AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 2OBESE-DKDNCT04626323

Randomized Study Comparing Metabolic Surgery With Intensive Medical Therapy to Treat Diabetic Kidney Disease

A Phase 2 study testing Roux-en-Y gastric bypass and Best medical treatment in people with Diabetes Mellitus, Type 2 and Kidney Disease, Chronic, run by Hospital Alemão Oswaldo Cruz at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 30 to 70 years
What is being tested?
Roux-en-Y gastric bypass and Best medical treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteBrazil
Study dates
25 May 2021to Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female or male aged ≥30 and ≤70 years
  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • Refusal to participate
  • 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
Show all 25Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Cristina M Aboud, RN, MSc contact

+551135491187

cmamedio@haoc.com.br

Brazil1 site, 1 recruiting

  • Centro especializado em Obesidade e Diabetes do Hospital Alemão Oswaldo Cruz

    São Paulo, São Paulo, 01323-020

    Cristina M Aboud, RN, MSc, 1135491187, cmamedio@haoc.com.br

    Recruiting

Other trials in Brazil

About this study

Official title: Open, Randomized, Unicenter Study Comparing Metabolic Surgery With Intensive Medical Therapy to Treat Diabetic Kidney Disease

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.

Read the detailed description

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.

Being tested
Roux-en-Y gastric bypass, Best medical treatment
Keywords
Diabetes Mellitus, Type 2, Diabetes Mellitus, Obesity, Metabolic surgery, Gastric bypass, Diabetic kidney disease
Medical subject headings
Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic, Diabetes Mellitus, Obesity, Diabetic Nephropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Roux-en-Y gastric bypassProcedure or surgery

    Also called RYGB

    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 treatmentDrug

    Also called BMT

    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).

Study groups in NCT04626323
Study groupRoleWhat they receive
RYGB (intervention arm)ExperimentalThirty (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.
Receives: Procedure: Roux-en-Y gastric bypass; Drug: Best medical treatment
BMT (control arm).Active comparatorThirty (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.
Receives: Drug: Best medical treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: At 12 and 36 months after randomization

Secondary outcomes (37)

  1. Change in twenty-four hour urinary albumin/protein excretion

    Change in 24h urinary albumin/protein excretion

    Measured: From baseline to 12 and 36 months

  2. Improvements in micro- or macroalbuminuria

    Proportion of patients who achieve improvements in micro- or macroalbuminuria from baseline to 12 and 36 months

    Measured: From baseline to 12 and 36 months

  3. Change in CKD stage and CKD prognostic risk

    Change in CKD stage and CKD prognostic risk from baseline to month 12 and 36

    Measured: From baseline to 12 and 36 months

  4. 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

    Measured: From baseline to 12 and 36 months

  5. 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

    Measured: From baseline to 12 and 36 months

  6. 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

    Measured: Time to occurrence (from baseline)

  7. 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

    Measured: At 12 and 36 months after randomization

  8. Change in body weight

    Change in body weight from baseline to months 12 and 36

    Measured: From baseline to 12 and 36 months

  9. Change in body mass index

    Change in body mass index from baseline to months 12 and 36

    Measured: From baseline to 12 and 36 months

  10. Change in waist circumference

    Change in waist circumference from baseline to months 12 and 36

    Measured: From baseline to 12 and 36 months

  11. 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

    Measured: From baseline to 12 and 36 months

  12. Change in fasting glucose

    Change in fasting glucose from baseline to months 12 and 36

    Measured: From baseline to 12 and 36 months

  13. Change in HbA1c

    Change in HbA1c from baseline to months 12 and 36

    Measured: From baseline to 12 and 36 months

  14. Change in basal insulin

    Change in basal insulin from baseline to months 12 and 36

    Measured: From baseline to 12 and 36 months

  15. Change in homeostasis model assessment (HOMA) scores

    Change in homeostasis model assessment (HOMA) scores from baseline to months 12 and 36

    Measured: From baseline to 12 and 36 months

  16. Remission in type 2 diabetes

    Achievement of partial or complete remission in type 2 diabetes by months 12 and 36

    Measured: At 12 and 36 months after randomization

  17. Change in blood pressure

    Change in blood pressure from baseline to months 12 and 36

    Measured: From baseline to 12 and 36 months

  18. Hypoglycemic adverse events

    Number of patients with confirmed or symptomatic hypoglycemic adverse events from baseline to months 12 and 36

    Measured: From baseline to 12 and 36 months

  19. 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

    Measured: From baseline to 12 and 36 months

  20. 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

    Measured: From baseline to 12 and 36 months

  21. Changes in serum calcium and phosphorus,

    Changes in serum calcium and phosphorus from baseline to months 12 and 36

    Measured: From baseline to 12 and 36 months

  22. Change in parathyroid hormone (PTH)

    Change in parathyroid hormone (PTH) from baseline to months 12 and 36

    Measured: From baseline to 12 and 36 months

  23. Change in mineral bone density

    Change in mineral bone density from baseline to months 12 and 36

    Measured: From baseline to 12 and 36 months

  24. Change in quality of life

    Change in quality of life measured by SF-36 questionnaire from baseline to months 12 and 36

    Measured: From baseline to 12 and 36 months

  25. Adverse events

    Number of patients with adverse events from baseline to months 12 and 36

    Measured: From baseline to 12 and 36 months

  26. Acute kidney injury

    Number of episodes of acute kidney injury from baseline to months 12 and 36

    Measured: From baseline to 12 and 36 months

  27. 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

    Measured: From baseline to 12 and 36 months

  28. Mortality

    Total mortality from baseline to months 12 and 36

    Measured: From baseline to 12 and 36 months

  29. Days hospitalized

    Number of days hospitalized from baseline to months 12 and 36

    Measured: From baseline to 12 and 36 months

  30. Change in urinary volume

    Change in urinary volume from baseline to months 12 and 36

    Measured: From baseline to 12 and 36 months

  31. Change in calcium and oxalate excretion

    Change in calcium and oxalate excretion from baseline to months 12 and 36

    Measured: From baseline to 12 and 36 months

  32. High sensitivity c-reactive protein

    Change in high sensitivity c-reactive protein from baseline to months 12 and 36

    Measured: From baseline to 12 and 36 months

  33. Change in muscle strength

    Change in muscle strength using one repetition maximum (1-RM) from baseline to months12 and 36

    Measured: From baseline to 12 and 36 months

  34. Kidney volumes

    Change in kidney volumes from baseline to months 12 and 36

    Measured: From baseline to 12 and 36 months

  35. Change in ventricular mass

    Change in left and right ventricular mass from baseline to months 12 and 36

    Measured: From baseline to 12 and 36 months

  36. Change in ejection fraction

    Change in left ventricular ejection fraction from baseline to months 12 and 36

    Measured: From baseline to 12 and 36 months

  37. Costs of care and health care utilization

    Costs of care and health care utilization from baseline to months 12 and 36

    Measured: From baseline to 12 and 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2020
  2. Study start25 May 2021
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04626323
Sponsor's protocol ID
OBESE-DKD
Other IDs
CAAE - 37013420500000070
Acronym
OBESE-DKD
Status last verified
May 2021
First submitted
4 Nov 2020
Last updated
28 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20150934

  • 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.

    PubMed 11304102

  • 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.

    PubMed 23362314

  • 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.

    PubMed 19954692

  • (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.

    PubMed 28522654

  • 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.

    PubMed 22187472

  • 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.

    PubMed 21602457

  • 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.

    PubMed 11565518

  • 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.

    PubMed 11565517

  • 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.

    PubMed 30990260

  • 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.

    PubMed 21693741

  • 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.

    PubMed 26450931

  • 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.

    PubMed 24356416

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Roux-en-Y gastric bypass and Best medical treatment in people with Diabetes Mellitus, Type 2 and Kidney Disease, Chronic, run by Hospital Alemão Oswaldo Cruz at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Cristina M Aboud, RN, MSc (+551135491187, cmamedio@haoc.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean differenceGlomerular filtration rate (GFR) (time frame: At 12 and 36 months after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04626323, which also lists 61 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in