Recruiting

Roux-en-Y-Gastric Bypass vs. Lifestyle Modification

Sponsor:

Weill Medical College of Cornell University

Code:

NCT01231308

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Interventions

Roux-en-Y-Gastric Bypass

Intensive lifestyle modification and Optimal medical Therapy

Study Details

Brief summary:

The study is aimed to compare: Laparoscopic Roux-en-Y-Gastric Bypass (RYGB) + optimal medical therapy versus Intensive lifestyle modification and optimal medical therapy in the treatment of type 2 diabetes in overweight-to-moderately obese patients (BMI: 28-34kg/m2; the lower BMI cut-off will be 26kg/m2 in patients of Asian descent).

This is a single center, prospective randomized study. The study at the Weill College Medical College Diabetes Surgery Center. This study is intended to be a pilot investigation whose results can inform clinicians and researchers for future larger or multi-site trials of diabetes surgery. This study will also be used for the definition of a "core" protocol for independent randomized clinical trials to be carried out at various centers participating in a multinational consortium.

Conditions

Type 2 Diabetes

Study ID

NCT01231308

Start date

Oct, 2010

Status verified date

Dec, 2012

Completion date

Oct, 2014

Anticipated

Primary completion date

Oct, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Diagnosed with type 2 diabetes by any of the following:

  • A fasting plasma glucose > 126 mg/dl confirmed on repeated testing
  • 2 hour plasma glucose > 200mg/dl during a 75 gram oral glucose tolerance test
  • HbA1c >6.5%
2. A normal or high C-peptide level (> 0.9 ng/ml) to exclude type 1 diabetes and insulin deficient type 2 diabetes
3. Negative AntiGAD 65 Antibodies
4. Body mass index (BMI) between 28 and 35 kg/m2 ( > 27.6 kg/m2 and < 34.5 kg/m2 ) that reflect a condition of overweight to moderate obesity.

In consideration of the evidence that the associations between BMI, percentage of body fat, and CV risk differ across populations, and that the proportion of Asian people with a high risk of type 2 diabetes and cardiovascular disease is substantial at BMI's lower than the existing WHO cut-off point for overweight (= 25 kg/m2) (source: WHO Expert consultation. Lancet. 2004 Jan 10;363(9403):157-63), the lower BMI cut-off for inclusion in this study will be 26kg/m2 for patients of Asian descent.
5. No contraindications for surgery or General Anesthesia as determined by a multidisciplinary team (surgeon, endocrinologist/internist, cardiologist, nutritionist)
6. . Between 21 and 65 years of age
7. . Able to provide informed consent
8. . If a female with reproductive potential, agreement to use a reliable method of birth control for 2 years following surgery (Barrier, birth control, patch).

This precaution is necessary to prevent potential complications of pregnancy due to possible nutritional deficiencies in the period of more intense weight loss after surgery. On the other hand, this precaution will avoid erratic weight/glucose tolerance changes of pregnancy effecting results.
9. Have valid health insurance

Exclusion Criteria:

1. Diagnosis of diabetes more than 15 years (to exclude pts with significant decline in pancreatic function from long-standing diabetes)
2. Insulin therapy for more than 12 years
3. HbA1c higher than 10%
4. Diagnosis of type 1 diabetes
5. Enrolled in another clinical study which involves an investigational drug
6. Major psychological disorders
7. Pregnancy (all female patients will have serum beta hCG) or planned pregnancy within two years of entry into the study or unwilling to use reliable contraceptive method
8. Previous gastric or esophageal surgery
9. Immunosuppressive drugs including corticosteroids
10. Coagulopathy (INR > 1.5 or platelets < 50,000/μl)
11. Anemia (Hb < 10.0 g/dl)
12. Any contraindication to laparoscopic gastric bypass or medical diabetes therapy
13. A severe concurrent illness likely to limit life (e.g. cancer) or requiring extensive systemic treatment (e.g. ulcerative colitis)
14. A significant malabsorptive or gastrointestinal disorder (e.g. pancreatic insufficiency, Celiac sprue, or Crohn's disease)
15. Significant proteinuria (> 250 mg/dl)
16. Severe neuropathy or clinical diagnosis of gastropathy (early satiety, nausea, vomiting, constipation alternating with diarrhea)
17. Myocardial infarction in the previous year, current angina or heart failure

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Lifestyle modification

Intensive nutritional/exercise counseling for weight loss by lifestyle modification in addition to optimum medical treatment.

experimental: Roux-en-Y-Gastric Bypass

A laparoscopic gastric bypass will be performed in the treatment of type 2 diabetes in Overweight-to-Moderately Obese Patients

Interventions

Roux-en-Y-Gastric Bypass

Standard laparoscopic gastric bypass. Preoperative preparation will include antibiotic prophylaxis given less than 60 minutes prior to making the first incision. Under general anesthesia with endotracheal intubation, a laparoscopic gastric bypass will be performed in the usual fashion.

Intensive lifestyle modification and Optimal medical Therapy

Very low calorie diet consisting of 5 feedings: 2 liquid meal replacements, 2 low-calorie snacks, and 1 small meal of known caloric content. After 10% weight loss is achieved, the subjects will received individualized nutrition sessions beginning bi-weekly but extending time intervals as the weight loss progresses.

Primary outcome measure

  • The primary end-point will be the control of hyperglycemia (HbA1c <6.5% + FG<126mg/dl). [ Time Frame: Monthly after initiation of study for a minimum of 3 months, and then every monthly until HbA1c is below 7% ]

Central Contacts and Locations

Central contacts

Locations

Weill Cornell Medical College

Recruiting

New York, New York, United States, 10065

Contacts

Principal Investigator:

Francesco Rubino, MD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Dec 24, 2012

Last verified

Dec, 2012

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2012-12-24.