Prevention of Microvascular Complications in Overweight Diabetics With Surgery or Best Medicine (PROMISE)
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.
|Diabetic Kidney Disease||Procedure: Optimal medical treatment and surgery Procedure: Optimal medical treatment|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Prevention of Microvascular Complications in Overweight Diabetics With Surgery or Best Medicine; a Prospectivee, Randomized, Multicenter Study|
- Glomerular filtration rate [ Time Frame: Three years after intervention ]Renal function measurement by Iohexol clearance
- Microvascular kidney damage [ Time Frame: 3 years after intervention ]Microvascular kidney damage measured by Albumin/Creatinine Ratio
- Glycaemic control [ Time Frame: 3 years after intervention ]HbA1c and fasting plasma glucose measurements . Five day continuous glucose monitoring
- peripheral nervous system function [ Time Frame: 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 [ Time Frame: 3 years after intervention ]Autonomic neuropathy will be assessed with the RR intervals on ECG during deep breathing test
- diabetic eyes complications [ Time Frame: 3 years after intervention ]Using retinal photos and using the International Clinical Diabetic Retinopathy Disease Severity Scale
- blood preassure [ Time Frame: 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 [ Time Frame: 3 years after intervention ]Total cholesterol, low density lipoprotein, high density lipoprotein cholesterol and triglycerides will be measured
- health economics [ Time Frame: 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 [ Time Frame: three years after intervention ]Quality of life will be measured by the general health 36-item Health Survey (SF-36)
|Study Start Date:||March 2014|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Active Comparator: 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.
|Procedure: Optimal medical treatment and surgery|
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
|Procedure: Optimal medical treatment|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02011178
|Stockholm, Sweden, 116 28|
|Basel, Switzerland, 4058|
|Principal Investigator:||Thorell Anders, Professor||Karolinska Institutet|