Laparoscopic Gastric Bypass for Type 2 Diabetes Mellitus With Body Mass Index (BMI) < 35

NCT ID: NCT00999050

Last Updated: 2011-01-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2013-11-30

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

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

diabetic pts <35BMI

All patients will be in a single arm receiving bypass surgery to assist with diabetes management

Group Type: EXPERIMENTAL

Gastric bypass for diabetic patients <35 BMI

Intervention Type: PROCEDURE

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.

Interventions

Gastric 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.

Intervention Type: PROCEDURE

Other Intervention Names

gastric bypass surgery

Eligibility Criteria

Inclusion Criteria

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

1. Enrollment in another clinical study, which involves an investigational drug

2. Diagnosis of type 1 Diabetes Mellitus or other genetic forms of Diabetes Mellitus

3. Significant renal failure of chronic liver disease (except NAFLD)

4. Major psychological disorders

5. 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

6. Previous gastric or esophageal surgery

7. Immunosuppressive drugs including corticosteroids

8. Coagulopathy defined as an INR > 1.5 or platelet count < 50,000/µl

9. Anemia defined as a Hb <10.0 g/dl

10. Inflammatory bowel diseases or other medical condition that would serve as a contraindication to gastric bypass (eg. celiac sprue, pancreatic insufficiency)

11. A severe concurrent illness that is likely to limit life or require extensive systemic treatment (e.g. cancer)

12. A pre-existing major complication of diabetes:

1. unstable, proliferative retinopathy

2. severe autonomic cardiac neuropathy or intestinal neuropathy

3. Myocardial infarction within the previous year, current unstable angina, or poorly-controlled congestive heart failure (Stage III)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Weill Medical College

Locations

Weill Cornell Medical College New York Prysbyterian Hosptial

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Maureen Morrison, MSN-ACNP, DNPc

Role: CONTACT

msm7003@med.cornell.edu

212-746-5925

Tina Chuck, MPH

Role: CONTACT

tic2005@med.cornell.edu

212-746-5725

Facility Contacts

Francisco Rubino, MD

Role: primary

frr2007@med.cornell.edu

212-746-5925

Gladys W Strain, PhD

Role: backup

gls2010@med.cornell.edu

212-746-5661

References

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.

Reference Type: BACKGROUND

Other Identifiers

0906010450

Identifier Type: -

Identifier Source: org_study_id