Prospective randomised controlled trial comparing the efficacy of laparoscopic Roux-en-Y gastric bypass versus laparoscopic sleeve gastrectomy for the management of type 2 diabetes mellitus in obese patients

Not Applicable

Recruiting

• Conditions: Type 2 diabetes mellitus; Obesity; Metabolic and Endocrine - Diabetes; Surgery - Surgical techniques; Diet and Nutrition - Obesity

• Registration Number: ACTRN12611000751976
• Lead Sponsor: Waitemata District Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

Type 2 Diabetes Mellitus for at least 6 months
-Previous failed attempts at weight loss through dieting and exercise
-BMI 35 - 65 kg/m2 for at least 5 years
-Suitable for either of the two surgical procedures
-Able to give informed consent

Exclusion Criteria

-Type 1 diabetes mellitus
-Previous bariatric or oesophagogastric surgery
-Poorly controlled psychiatric disorder
-Myocardial infarction, heart bypass surgery or stroke within 6 months
-Malignancy in last 5 years
-Not suitable for general anaesthesia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Remission of Type 2 diabetes mellitus as follows:-<br><br>Complete remission = Fasting plasma glucose less than 5.6 mmol/L and glycated haemoglobin (HbA1c) less than 6.0% in the absence of active pharmacologic therapy<br><br>Partial remission = Fasting plasma glucose between 5.6 and 6.9 mmol/L and glycated haemoglobin (HbA1c) between 6.0 and 6.5% in the absence of active pharmacologic therapy[At one year and five years after randomisation]