Randomized Study Comparing Metabolic Surgery With Intensive Medical Therapy to Treat Diabetic Kidney Disease
NCT ID: NCT04626323
Last Updated: 2021-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2021-05-25
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
RYGB (intervention 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.
Roux-en-Y gastric bypass
1. Pneumoperitoneum closed with Veress needle
2. Identification of Treitz angle
3. Measurement of biliary loop (50 cm)
4. Bowel transection with linear stapler (white load)
5. Measurement of the alimentary limb (100 cm)
6. Laterolateral Entero-anastomoses (white load)
7. Construction of gastric pouch distant about 3 cm from the esophageal-gastric junction with stomach section in the small curvature.
8. Linear cutting anastomosis (gastrojejunostomy) from about 1 to 1.2 cm
9. Anastomosis integrity evaluation by methylene blue test and/or perioperative air.
Expected surgical time: 60 minutes
Best medical treatment
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).
BMT (control arm).
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.
Best medical treatment
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Roux-en-Y gastric bypass
1. Pneumoperitoneum closed with Veress needle
2. Identification of Treitz angle
3. Measurement of biliary loop (50 cm)
4. Bowel transection with linear stapler (white load)
5. Measurement of the alimentary limb (100 cm)
6. Laterolateral Entero-anastomoses (white load)
7. Construction of gastric pouch distant about 3 cm from the esophageal-gastric junction with stomach section in the small curvature.
8. Linear cutting anastomosis (gastrojejunostomy) from about 1 to 1.2 cm
9. Anastomosis integrity evaluation by methylene blue test and/or perioperative air.
Expected surgical time: 60 minutes
Best medical treatment
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diabetic kidney disease as defined by an estimated glomerular filtration rate (eGFR) (as estimated by CKD-EPI creatinine + cystatin C equation)72 between 45-59l/min/1.73m2 and macroalbuminuria (≥ 300 mg/g) in a 24 hr urine sample
* BMI ≥30-40 kg/m2
* Fasting C-peptide over 1 ng/ml
* Negative glutamic acid decarboxylase autoantibodies test
* Patients having received accurate information about the surgery and requesting the procedure
* Patients having understood and accepted the need for long-term medical and surgical follow-up
* Effective method of contraception in women of child-bearing age
* Signed informed consent document
Exclusion Criteria
* Autoimmune diabetes/type 1 diabetes
* Previous abdominal operations that would complicate a metabolic surgery or increase surgical risk
* Previous malabsorptive and restrictive surgeries
* Malabsorptive syndromes and inflammatory bowel disease
* Significant and/or severe hepatic disease that may complicate metabolic surgery
* Pregnancy or women of childbearing age without effective contraceptive
* Recent history of neoplasia (\< 5 years), except for non-melanoma skin neoplasms
* History of liver cirrhosis, active chronic hepatitis, active hepatitis B or hepatitis C
* Major cardiovascular event in the last 6 months
* Current angina
* Pulmonary embolism or severe thrombophlebitis in the last 2 years
* Positive HIV serum testing
* Mental incapacity or severe mental illness
* Severe psychiatric disorders that would complicate follow-up after randomization
* Alcoholism or illicit drug use
* Uncontrolled coagulopathy
* Participation in other clinical trials in the past 30 days
* Inability to tolerate RAAS blockers and/or SGLT2i
* Iodine allergy
* History of acute kidney injury requiring renal replacement therapy
* Dialysis dependency
* Kidney transplantation
* Use of immunosuppressive drugs, chemotherapy and/or radiotherapy
* Any disorder which, in the opinion of the investigator, might jeopardize subject's safety or compliance with the protocol
30 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Alemão Oswaldo Cruz
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ricardo Vitor Cohen, MD
Ricardo Vitor Cohen, MD, PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ricardo V Cohen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Oswaldo Cruz German Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centro especializado em Obesidade e Diabetes do Hospital Alemão Oswaldo Cruz
São Paulo, São Paulo, Brazil
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Cristina M Aboud, RN, MSc
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Afkarian M, Sachs MC, Kestenbaum B, Hirsch IB, Tuttle KR, Himmelfarb J, de Boer IH. Kidney disease and increased mortality risk in type 2 diabetes. J Am Soc Nephrol. 2013 Feb;24(2):302-8. doi: 10.1681/ASN.2012070718. Epub 2013 Jan 29.
Foley RN, Collins AJ. The growing economic burden of diabetic kidney disease. Curr Diab Rep. 2009 Dec;9(6):460-5. doi: 10.1007/s11892-009-0075-9.
(IHME) IfHMaE. Findings from the Global Burden of Disease Study 2017. Seattle, WA2018.
World Health Organization Diabetes. 2018; https://www.who.int/news-room/fact-sheets/detail/diabetes.
Alicic RZ, Rooney MT, Tuttle KR. Diabetic Kidney Disease: Challenges, Progress, and Possibilities. Clin J Am Soc Nephrol. 2017 Dec 7;12(12):2032-2045. doi: 10.2215/CJN.11491116. Epub 2017 May 18.
American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2012 Jan;35 Suppl 1(Suppl 1):S64-71. doi: 10.2337/dc12-s064. No abstract available.
Eckel RH, Kahn SE, Ferrannini E, Goldfine AB, Nathan DM, Schwartz MW, Smith RJ, Smith SR. Obesity and type 2 diabetes: what can be unified and what needs to be individualized? J Clin Endocrinol Metab. 2011 Jun;96(6):1654-63. doi: 10.1210/jc.2011-0585.
Brenner BM, Cooper ME, de Zeeuw D, Keane WF, Mitch WE, Parving HH, Remuzzi G, Snapinn SM, Zhang Z, Shahinfar S; RENAAL Study Investigators. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med. 2001 Sep 20;345(12):861-9. doi: 10.1056/NEJMoa011161.
Lewis EJ, Hunsicker LG, Clarke WR, Berl T, Pohl MA, Lewis JB, Ritz E, Atkins RC, Rohde R, Raz I; Collaborative Study Group. Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes. N Engl J Med. 2001 Sep 20;345(12):851-60. doi: 10.1056/NEJMoa011303.
Perkovic V, Jardine MJ, Neal B, Bompoint S, Heerspink HJL, Charytan DM, Edwards R, Agarwal R, Bakris G, Bull S, Cannon CP, Capuano G, Chu PL, de Zeeuw D, Greene T, Levin A, Pollock C, Wheeler DC, Yavin Y, Zhang H, Zinman B, Meininger G, Brenner BM, Mahaffey KW; CREDENCE Trial Investigators. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. N Engl J Med. 2019 Jun 13;380(24):2295-2306. doi: 10.1056/NEJMoa1811744. Epub 2019 Apr 14.
de Boer IH, Rue TC, Hall YN, Heagerty PJ, Weiss NS, Himmelfarb J. Temporal trends in the prevalence of diabetic kidney disease in the United States. JAMA. 2011 Jun 22;305(24):2532-9. doi: 10.1001/jama.2011.861.
Friedman AN, Wolfe B. Is Bariatric Surgery an Effective Treatment for Type II Diabetic Kidney Disease? Clin J Am Soc Nephrol. 2016 Mar 7;11(3):528-35. doi: 10.2215/CJN.07670715. Epub 2015 Oct 8.
Friedman AN, Moe S, Fadel WF, Inman M, Mattar SG, Shihabi Z, Quinney SK. Predicting the glomerular filtration rate in bariatric surgery patients. Am J Nephrol. 2014;39(1):8-15. doi: 10.1159/000357231. Epub 2013 Dec 19.
Foster MC, Hwang SJ, Porter SA, Massaro JM, Hoffmann U, Fox CS. Fatty kidney, hypertension, and chronic kidney disease: the Framingham Heart Study. Hypertension. 2011 Nov;58(5):784-90. doi: 10.1161/HYPERTENSIONAHA.111.175315. Epub 2011 Sep 19.
Wiggins JE, Goyal M, Sanden SK, Wharram BL, Shedden KA, Misek DE, Kuick RD, Wiggins RC. Podocyte hypertrophy, "adaptation," and "decompensation" associated with glomerular enlargement and glomerulosclerosis in the aging rat: prevention by calorie restriction. J Am Soc Nephrol. 2005 Oct;16(10):2953-66. doi: 10.1681/ASN.2005050488. Epub 2005 Aug 24.
D'Agati VD, Chagnac A, de Vries AP, Levi M, Porrini E, Herman-Edelstein M, Praga M. Obesity-related glomerulopathy: clinical and pathologic characteristics and pathogenesis. Nat Rev Nephrol. 2016 Aug;12(8):453-71. doi: 10.1038/nrneph.2016.75. Epub 2016 Jun 6.
Stern JS, Gades MD, Wheeldon CM, Borchers AT. Calorie restriction in obesity: prevention of kidney disease in rodents. J Nutr. 2001 Mar;131(3):913S-917S. doi: 10.1093/jn/131.3.913S.
Nangaku M, Izuhara Y, Usuda N, Inagi R, Shibata T, Sugiyama S, Kurokawa K, van Ypersele de Strihou C, Miyata T. In a type 2 diabetic nephropathy rat model, the improvement of obesity by a low calorie diet reduces oxidative/carbonyl stress and prevents diabetic nephropathy. Nephrol Dial Transplant. 2005 Dec;20(12):2661-9. doi: 10.1093/ndt/gfi096. Epub 2005 Sep 27.
Ohtomo S, Izuhara Y, Nangaku M, Dan T, Ito S, van Ypersele de Strihou C, Miyata T. Body weight control by a high-carbohydrate/low-fat diet slows the progression of diabetic kidney damage in an obese, hypertensive, type 2 diabetic rat model. J Obes. 2010;2010:136502. doi: 10.1155/2010/136502. Epub 2010 Feb 17.
Gugliucci A, Kotani K, Taing J, Matsuoka Y, Sano Y, Yoshimura M, Egawa K, Horikawa C, Kitagawa Y, Kiso Y, Kimura S, Sakane N. Short-term low calorie diet intervention reduces serum advanced glycation end products in healthy overweight or obese adults. Ann Nutr Metab. 2009;54(3):197-201. doi: 10.1159/000217817. Epub 2009 May 6.
Wycherley TP, Brinkworth GD, Noakes M, Buckley JD, Clifton PM. Effect of caloric restriction with and without exercise training on oxidative stress and endothelial function in obese subjects with type 2 diabetes. Diabetes Obes Metab. 2008 Nov;10(11):1062-73. doi: 10.1111/j.1463-1326.2008.00863.x. Epub 2008 Apr 22.
Seshadri P, Iqbal N, Stern L, Williams M, Chicano KL, Daily DA, McGrory J, Gracely EJ, Rader DJ, Samaha FF. A randomized study comparing the effects of a low-carbohydrate diet and a conventional diet on lipoprotein subfractions and C-reactive protein levels in patients with severe obesity. Am J Med. 2004 Sep 15;117(6):398-405. doi: 10.1016/j.amjmed.2004.04.009.
Tuck ML, Sowers J, Dornfeld L, Kledzik G, Maxwell M. The effect of weight reduction on blood pressure, plasma renin activity, and plasma aldosterone levels in obese patients. N Engl J Med. 1981 Apr 16;304(16):930-3. doi: 10.1056/NEJM198104163041602.
Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
Laferrere B, Teixeira J, McGinty J, Tran H, Egger JR, Colarusso A, Kovack B, Bawa B, Koshy N, Lee H, Yapp K, Olivan B. Effect of weight loss by gastric bypass surgery versus hypocaloric diet on glucose and incretin levels in patients with type 2 diabetes. J Clin Endocrinol Metab. 2008 Jul;93(7):2479-85. doi: 10.1210/jc.2007-2851. Epub 2008 Apr 22.
Gregg EW, Chen H, Wagenknecht LE, Clark JM, Delahanty LM, Bantle J, Pownall HJ, Johnson KC, Safford MM, Kitabchi AE, Pi-Sunyer FX, Wing RR, Bertoni AG; Look AHEAD Research Group. Association of an intensive lifestyle intervention with remission of type 2 diabetes. JAMA. 2012 Dec 19;308(23):2489-96. doi: 10.1001/jama.2012.67929.
UK Prospective Diabetes Study (UKPDS). X. Urinary albumin excretion over 3 years in diet-treated type 2, (non-insulin-dependent) diabetic patients, and association with hypertension, hyperglycaemia and hypertriglyceridaemia. Diabetologia. 1993 Oct;36(10):1021-9.
Heshka S, Anderson JW, Atkinson RL, Greenway FL, Hill JO, Phinney SD, Kolotkin RL, Miller-Kovach K, Pi-Sunyer FX. Weight loss with self-help compared with a structured commercial program: a randomized trial. JAMA. 2003 Apr 9;289(14):1792-8. doi: 10.1001/jama.289.14.1792.
Dansinger ML, Gleason JA, Griffith JL, Selker HP, Schaefer EJ. Comparison of the Atkins, Ornish, Weight Watchers, and Zone diets for weight loss and heart disease risk reduction: a randomized trial. JAMA. 2005 Jan 5;293(1):43-53. doi: 10.1001/jama.293.1.43.
Schiavon CA, Bersch-Ferreira AC, Santucci EV, Oliveira JD, Torreglosa CR, Bueno PT, Frayha JC, Santos RN, Damiani LP, Noujaim PM, Halpern H, Monteiro FLJ, Cohen RV, Uchoa CH, de Souza MG, Amodeo C, Bortolotto L, Ikeoka D, Drager LF, Cavalcanti AB, Berwanger O. Effects of Bariatric Surgery in Obese Patients With Hypertension: The GATEWAY Randomized Trial (Gastric Bypass to Treat Obese Patients With Steady Hypertension). Circulation. 2018 Mar 13;137(11):1132-1142. doi: 10.1161/CIRCULATIONAHA.117.032130. Epub 2017 Nov 13.
Scheurlen KM, Probst P, Kopf S, Nawroth PP, Billeter AT, Muller-Stich BP. Metabolic surgery improves renal injury independent of weight loss: a meta-analysis. Surg Obes Relat Dis. 2019 Jun;15(6):1006-1020. doi: 10.1016/j.soard.2019.03.013. Epub 2019 Mar 20.
Peromaa-Haavisto P, Tuomilehto H, Kossi J, Virtanen J, Luostarinen M, Pihlajamaki J, Kakela P, Victorzon M. Obstructive sleep apnea: the effect of bariatric surgery after 12 months. A prospective multicenter trial. Sleep Med. 2017 Jul;35:85-90. doi: 10.1016/j.sleep.2016.12.017. Epub 2017 Jan 12.
Le Jemtel TH, Samson R, Jaiswal A, Lewine EB, Oparil S. Regression of Left Ventricular Mass After Bariatric Surgery. Curr Hypertens Rep. 2017 Sep;19(9):68. doi: 10.1007/s11906-017-0767-5.
Look AHEAD Research Group; Wing RR. Long-term effects of a lifestyle intervention on weight and cardiovascular risk factors in individuals with type 2 diabetes mellitus: four-year results of the Look AHEAD trial. Arch Intern Med. 2010 Sep 27;170(17):1566-75. doi: 10.1001/archinternmed.2010.334.
Schauer PR, Bhatt DL, Kirwan JP, Wolski K, Aminian A, Brethauer SA, Navaneethan SD, Singh RP, Pothier CE, Nissen SE, Kashyap SR; STAMPEDE Investigators. Bariatric Surgery versus Intensive Medical Therapy for Diabetes - 5-Year Outcomes. N Engl J Med. 2017 Feb 16;376(7):641-651. doi: 10.1056/NEJMoa1600869.
Muller-Stich BP, Senft JD, Warschkow R, Kenngott HG, Billeter AT, Vit G, Helfert S, Diener MK, Fischer L, Buchler MW, Nawroth PP. Surgical versus medical treatment of type 2 diabetes mellitus in nonseverely obese patients: a systematic review and meta-analysis. Ann Surg. 2015 Mar;261(3):421-9. doi: 10.1097/SLA.0000000000001014.
Gloy VL, Briel M, Bhatt DL, Kashyap SR, Schauer PR, Mingrone G, Bucher HC, Nordmann AJ. Bariatric surgery versus non-surgical treatment for obesity: a systematic review and meta-analysis of randomised controlled trials. BMJ. 2013 Oct 22;347:f5934. doi: 10.1136/bmj.f5934.
Neff KJ, Elliott JA, Corteville C, Abegg K, Boza C, Lutz TA, Docherty NG, le Roux CW. Effect of Roux-en-Y gastric bypass and diet-induced weight loss on diabetic kidney disease in the Zucker diabetic fatty rat. Surg Obes Relat Dis. 2017 Jan;13(1):21-27. doi: 10.1016/j.soard.2016.08.026. Epub 2016 Aug 18.
Canney AL, Cohen RV, Elliott JA, M Aboud C, Martin WP, Docherty NG, le Roux CW. Improvements in diabetic albuminuria and podocyte differentiation following Roux-en-Y gastric bypass surgery. Diab Vasc Dis Res. 2020 Jan-Feb;17(1):1479164119879039. doi: 10.1177/1479164119879039. Epub 2019 Nov 14.
O'Brien R, Johnson E, Haneuse S, Coleman KJ, O'Connor PJ, Fisher DP, Sidney S, Bogart A, Theis MK, Anau J, Schroeder EB, Arterburn D. Microvascular Outcomes in Patients With Diabetes After Bariatric Surgery Versus Usual Care: A Matched Cohort Study. Ann Intern Med. 2018 Sep 4;169(5):300-310. doi: 10.7326/M17-2383. Epub 2018 Aug 7.
Young L, Nor Hanipah Z, Brethauer SA, Schauer PR, Aminian A. Long-term impact of bariatric surgery in diabetic nephropathy. Surg Endosc. 2019 May;33(5):1654-1660. doi: 10.1007/s00464-018-6458-8. Epub 2018 Sep 24.
Shulman A, Peltonen M, Sjostrom CD, Andersson-Assarsson JC, Taube M, Sjoholm K, le Roux CW, Carlsson LMS, Svensson PA. Incidence of end-stage renal disease following bariatric surgery in the Swedish Obese Subjects Study. Int J Obes (Lond). 2018 Jun;42(5):964-973. doi: 10.1038/s41366-018-0045-x. Epub 2018 Feb 26.
Friedman AN, Wang J, Wahed AS, Docherty NG, Fennern E, Pomp A, Purnell JQ, le Roux CW, Wolfe B. The Association Between Kidney Disease and Diabetes Remission in Bariatric Surgery Patients With Type 2 Diabetes. Am J Kidney Dis. 2019 Dec;74(6):761-770. doi: 10.1053/j.ajkd.2019.05.013. Epub 2019 Jul 19.
Inge TH, Laffel LM, Jenkins TM, Marcus MD, Leibel NI, Brandt ML, Haymond M, Urbina EM, Dolan LM, Zeitler PS; Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) and Treatment Options of Type 2 Diabetes in Adolescents and Youth (TODAY) Consortia. Comparison of Surgical and Medical Therapy for Type 2 Diabetes in Severely Obese Adolescents. JAMA Pediatr. 2018 May 1;172(5):452-460. doi: 10.1001/jamapediatrics.2017.5763.
Imam TH, Fischer H, Jing B, Burchette R, Henry S, DeRose SF, Coleman KJ. Estimated GFR Before and After Bariatric Surgery in CKD. Am J Kidney Dis. 2017 Mar;69(3):380-388. doi: 10.1053/j.ajkd.2016.09.020. Epub 2016 Dec 4.
Friedman AN, Wahed AS, Wang J, Courcoulas AP, Dakin G, Hinojosa MW, Kimmel PL, Mitchell JE, Pomp A, Pories WJ, Purnell JQ, le Roux C, Spaniolas K, Steffen KJ, Thirlby R, Wolfe B. Effect of Bariatric Surgery on CKD Risk. J Am Soc Nephrol. 2018 Apr;29(4):1289-1300. doi: 10.1681/ASN.2017060707. Epub 2018 Jan 15.
Aminian A, Brethauer SA, Kirwan JP, Kashyap SR, Burguera B, Schauer PR. How safe is metabolic/diabetes surgery? Diabetes Obes Metab. 2015 Feb;17(2):198-201. doi: 10.1111/dom.12405. Epub 2014 Nov 19.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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. 2025 Jul 15. doi: 10.1681/ASN.0000000797. Online ahead of print. No abstract available.
Related Links
Access external resources that provide additional context or updates about the study.
Obesity and Diabetes Center
Oswaldo Cruz German Hospital
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CAAE - 37013420500000070
Identifier Type: OTHER
Identifier Source: secondary_id
OBESE-DKD
Identifier Type: -
Identifier Source: org_study_id