NCT02011178

Prevention of Microvascular Complications in Overweight Diabetics With Surgery or Best Medicine

Prevention of Microvascular Complications in Overweight Diabetics With Surgery or Best Medicine; a Prospectivee, Randomized, Multicenter Study

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Background: Diabetic kidney disease (DKD) is chronic and often progresses to kidney failure,heart disease and premature death. Unfortunately, the best medical therapies available for DKD today are ultimately unable to prevent its progression, especially in obese patients.Surgical rerouting of food within the gut with a gastric bypass operation (RYGB), improves diabetes and some of its complications. The investigators propose to investigate whether RYGB in combination with best medical therapy in patients with DKD and obesity prevent further deterioration of kidney function over a 3 years follow up period. Study design: This is an international collaboration with leading centres in Sweden and Switzerland in which100 obese type 2 diabetic patients with established DKD will volunteer to be randomly assigned to receive best medical therapy with RYGB or best medical therapy without surgery. Participants will be 18-65 years with type 2 diabetes and impaired kidney function. Yearly measurements of kidney function will then be done over a period of 3 years as a primary outcome to determine whether differences in DKD can be detectable. The study will also examine and compare a) safety of the interventions, b) the health economic impact on direct healthcare costs and Quality of Life in patients as well as c) the value of a new marker of DKD in determining which patients are most likely to benefit from surgery. Overall the study will strengthen the evidence base guiding clinical decisions about the usefulness of RYGB as an add on therapy to best medical therapy in stopping progressive DKD in patients with obesity and diabetes.

Conditions

• Diabetic Kidney Disease

Interventions

Type	Name	Description
PROCEDURE	Optimal medical treatment and surgery
PROCEDURE	Optimal medical treatment

Timeline

• Start date: 2014-03-01
• Primary completion: 2017-01-01
• Completion: 2017-12-01
• First posted: 2013-12-13
• Last updated: 2017-03-13

Locations

2 sites across 2 countries: Sweden, Switzerland