Roux-en-Y-Gastric Bypass vs. Lifestyle Modification and Medical Therapy in the Treatment of Type 2 Diabetes

NCT01231308 | Unknown DMC

• 1 other identifier: 1002010906
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The primary end-point will be the control of hyperglycemia (HbA1c <6.5% + FG<126mg/dl).

  Monthly after initiation of study for a minimum of 3 months, and then every monthly until HbA1c is below 7%

Secondary Outcomes (1)

• Short (2 yrs) and long term (5 yrs.) achievement of 'adequate" glycemic control, mean change in HbA1c from baseline.

  Year 2 and year 5

Study Arms (2)

Lifestyle modification

ACTIVE COMPARATOR

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

Behavioral: Intensive lifestyle modification and Optimal medical Therapy

Roux-en-Y-Gastric Bypass

EXPERIMENTAL

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

Procedure: Roux-en-Y-Gastric Bypass

Interventions

Roux-en-Y-Gastric Bypass PROCEDURE

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.

Roux-en-Y-Gastric Bypass

Intensive lifestyle modification and Optimal medical Therapy BEHAVIORAL

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.

Lifestyle modification

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with type 2 diabetes by any of the following:
• A fasting plasma glucose \> 126 mg/dl confirmed on repeated testing
• hour plasma glucose \> 200mg/dl during a 75 gram oral glucose tolerance test
• HbA1c \>6.5%
• A normal or high C-peptide level (\> 0.9 ng/ml) to exclude type 1 diabetes and insulin deficient type 2 diabetes
• Negative AntiGAD 65 Antibodies
• 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.
• No contraindications for surgery or General Anesthesia as determined by a multidisciplinary team (surgeon, endocrinologist/internist, cardiologist, nutritionist)
• Between 21 and 65 years of age
• Able to provide informed consent
• 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.
• Have valid health insurance

You may not qualify if:

• Diagnosis of diabetes more than 15 years (to exclude pts with significant decline in pancreatic function from long-standing diabetes)
• Insulin therapy for more than 12 years
• HbA1c higher than 10%
• Diagnosis of type 1 diabetes
• Enrolled in another clinical study which involves an investigational drug
• Major psychological disorders
• 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
• Previous gastric or esophageal surgery
• Immunosuppressive drugs including corticosteroids
• Coagulopathy (INR \> 1.5 or platelets \< 50,000/μl)
• Anemia (Hb \< 10.0 g/dl)
• Any contraindication to laparoscopic gastric bypass or medical diabetes therapy
• A severe concurrent illness likely to limit life (e.g. cancer) or requiring extensive systemic treatment (e.g. ulcerative colitis)
• A significant malabsorptive or gastrointestinal disorder (e.g. pancreatic insufficiency, Celiac sprue, or Crohn's disease)
• Significant proteinuria (\> 250 mg/dl)

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Medtronic - MITG: collaborator

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Francesco Rubino, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Marine

CONTACT

212-746-5725; mem9065@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2010
• First Posted: November 1, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2014
• Last Updated: December 24, 2012

Record last verified: 2012-12

Locations

US (1)