Diabetic Kidney Disease
Conditions
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.
Interventions
PROCEDUREOptimal medical treatment and surgery
PROCEDUREOptimal medical treatment
Sponsors
St. Claraspital AG
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glomerular filtration rate | Three years after intervention | Renal function measurement by Iohexol clearance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| diabetic eyes complications | 3 years after intervention | Using retinal photos and using the International Clinical Diabetic Retinopathy Disease Severity Scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| health economics | from intervention and three years forward | Direct healthcare resource consumption. Costs to Governments or Insurance companies plus private expenditure on health. Costs will include primary and secondary surgery, medication, laboratory tests, health provider reimbursement, private prescription charges and co-payments for medications |
| Quality of life score | three years after intervention | Quality of life will be measured by the general health 36-item Health Survey (SF-36) |
Countries
Sweden, Switzerland
Outcome results
None listed