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

Not Applicable

Withdrawn

• Conditions: Diabetic Kidney Disease
• Interventions: Procedure: Optimal medical treatment and surgery; Procedure: Optimal medical treatment

• Registration Number: NCT02011178
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-12
• Study First Posted: 2013-12-13
• Study Start: 2014-03
• Primary Completion: 2017-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-10
• Last Update Posted: 2017-03-13
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Optimal medical treatment and surgery	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	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

Primary Outcome Measures

Name	Time	Method
Glomerular filtration rate	Three years after intervention	Renal function measurement by Iohexol clearance

Secondary Outcome Measures

Name	Time	Method
Microvascular kidney damage	3 years after intervention	Microvascular kidney damage measured by Albumin/Creatinine Ratio
Glycaemic control	3 years after intervention	HbA1c and fasting plasma glucose measurements . Five day continuous glucose monitoring
peripheral nervous system function	3 years after intervention	Michigan Neuropathy Screening Instrument (MNSI) score, which includes two separate assessments: a lower extremity examination that includes inspection of the feet to identify deformities, dry skin, calluses, infection, fissure, or ulcers, and assessment of vibratory sensation and ankle reflexes
autonomic nervous system function	3 years after intervention	Autonomic neuropathy will be assessed with the RR intervals on ECG during deep breathing test
diabetic eyes complications	3 years after intervention	Using retinal photos and using the International Clinical Diabetic Retinopathy Disease Severity Scale
blood preassure	3 years after intervention	Blood pressure will be recorded with calibrated and validated electronic blood pressure equipment and appropriate sized cuff. Patients will sit in a chair in a quiet room for 5 minutes.
Lipids	3 years after intervention	Total cholesterol, low density lipoprotein, high density lipoprotein cholesterol and triglycerides will be measured

Trial Locations

Locations (2)

St:Claraspital; 🇨🇭 Basel, Switzerland

Ersta hospital; 🇸🇪 Stockholm, Sweden