Advanced Medical Therapy Versus Advanced Medical Therapy Plus Bariatric Surgery for the Resolution of Type 2 Diabetes

NeuroTherapia, Inc.

Status: Completed

Conditions: Obesity; Diabetes Mellitus, Type 2

Treatments: Procedure: Sleeve Gastrectomy; Procedure: Gastric bypass

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00432809

EES IIS 19900

Details and patient eligibility

About

The aim of the study is to compare the relative clinical outcomes between advanced medical therapy alone or advanced medical therapy combined with bariatric surgery [either Roux-en-Y gastric bypass (RYGBP) or laparoscopic sleeve gastrectomy] in patients with type 2 diabetes and a body mass index (BMI) between 27 and 43 kg/m2. The study will examine the short and long term effects of each intervention on biochemical resolution of diabetes, diabetic complications, and end-organ damage.

Enrollment: 150 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus with HbA1c > 7.0%
• Body mass index > 27 and < 43 kg/m2
• Candidate for general anesthesia

Exclusion criteria

• Prior bariatric surgery of any kind
• Cardiovascular conditions including significant coronary artery disease, peripheral vascular disease, uncompensated congestive heart failure, history of stroke, or uncontrolled hypertension
• Kidney disease or chronic renal insufficiency with a creatinine level > 1.8 mg/dl
• Known history of chronic liver disease (except for NAFLD/NASH)
• Gastrointestinal disorders, malabsorptive disorders, or inflammatory bowel disease
• Psychiatric disorders including dementia, active psychosis, severe depression requiring > 2 medications, history of suicide attempts, alcohol or drug abuse within the previous 12 months
• Severe pulmonary disease defined as FEV1 < 50% of predicted value
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Medical therapy

No Intervention group

Description:

Intensive medical therapy for diabetes

Gastric Bypass

Active Comparator group

Description:

Procedure/Surgery: Bariatric surgery laparoscipic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy

Treatment:

Procedure: Gastric bypass

Sleeve Gastrectomy

Active Comparator group

Description:

Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy

Treatment:

Procedure: Sleeve Gastrectomy