following inclusion criteria will be offered the opportunity to participate in the study: 1. Diagnosis of type 2 Diabetes Mellitus (T2DM) confirmed by the following criteria: 1. normal or high C-peptide level (\> 0.9 ng/ml) to exclude type 1 Diabetes Mellitus 2. positive glucagon test to confirm T2DM 3. fasting plasma glucose of 126 mg/dl or more on at least two occasions 2. Body mass index (BMI) 26 kg/m2 or greater, and less than 35 kg/m2 3. 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 4. No contraindication for surgery or general anesthesia as determined by a multidisciplinary bariatric surgery team (surgeon, anesthesiologist, internist, dietitian, psychologist) 5. Between 18 and 65 year of age 6. Able to provide informed consent 7. 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
Exclusion criteria
Subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin A1C changes | Post gastric bypass operation |
Secondary
| Measure | Time frame |
|---|---|
| improvement in glycemic control | 1 to two years |
Countries
United States
Contacts
Primary ContactMaureen Morrison, MSN-ACNP, DNPc
Backup ContactTina Chuck, MPH
Outcome results
None listed