Diabetic Kidney Disease Clinical Trial
Official title:
Prevention of Microvascular Complications in Overweight Diabetics With Surgery or Best Medicine; a Prospectivee, Randomized, Multicenter Study
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.
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