NCT02036138

The Efficacy of Bariatric Surgery Compared to Medical Therapy in Controlling Type2 Diabetes Mellitus in Patients With Non Morbid Obesity.

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The growing incidence of obesity and type2 DM globally is widely recognized as one of the most challenging contemporary threats to public health. Uncontrolled diabetes leads to macrovascular and microvascular complications, including myocardial infarction, stroke, blindness, neuropathy, and renal failure in many patients. The current goal of medical treatment is to halt disease progression by reducing hyperglycemia, hypertension, dyslipidemia, and other cardiovascular risk factors. Despite improvements in pharmacotherapy, fewer than 50% of patients with moderate-to-severe type 2 diabetes actually achieve and maintain therapeutic thresholds, particularly for glycemic control. Observational studies have suggested that bariatric or metabolic surgery can rapidly improve glycemic control and cardiovascular risk factors in severely obese patients with type 2 diabetes Few randomized, controlled trials have compared bariatric surgery with intensive medical therapy, particularly in moderately obese patients (defined as those having a BMI of 30 to 34.9) with type2 DM. Accordingly, many unanswered questions remain regarding the relative efficacy of bariatric surgery in patients with uncontrolled diabetes. This randomized, controlled, prospective multicenter study was designed to compare intensive medical therapy with surgical treatment (LRYGB or LSG) as a means of improving glycemic control in moderately obese patients (BMI 30-34.9) with type- 2 DM.

Conditions

• Overweight
• Diabetes Type 2

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic Sleeve Gastrectomy
PROCEDURE	Laparoscopic Roux-en-Y Gastric Bypass
DRUG	Advanced Medical Therapy

Timeline

• Start date: 2015-01-01
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2014-01-14
• Last updated: 2019-03-01

Locations

1 site across 1 country: Israel