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| ID | Type | Description | Link |
|---|---|---|---|
| CAAE - 37013420500000070 | Other Identifier | Institutional Review Board |
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Proven therapy for DKD is primarily limited to RAAS blockers and SLGT2i. Weight reduction has the potential to become an additional and much needed treatment option. Of all the weight reduction strategies metabolic surgery is suited to be the most effective. Yet no study has of yet compared the effect of metabolic surgery against best medical treatment on the progression of DKD. This pilot trial is designed to be the first determine the efficacy of metabolic surgery in slowing progression of DKD as compared to best medical therapy. The study design will address all the major limitations previously documented, including the major dilemma of estimating versus measuring GFR. Of note, the study's design will allow its sample size to be adjusted upward using an adaptive design if necessary, to achieve statistical significance. It will also inform study design and sample size issues for all future studies in this field. The payoff of establishing metabolic surgery as a new and effective intervention to slow progression to ESRD would be great in terms of reducing patient suffering and societal costs.
This will be an open-label, randomized trial involving sixty (60) patients with diabetic kidney disease (DKD) and obesity who will undergo Roux-en-Y gastric bypass (RYGB) in the intervention arm or receive best medical treatment (BMT) in the control arm.
The aim of this prospective, open, randomized study is to evaluate the efficacy and safety of RYGB surgery versus best medical treatment on the progression of DKD in patients with type 2 diabetes and obesity.
This will be an open-label, randomized trial involving sixty (60) patients with DKD and obesity who will undergo RYGB (intervention arm) or receive BMT (control arm).
Thirty (30) obese patients with DKD will undergo gastric bypass. Patients will also receive standard of care medical therapy for DKD (ACEI or ARB + SGLT2i) and T2DM (metformin, glitazones, incretin therapy - DPP4 inhibitor and GLP-1 analogs - and insulin, if necessary). Other comorbidities, such as hypertension and dyslipidemia, will be treated according to the latest recommendations of the ADA. The surgical procedure will consist of a laparoscopic surgery performed by an experienced surgeon (approximately 6000 bariatric surgeries), who is accredited as surgeon of excellence by the Brazilian Society of Bariatric and Metabolic Surgery and Surgical Review and Surgical Review Corporation program since 2009.
Thirty (30) obese patients with DKD will undergo best medical treatment for DKD (ACEI or ARB + SGLT2i) and T2DM (metformin, glitazones, incretin therapy - DPP4 inhibitor and GLP-1 analogs - and insulin, if necessary). Other comorbidities, such as hypertension and dyslipidemia, will be treated according to the latest recommendations of the ADA.
Regarding medication therapy: Metformin will be maintained in the postoperative period while fasting glycemia is above 100 mg/dL unless contraindicated. Anti-antihypertensive drugs and medications for dyslipidemia will be maintained in the postoperative period, unless contraindicated. Micronutrient supplementation (vitamins and mineral salts) will be prescribed to all patients undergoing metabolic surgery. Patients allocated to the control group will receive the same supplementation if necessary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RYGB (intervention arm) | Experimental | Thirty (30) obese patients with DKD will undergo gastric bypass. Patients will also receive standard of care medical therapy for DKD (ACEI or ARB + SGLT2i) and T2DM (metformin, glitazones, incretin therapy - DPP4 inhibitor and GLP-1 analogs - and insulin, if necessary). Other comorbidities, such as hypertension and dyslipidemia, will be treated according to the latest recommendations of the ADA. The surgical procedure will consist of a laparoscopic surgery performed by an experienced surgeon (approximately 6000 bariatric surgeries), who is accredited as surgeon of excellence by the Brazilian Society of Bariatric and Metabolic Surgery and Surgical Review and Surgical Review Corporation program since 2009. |
|
| BMT (control arm). | Active Comparator | Thirty (30) obese patients with DKD will undergo best medical treatment for DKD (ACEI or ARB + SGLT2i) and T2DM (metformin, glitazones, incretin therapy - DPP4 inhibitor and GLP-1 analogs - and insulin, if necessary). Other comorbidities, such as hypertension and dyslipidemia, will be treated according to the latest recommendations of the ADA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roux-en-Y gastric bypass | Procedure |
Expected surgical time: 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Mean differenceGlomerular filtration rate (GFR) | Mean difference in GFR between BMT and RYGB at the pre-specified time points of 12 and 36 months after randomization | At 12 and 36 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Change in twenty-four hour urinary albumin/protein excretion | Change in 24h urinary albumin/protein excretion | From baseline to 12 and 36 months |
| Improvements in micro- or macroalbuminuria | Proportion of patients who achieve improvements in micro- or macroalbuminuria from baseline to 12 and 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cristina M Aboud, RN, MSc | Contact | +551135491187 | cmamedio@haoc.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Ricardo V Cohen, MD, PhD | Oswaldo Cruz German Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro especializado em Obesidade e Diabetes do Hospital Alemão Oswaldo Cruz | Recruiting | São Paulo | São Paulo | 01323-020 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20150934 | Result | Atkins RC, Zimmet P. Diabetic kidney disease: act now or pay later. Kidney Int. 2010 Mar;77(5):375-7. doi: 10.1038/ki.2009.509. No abstract available. | |
| 11304102 | Result | Mann JF, Gerstein HC, Pogue J, Bosch J, Yusuf S. Renal insufficiency as a predictor of cardiovascular outcomes and the impact of ramipril: the HOPE randomized trial. Ann Intern Med. 2001 Apr 17;134(8):629-36. doi: 10.7326/0003-4819-134-8-200104170-00007. |
| Label | URL |
|---|---|
| Obesity and Diabetes Center | View source |
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This will be an open-label, randomized trial involving sixty (60) patients with DKD and obesity who will undergo RYGB (intervention arm) or receive BMT (control arm).
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|
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| Best medical treatment | Drug | Patients will also receive standard of care medical therapy for DKD (ACEI or ARB + SGLT2i) and T2DM (metformin, glitazones, incretin therapy - DPP4 inhibitor and GLP-1 analogs - and insulin, if necessary). |
|
|
| From baseline to 12 and 36 months |
| Change in CKD stage and CKD prognostic risk | Change in CKD stage and CKD prognostic risk from baseline to month 12 and 36 | From baseline to 12 and 36 months |
| Change in GFR, eGFR and 24 hr creatinine clearance | Change in GFR, eGFR and 24 hr creatinine clearance from baseline to months 12 and 36 | From baseline to 12 and 36 months |
| Proportion of participants with ≥30%, ≥40%, and ≥50% reduction in GFR measurements | Proportion of participants with ≥30%, ≥40%, and ≥50% reduction in GFR measurements (GFR, eGFR and 24 hr creatinine clearance) from baseline to months 12 and 36 | From baseline to 12 and 36 months |
| Decline in eGFR, sustained low eGFR, kidney transplantation, maintenance dialysis, and kidney death | Time to occurrence of sustained % decline in eGFR, sustained low eGFR, kidney transplantation, maintenance dialysis, and kidney death | Time to occurrence (from baseline) |
| Maintenance dialysis, kidney transplantation, kidney death, and GFR < 15 ml/min | Individual and composite endpoints of maintenance dialysis, kidney transplantation, kidney death, and GFR < 15 ml/min at 12 and 36 months | At 12 and 36 months after randomization |
| Change in body weight | Change in body weight from baseline to months 12 and 36 | From baseline to 12 and 36 months |
| Change in body mass index | Change in body mass index from baseline to months 12 and 36 | From baseline to 12 and 36 months |
| Change in waist circumference | Change in waist circumference from baseline to months 12 and 36 | From baseline to 12 and 36 months |
| Medications to maintain optimal diabetes and blood pressure control | Number and dose of medications to maintain optimal diabetes and blood pressure control from baseline to months 12 and 36 | From baseline to 12 and 36 months |
| Change in fasting glucose | Change in fasting glucose from baseline to months 12 and 36 | From baseline to 12 and 36 months |
| Change in HbA1c | Change in HbA1c from baseline to months 12 and 36 | From baseline to 12 and 36 months |
| Change in basal insulin | Change in basal insulin from baseline to months 12 and 36 | From baseline to 12 and 36 months |
| Change in homeostasis model assessment (HOMA) scores | Change in homeostasis model assessment (HOMA) scores from baseline to months 12 and 36 | From baseline to 12 and 36 months |
| Remission in type 2 diabetes | Achievement of partial or complete remission in type 2 diabetes by months 12 and 36 | At 12 and 36 months after randomization |
| Change in blood pressure | Change in blood pressure from baseline to months 12 and 36 | From baseline to 12 and 36 months |
| Hypoglycemic adverse events | Number of patients with confirmed or symptomatic hypoglycemic adverse events from baseline to months 12 and 36 | From baseline to 12 and 36 months |
| Changes in total cholesterol, triglycerides, LDL and HDL levels | Changes in total cholesterol, triglycerides, LDL and HDL levels from baseline to months 12 and 36 | From baseline to 12 and 36 months |
| Number of participants achieving LDL < 100 mg/dL and HDL > 40mg/dL | Number of participants achieving LDL < 100 mg/dL and HDL > 40mg/dL from baseline to months 12 and 36 | From baseline to 12 and 36 months |
| Changes in serum calcium and phosphorus, | Changes in serum calcium and phosphorus from baseline to months 12 and 36 | From baseline to 12 and 36 months |
| Change in parathyroid hormone (PTH) | Change in parathyroid hormone (PTH) from baseline to months 12 and 36 | From baseline to 12 and 36 months |
| Change in mineral bone density | Change in mineral bone density from baseline to months 12 and 36 | From baseline to 12 and 36 months |
| Change in quality of life | Change in quality of life measured by SF-36 questionnaire from baseline to months 12 and 36 | From baseline to 12 and 36 months |
| Adverse events | Number of patients with adverse events from baseline to months 12 and 36 | From baseline to 12 and 36 months |
| Acute kidney injury | Number of episodes of acute kidney injury from baseline to months 12 and 36 | From baseline to 12 and 36 months |
| Adverse cardiovascular events (nonfatal stroke, nonfatal MI, cardiovascular death) | Composite of major adverse cardiovascular events (nonfatal stroke, nonfatal MI, cardiovascular death) from baseline to months 12 and 36 | From baseline to 12 and 36 months |
| Mortality | Total mortality from baseline to months 12 and 36 | From baseline to 12 and 36 months |
| Days hospitalized | Number of days hospitalized from baseline to months 12 and 36 | From baseline to 12 and 36 months |
| Change in urinary volume | Change in urinary volume from baseline to months 12 and 36 | From baseline to 12 and 36 months |
| Change in calcium and oxalate excretion | Change in calcium and oxalate excretion from baseline to months 12 and 36 | From baseline to 12 and 36 months |
| High sensitivity c-reactive protein | Change in high sensitivity c-reactive protein from baseline to months 12 and 36 | From baseline to 12 and 36 months |
| Change in muscle strength | Change in muscle strength using one repetition maximum (1-RM) from baseline to months12 and 36 | From baseline to 12 and 36 months |
| Kidney volumes | Change in kidney volumes from baseline to months 12 and 36 | From baseline to 12 and 36 months |
| Change in ventricular mass | Change in left and right ventricular mass from baseline to months 12 and 36 | From baseline to 12 and 36 months |
| Change in ejection fraction | Change in left ventricular ejection fraction from baseline to months 12 and 36 | From baseline to 12 and 36 months |
| Costs of care and health care utilization | Costs of care and health care utilization from baseline to months 12 and 36 | From baseline to 12 and 36 months |
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| 30443719 | Result | Cohen JB, Tewksbury CM, Torres Landa S, Williams NN, Dumon KR. National Postoperative Bariatric Surgery Outcomes in Patients with Chronic Kidney Disease and End-Stage Kidney Disease. Obes Surg. 2019 Mar;29(3):975-982. doi: 10.1007/s11695-018-3604-2. |
| 18701613 | Result | Nasr SH, D'Agati VD, Said SM, Stokes MB, Largoza MV, Radhakrishnan J, Markowitz GS. Oxalate nephropathy complicating Roux-en-Y Gastric Bypass: an underrecognized cause of irreversible renal failure. Clin J Am Soc Nephrol. 2008 Nov;3(6):1676-83. doi: 10.2215/CJN.02940608. Epub 2008 Aug 13. |
| 31753796 | Result | Sundbom M, Naslund E, Vidarsson B, Thorell A, Ottoson J. Low overall mortality during 10 years of bariatric surgery: nationwide study on 63,469 procedures from the Scandinavian Obesity Registry. Surg Obes Relat Dis. 2020 Jan;16(1):65-70. doi: 10.1016/j.soard.2019.10.012. Epub 2019 Oct 21. |
| 27222550 | Result | Cummings DE, Cohen RV. Bariatric/Metabolic Surgery to Treat Type 2 Diabetes in Patients With a BMI <35 kg/m2. Diabetes Care. 2016 Jun;39(6):924-33. doi: 10.2337/dc16-0350. |
| 27222547 | Result | Batterham RL, Cummings DE. Mechanisms of Diabetes Improvement Following Bariatric/Metabolic Surgery. Diabetes Care. 2016 Jun;39(6):893-901. doi: 10.2337/dc16-0145. |
| 27189354 | Result | Cohen RV, Shikora S, Petry T, Caravatto PP, Le Roux CW. The Diabetes Surgery Summit II Guidelines: a Disease-Based Clinical Recommendation. Obes Surg. 2016 Aug;26(8):1989-91. doi: 10.1007/s11695-016-2237-6. |
| 26369473 | Result | Mingrone G, Panunzi S, De Gaetano A, Guidone C, Iaconelli A, Nanni G, Castagneto M, Bornstein S, Rubino F. Bariatric-metabolic surgery versus conventional medical treatment in obese patients with type 2 diabetes: 5 year follow-up of an open-label, single-centre, randomised controlled trial. Lancet. 2015 Sep 5;386(9997):964-73. doi: 10.1016/S0140-6736(15)00075-6. |
| 22723580 | Result | Cohen RV, Pinheiro JC, Schiavon CA, Salles JE, Wajchenberg BL, Cummings DE. Effects of gastric bypass surgery in patients with type 2 diabetes and only mild obesity. Diabetes Care. 2012 Jul;35(7):1420-8. doi: 10.2337/dc11-2289. |
| 19808241 | Result | Navaneethan SD, Yehnert H, Moustarah F, Schreiber MJ, Schauer PR, Beddhu S. Weight loss interventions in chronic kidney disease: a systematic review and meta-analysis. Clin J Am Soc Nephrol. 2009 Oct;4(10):1565-74. doi: 10.2215/CJN.02250409. Epub 2009 Sep 17. |
| 28077412 | Result | Cohen RV, Pereira TV, Aboud CM, Caravatto PP, Petry TB, Correa JL, Schiavon CA, Correa M, Pompilio CE, Pechy FN, le Roux CW; MOMS Study Investigators. Microvascular Outcomes after Metabolic Surgery (MOMS) in patients with type 2 diabetes mellitus and class I obesity: rationale and design for a randomised controlled trial. BMJ Open. 2017 Jan 11;7(1):e013574. doi: 10.1136/bmjopen-2016-013574. |
| 15273542 | Result | Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. |
| 40663401 | Derived | Friedman AN, Chang AR, Chuah LL, Favre GA, Grangeon-Chapon C, Lane KA, Li Y, le Roux CW, Lieske JC, Morales E, Porrini E, Chagnac A. Measurement, Estimation, and Correlates of the GFR before and after Bariatric Surgery. J Am Soc Nephrol. 2026 Jan 1;37(1):110-119. doi: 10.1681/ASN.0000000797. Epub 2025 Jul 15. |
| Oswaldo Cruz German Hospital | View source |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D051436 | Renal Insufficiency, Chronic |
| D003920 | Diabetes Mellitus |
| D009765 | Obesity |
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D048909 | Diabetes Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D015390 | Gastric Bypass |
| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D005763 | Gastroenterostomy |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D013505 | Digestive System Surgical Procedures |
Not provided
Not provided