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Randomized Study Comparing Metabolic Surgery With Intensive Medical Therapy to Treat Diabetic Kidney Disease (OBESE-DKD)

Primary Purpose

Diabetes Mellitus, Type 2, Kidney Disease, Chronic, Kidney Injury

Status
Recruiting
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Roux-en-Y gastric bypass
Best medical treatment
Sponsored by
Hospital Alemão Oswaldo Cruz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Type 2, Diabetes Mellitus, Obesity, Metabolic surgery, Gastric bypass, Diabetic kidney disease

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 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:

  • 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
  • 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RYGB (intervention arm)

BMT (control arm).

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in twenty-four hour urinary albumin/protein excretion
Change in 24h urinary albumin/protein excretion
Improvements in micro- or macroalbuminuria
Proportion of patients who achieve improvements in micro- or macroalbuminuria 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
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
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
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
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
Change in body weight
Change in body weight from baseline to months 12 and 36
Change in body mass index
Change in body mass index from baseline to months 12 and 36
Change in waist circumference
Change in waist circumference from baseline to months 12 and 36
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
Change in fasting glucose
Change in fasting glucose from baseline to months 12 and 36
Change in HbA1c
Change in HbA1c from baseline to months 12 and 36
Change in basal insulin
Change in basal insulin from baseline to months 12 and 36
Change in homeostasis model assessment (HOMA) scores
Change in homeostasis model assessment (HOMA) scores from baseline to months 12 and 36
Remission in type 2 diabetes
Achievement of partial or complete remission in type 2 diabetes by months 12 and 36
Change in blood pressure
Change in blood pressure from baseline to months 12 and 36
Hypoglycemic adverse events
Number of patients with confirmed or symptomatic hypoglycemic adverse events from baseline to months 12 and 36
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
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
Changes in serum calcium and phosphorus,
Changes in serum calcium and phosphorus from baseline to months 12 and 36
Change in parathyroid hormone (PTH)
Change in parathyroid hormone (PTH) from baseline to months 12 and 36
Change in mineral bone density
Change in mineral bone density from baseline to months 12 and 36
Change in quality of life
Change in quality of life measured by SF-36 questionnaire from baseline to months 12 and 36
Adverse events
Number of patients with adverse events from baseline to months 12 and 36
Acute kidney injury
Number of episodes of acute kidney injury from baseline to months 12 and 36
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
Mortality
Total mortality from baseline to months 12 and 36
Days hospitalized
Number of days hospitalized from baseline to months 12 and 36
Change in urinary volume
Change in urinary volume from baseline to months 12 and 36
Change in calcium and oxalate excretion
Change in calcium and oxalate excretion from baseline to months 12 and 36
High sensitivity c-reactive protein
Change in high sensitivity c-reactive protein from baseline to months 12 and 36
Change in muscle strength
Change in muscle strength using one repetition maximum (1-RM) from baseline to months12 and 36
Kidney volumes
Change in kidney volumes from baseline to months 12 and 36
Change in ventricular mass
Change in left and right ventricular mass from baseline to months 12 and 36
Change in ejection fraction
Change in left ventricular ejection fraction from baseline to months 12 and 36
Costs of care and health care utilization
Costs of care and health care utilization from baseline to months 12 and 36

Full Information

First Posted
November 4, 2020
Last Updated
May 27, 2021
Sponsor
Hospital Alemão Oswaldo Cruz
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1. Study Identification

Unique Protocol Identification Number
NCT04626323
Brief Title
Randomized Study Comparing Metabolic Surgery With Intensive Medical Therapy to Treat Diabetic Kidney Disease
Acronym
OBESE-DKD
Official Title
Open, Randomized, Unicenter Study Comparing Metabolic Surgery With Intensive Medical Therapy to Treat Diabetic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Alemão Oswaldo Cruz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Kidney Disease, Chronic, Kidney Injury
Keywords
Diabetes Mellitus, Type 2, Diabetes Mellitus, Obesity, Metabolic surgery, Gastric bypass, Diabetic kidney disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RYGB (intervention arm)
Arm Type
Experimental
Arm Description
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.
Arm Title
BMT (control arm).
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Roux-en-Y gastric bypass
Other Intervention Name(s)
RYGB
Intervention Description
Pneumoperitoneum closed with Veress needle Identification of Treitz angle Measurement of biliary loop (50 cm) Bowel transection with linear stapler (white load) Measurement of the alimentary limb (100 cm) Laterolateral Entero-anastomoses (white load) Construction of gastric pouch distant about 3 cm from the esophageal-gastric junction with stomach section in the small curvature. Linear cutting anastomosis (gastrojejunostomy) from about 1 to 1.2 cm Anastomosis integrity evaluation by methylene blue test and/or perioperative air. Expected surgical time: 60 minutes
Intervention Type
Drug
Intervention Name(s)
Best medical treatment
Other Intervention Name(s)
BMT
Intervention Description
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).
Primary Outcome Measure Information:
Title
Mean differenceGlomerular filtration rate (GFR)
Description
Mean difference in GFR between BMT and RYGB at the pre-specified time points of 12 and 36 months after randomization
Time Frame
At 12 and 36 months after randomization
Secondary Outcome Measure Information:
Title
Change in twenty-four hour urinary albumin/protein excretion
Description
Change in 24h urinary albumin/protein excretion
Time Frame
From baseline to 12 and 36 months
Title
Improvements in micro- or macroalbuminuria
Description
Proportion of patients who achieve improvements in micro- or macroalbuminuria from baseline to 12 and 36 months
Time Frame
From baseline to 12 and 36 months
Title
Change in CKD stage and CKD prognostic risk
Description
Change in CKD stage and CKD prognostic risk from baseline to month 12 and 36
Time Frame
From baseline to 12 and 36 months
Title
Change in GFR, eGFR and 24 hr creatinine clearance
Description
Change in GFR, eGFR and 24 hr creatinine clearance from baseline to months 12 and 36
Time Frame
From baseline to 12 and 36 months
Title
Proportion of participants with ≥30%, ≥40%, and ≥50% reduction in GFR measurements
Description
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
Time Frame
From baseline to 12 and 36 months
Title
Decline in eGFR, sustained low eGFR, kidney transplantation, maintenance dialysis, and kidney death
Description
Time to occurrence of sustained % decline in eGFR, sustained low eGFR, kidney transplantation, maintenance dialysis, and kidney death
Time Frame
Time to occurrence (from baseline)
Title
Maintenance dialysis, kidney transplantation, kidney death, and GFR < 15 ml/min
Description
Individual and composite endpoints of maintenance dialysis, kidney transplantation, kidney death, and GFR < 15 ml/min at 12 and 36 months
Time Frame
At 12 and 36 months after randomization
Title
Change in body weight
Description
Change in body weight from baseline to months 12 and 36
Time Frame
From baseline to 12 and 36 months
Title
Change in body mass index
Description
Change in body mass index from baseline to months 12 and 36
Time Frame
From baseline to 12 and 36 months
Title
Change in waist circumference
Description
Change in waist circumference from baseline to months 12 and 36
Time Frame
From baseline to 12 and 36 months
Title
Medications to maintain optimal diabetes and blood pressure control
Description
Number and dose of medications to maintain optimal diabetes and blood pressure control from baseline to months 12 and 36
Time Frame
From baseline to 12 and 36 months
Title
Change in fasting glucose
Description
Change in fasting glucose from baseline to months 12 and 36
Time Frame
From baseline to 12 and 36 months
Title
Change in HbA1c
Description
Change in HbA1c from baseline to months 12 and 36
Time Frame
From baseline to 12 and 36 months
Title
Change in basal insulin
Description
Change in basal insulin from baseline to months 12 and 36
Time Frame
From baseline to 12 and 36 months
Title
Change in homeostasis model assessment (HOMA) scores
Description
Change in homeostasis model assessment (HOMA) scores from baseline to months 12 and 36
Time Frame
From baseline to 12 and 36 months
Title
Remission in type 2 diabetes
Description
Achievement of partial or complete remission in type 2 diabetes by months 12 and 36
Time Frame
At 12 and 36 months after randomization
Title
Change in blood pressure
Description
Change in blood pressure from baseline to months 12 and 36
Time Frame
From baseline to 12 and 36 months
Title
Hypoglycemic adverse events
Description
Number of patients with confirmed or symptomatic hypoglycemic adverse events from baseline to months 12 and 36
Time Frame
From baseline to 12 and 36 months
Title
Changes in total cholesterol, triglycerides, LDL and HDL levels
Description
Changes in total cholesterol, triglycerides, LDL and HDL levels from baseline to months 12 and 36
Time Frame
From baseline to 12 and 36 months
Title
Number of participants achieving LDL < 100 mg/dL and HDL > 40mg/dL
Description
Number of participants achieving LDL < 100 mg/dL and HDL > 40mg/dL from baseline to months 12 and 36
Time Frame
From baseline to 12 and 36 months
Title
Changes in serum calcium and phosphorus,
Description
Changes in serum calcium and phosphorus from baseline to months 12 and 36
Time Frame
From baseline to 12 and 36 months
Title
Change in parathyroid hormone (PTH)
Description
Change in parathyroid hormone (PTH) from baseline to months 12 and 36
Time Frame
From baseline to 12 and 36 months
Title
Change in mineral bone density
Description
Change in mineral bone density from baseline to months 12 and 36
Time Frame
From baseline to 12 and 36 months
Title
Change in quality of life
Description
Change in quality of life measured by SF-36 questionnaire from baseline to months 12 and 36
Time Frame
From baseline to 12 and 36 months
Title
Adverse events
Description
Number of patients with adverse events from baseline to months 12 and 36
Time Frame
From baseline to 12 and 36 months
Title
Acute kidney injury
Description
Number of episodes of acute kidney injury from baseline to months 12 and 36
Time Frame
From baseline to 12 and 36 months
Title
Adverse cardiovascular events (nonfatal stroke, nonfatal MI, cardiovascular death)
Description
Composite of major adverse cardiovascular events (nonfatal stroke, nonfatal MI, cardiovascular death) from baseline to months 12 and 36
Time Frame
From baseline to 12 and 36 months
Title
Mortality
Description
Total mortality from baseline to months 12 and 36
Time Frame
From baseline to 12 and 36 months
Title
Days hospitalized
Description
Number of days hospitalized from baseline to months 12 and 36
Time Frame
From baseline to 12 and 36 months
Title
Change in urinary volume
Description
Change in urinary volume from baseline to months 12 and 36
Time Frame
From baseline to 12 and 36 months
Title
Change in calcium and oxalate excretion
Description
Change in calcium and oxalate excretion from baseline to months 12 and 36
Time Frame
From baseline to 12 and 36 months
Title
High sensitivity c-reactive protein
Description
Change in high sensitivity c-reactive protein from baseline to months 12 and 36
Time Frame
From baseline to 12 and 36 months
Title
Change in muscle strength
Description
Change in muscle strength using one repetition maximum (1-RM) from baseline to months12 and 36
Time Frame
From baseline to 12 and 36 months
Title
Kidney volumes
Description
Change in kidney volumes from baseline to months 12 and 36
Time Frame
From baseline to 12 and 36 months
Title
Change in ventricular mass
Description
Change in left and right ventricular mass from baseline to months 12 and 36
Time Frame
From baseline to 12 and 36 months
Title
Change in ejection fraction
Description
Change in left ventricular ejection fraction from baseline to months 12 and 36
Time Frame
From baseline to 12 and 36 months
Title
Costs of care and health care utilization
Description
Costs of care and health care utilization from baseline to months 12 and 36
Time Frame
From baseline to 12 and 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cristina M Aboud, RN, MSc
Phone
+551135491187
Email
cmamedio@haoc.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo V Cohen, MD, PhD
Organizational Affiliation
Oswaldo Cruz German Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro especializado em Obesidade e Diabetes do Hospital Alemão Oswaldo Cruz
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01323-020
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina M Aboud, RN, MSc
Phone
1135491187
Email
cmamedio@haoc.com.br

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
https://centrodeobesidadeediabetes.org.br/
Description
Obesity and Diabetes Center
URL
https://www.hospitaloswaldocruz.org.br/
Description
Oswaldo Cruz German Hospital

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

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