An interventional study of Optimal medical treatment and surgery and Optimal medical treatment in Diabetic Kidney Disease, sponsored by Karolinska Institutet. Withdrawn at 2 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-03-13.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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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BMI 28 - 35 kg/m2
Exclusion Criteria:
Type 1 diabetes or a positive GAD antibody test
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.
Procedure: 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
Procedure: Optimal medical treatment
Glomerular filtration rate
Renal function measurement by Iohexol clearance
Time frame: Three years after intervention
Microvascular kidney damage
Microvascular kidney damage measured by Albumin/Creatinine Ratio
Time frame: 3 years after intervention
Glycaemic control
HbA1c and fasting plasma glucose measurements . Five day continuous glucose monitoring
Time frame: 3 years after intervention
peripheral nervous system function
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
Time frame: 3 years after intervention
autonomic nervous system function
Autonomic neuropathy will be assessed with the RR intervals on ECG during deep breathing test
Time frame: 3 years after intervention
diabetic eyes complications
Using retinal photos and using the International Clinical Diabetic Retinopathy Disease Severity Scale
Time frame: 3 years after intervention
blood preassure
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.
Time frame: 3 years after intervention
Lipids
Total cholesterol, low density lipoprotein, high density lipoprotein cholesterol and triglycerides will be measured
Time frame: 3 years after intervention
health economics
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
Time frame: from intervention and three years forward
Quality of life score
Quality of life will be measured by the general health 36-item Health Survey (SF-36)
Time frame: three years after intervention
This study is withdrawn, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Karolinska Institutet