Prevention of Microvascular Complications in Overweight Diabetics With Surgery or Best Medicine
NCT ID: NCT02011178
Last Updated: 2017-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2014-03-31
2017-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Optimal medical treatment and surgery
In the study 50 obese patients with CKD 3 andT2DM will be treated using the European Association for Study of Diabetes protocol in combination with RYGB surgery.
Optimal medical treatment and surgery
Optimal medical treatment
In the study 50 obese patients with CKD 3 andT2DM will be treated using the European Association for Study of Diabetes protocol
Optimal medical treatment
Interventions
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Optimal medical treatment and surgery
Optimal medical treatment
Eligibility Criteria
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Inclusion Criteria
* Age: 18-65 years, with T2DM
* Estimated glomerular filtration rate (eGFR; by MDRD) between 30 and 60mL/min/1.73m2
* Urine albumin creatinine ratio (ACR) of at least 30mg/g (microalbuminuria) in first void urine on two separate days.
Exclusion Criteria
* Known renal artery stenosis
* Renal impairment for reasons unrelated to diabetes
* Suspicion of glomerulonephritis as determined by urine sediment (\>10 erythrocytes/visual field)
* Post-renal obstruction diagnosed by ultrasound
* Severe retinopathy (defined as high-risk proliferative diabetic retinopathy and severe visual loss according to the "Early Treatment Diabetic Retinopathy Study Severity Scale")
* Severe DKD (CKD 4 or 5, requirement of renal replacement therapy such as dialysis or kidney transplantation)
* Severe neuropathy (peripheral neuropathy stage 3)
* Unacceptably high risk for general anesthesia
* Prior extensive intra-abdominal surgery making laparoscopy complicated
* Myocardial infarction, cerebrovascular accident, transient ischemic attack, coronary-artery bypass grafting or percutaneous transluminal coronary angioplasty within the previous 6 months
* Cardiac failure (NYHA stage \> 2)
* Inability to stop smoking prior to inclusion
* Pregnancy or breast feeding
18 Years
65 Years
ALL
No
Sponsors
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St. Claraspital AG
OTHER
Karolinska Institutet
OTHER
Responsible Party
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Anders Thorell
Professor
Principal Investigators
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Thorell Anders, Professor
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Ersta hospital
Stockholm, Stockholm County, Sweden
St:Claraspital
Basel, , Switzerland
Countries
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Other Identifiers
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2013/1530-31
Identifier Type: -
Identifier Source: org_study_id
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