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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Gastric bypass for diabetic patients <35 BMI

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring type two diabetes, gastric bypass surgery, overweight or moderately obese

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:
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
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

Exclusion Criteria

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
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:
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)

Sites / Locations

Weill Cornell Medical College New York Prysbyterian HosptialRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

diabetic pts <35BMI

Arm Description

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

Outcomes

Primary Outcome Measures

Hemoglobin A1C changes

Secondary Outcome Measures

improvement in glycemic control

Full Information

NCT ID

NCT00999050

First Posted

October 14, 2009

Last Updated

January 3, 2011

Sponsor

Weill Medical College of Cornell University

1. Study Identification

Unique Protocol Identification Number

NCT00999050

Brief Title

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

Official Title

Laparoscopic Gastric Bypass for Type 2 Diabetes Mellitus: a Pilot Prospective Study in Overweight and Mildly Obese Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Unknown status

Study Start Date

October 2009 (undefined)

Primary Completion Date

October 2011 (Anticipated)

Study Completion Date

November 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

type two diabetes, gastric bypass surgery, overweight or moderately obese

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

diabetic pts <35BMI

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Gastric bypass for diabetic patients <35 BMI

Other Intervention Name(s)

gastric bypass surgery

Intervention Description

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.

Primary Outcome Measure Information:

Title

Hemoglobin A1C changes

Time Frame

Post gastric bypass operation

Secondary Outcome Measure Information:

Title

improvement in glycemic control

Time Frame

1 to two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 Exclusion Criteria 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 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maureen Morrison, MSN-ACNP, DNPc

Phone

212-746-5925

msm7003@med.cornell.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Tina Chuck, MPH

Phone

212-746-5725

tic2005@med.cornell.edu

Facility Information:

Facility Name

Weill Cornell Medical College New York Prysbyterian Hosptial

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Francisco Rubino, MD

Phone

212-746-5925

frr2007@med.cornell.edu

First Name & Middle Initial & Last Name & Degree

Gladys W Strain, PhD

Phone

212-746-5661

gls2010@med.cornell.edu

12. IPD Sharing Statement

Citations:

Citation

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.

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

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