NCT01821508.

Trial name or title	Not reported
Methods	RCT, parallel group
Participants	BMI 30‐35; patients with microalbuminuria and receiving pharmacological treatment for type 2 diabetes mellitus; diabetes diagnosis not more than 15 years before recruitment
Interventions	Roux‐en‐Y gastric bypass Clinical treatment of type 2 diabetes mellitus (best and most modern available)
Outcomes	Proposed assessment at 24 months unless stated: Quality of life (SF‐36) (12 and 24 months). Glycaemic control (fasting glucose and glycated haemoglobin). Discontinuation of type 2 diabetes mellitus medication. Normalisation of lipids. Normalisation of blood pressure. Normalisation of albumin/creatinine ratio (primary outcome). Retinopathy reversal. Development or worsening of peripheral neuropathy.
Starting date	March 2013; estimated completion date April 2015
Contact information	Ricardo V Cohen, MD, PhD, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil
Study identifier	NCT01821508
Official title	Prospective, Open, Randomized, Unicenter Study Comparing Roux‐en‐Y Gastric Bypass With the Best Clinical Treatment Regarding Improvement of Microvascular Complications of Type 2 Diabetes Mellitus in Obese Patients
Stated purpose of study	To evaluate the effects of Roux‐en‐Y gastric bypass in the control of diabetic nephropathy in diabetic patients with BMI between 30 and 35
Notes	Estimated enrolment 72