Weight Loss in Obese Kidney Disease Patients After Bariatric Surgery

Overview

This study is designed as a prospective, single-center, longitudinal and analytical study on the effect of bariatric surgery in obese patients with chronic kidney disease (CKD).

Full Title of Study: “Effects of Weight Loss on Renal Function in Obese Patients With Chronic Kidney Disease Undergoing Bariatric Surgery”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2019

Detailed Description

It is expected to enroll 22 obese subjects with chronic kidney disease (decrease in glomerular filtration and/or albuminuria/proteinuria). After the inclusion in the study patients will remain for six months with a reduced calorie diet until the day of bariatric surgery. Time monitoring of the patient after surgery is 24 months.

Clinical Trial Outcome Measures

Primary Measures

  • Reduction of proteinuria/albuminuria in patients with obesity and nephropathy of any etiology treated with bariatric surgery
    • Time Frame: 24 months
    • Reduction (measured as a percentage) of proteinuria/albuminuria in patients with obesity after bariatric surgery.

Participating in This Clinical Trial

Inclusion Criteria

  • Age 18-70 years (male or female). – BMI >35 kg/m2 who meet the following criteria: 1. GFR 30-60 ml/min and proteinuria>1g/24 hours despite receiving maximally tolerated doses of blocking the renin-angiotensin system. 2. GFR >60 ml/min and proteinuria >(3.5) 2.5 g/24 hours despite receiving maximally tolerated doses of blocking the renin-angiotensin system. – Patients with BMI> 40 kg/m2 with a GFR> 30 ml/min and proteinuria >(1) 0.5 g/24 hours despite receiving maximally tolerated doses of blocking the renin-angiotensin system. – Patients who are able to understand the purpose and risks of the study, which has been fully informed and have finally given the written informed consent according to the ICH-GCP. Patients who can not read or write but who properly understand the verbal information provided by the investigator (or sub-investigator) the consent will be granted orally before their inclusion and an independent witness will signing the informed consent document. Exclusion Criteria:

  • Subjects who are participating or have participated in another clinical trial and/or who are taking or have taken an experimental drug (not registered) in the last 28 days. – Patients with chronic renal replacement therapy (hemodialysis and/or peritoneal dialysis) and/or renal transplantation. – Patients with poorly controlled blood pressure (SBP> 170 mmHg or DBP> 110 mmHg). – Patients with a history of cardiovascular events (stroke, ischemic heart disease) in the past six months. – Patients treated with steroids or other immunosuppressants. – Patients with a history of renovascular disease, obstructive uropathy, autoimmune diseases, cancer, drug use. – Patients who are pregnant or lactating. – Patients who do not sign the informed consent. – A slight chance of compliance with visits scheduled in the protocol.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Enrique Morales Ruiz, MD
  • Collaborator
    • Hospital Universitario 12 de Octubre
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Enrique Morales Ruiz, MD, Principal Investigator – Hospital Universitario 12 de Octubre
  • Overall Official(s)
    • Enrique Morales Ruiz, MD, PhD, Principal Investigator, Hospital Universitario 12 de Octubre

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