Clinical trial NCT02011178: Prevention of Microvascular Complications in Overweight Diabetics With Surgery or Best Medicine
Official title: Prevention of Microvascular Complications in Overweight Diabetics With Surgery or Best Medicine; a Prospectivee, Randomized, Multicenter Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetic Kidney Disease
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: St. Claraspital AG
First posted: 2013-12-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* • BMI 28 - 35 kg/m2

  * 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:

* • Type 1 diabetes or a positive GAD antibody test

  * 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

Primary outcomes:
measure: Glomerular filtration rate
timeFrame: Three years after intervention
Secondary outcomes:
measure: Microvascular kidney damage
timeFrame: 3 years after intervention
measure: Glycaemic control
timeFrame: 3 years after intervention
measure: peripheral nervous system function
timeFrame: 3 years after intervention
measure: autonomic nervous system function
timeFrame: 3 years after intervention
measure: diabetic eyes complications
timeFrame: 3 years after intervention
measure: blood preassure
timeFrame: 3 years after intervention
measure: Lipids
timeFrame: 3 years after intervention
Other outcomes:
measure: health economics
timeFrame: from intervention and three years forward
measure: Quality of life score
timeFrame: three years after intervention
Locations:
city: Stockholm
country: Sweden
facility: Ersta hospital
city: Basel
country: Switzerland
facility: St:Claraspital
Study officials:
affiliation: Karolinska Institutet
name: Thorell Anders, Professor
role: PRINCIPAL_INVESTIGATOR
References: