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| Name | Class |
|---|---|
| St. Claraspital AG | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optimal medical treatment and surgery | Active Comparator | 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 | Other | In the study 50 obese patients with CKD 3 andT2DM will be treated using the European Association for Study of Diabetes protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optimal medical treatment and surgery | Procedure |
| ||
| Optimal medical treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Glomerular filtration rate | Renal function measurement by Iohexol clearance | Three years after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Microvascular kidney damage | Microvascular kidney damage measured by Albumin/Creatinine Ratio | 3 years after intervention |
| Glycaemic control | HbA1c and fasting plasma glucose measurements . Five day continuous glucose monitoring |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | from intervention and three years forward |
Inclusion Criteria:
• BMI 28 - 35 kg/m2
Exclusion Criteria:
• Type 1 diabetes or a positive GAD antibody test
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| Name | Affiliation | Role |
|---|---|---|
| Thorell Anders, Professor | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ersta hospital | Stockholm | Stockholm County | 116 28 | Sweden | ||
| St:Claraspital |
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Procedure |
|
| 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 | 3 years after intervention |
| autonomic nervous system function | Autonomic neuropathy will be assessed with the RR intervals on ECG during deep breathing test | 3 years after intervention |
| diabetic eyes complications | Using retinal photos and using the International Clinical Diabetic Retinopathy Disease Severity Scale | 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. | 3 years after intervention |
| Lipids | Total cholesterol, low density lipoprotein, high density lipoprotein cholesterol and triglycerides will be measured | 3 years after intervention |
| Quality of life score | Quality of life will be measured by the general health 36-item Health Survey (SF-36) | three years after intervention |
| Basel |
| 4058 |
| Switzerland |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |