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Completed

NCT Number: NCT02644928

Weight Loss in Obese Kidney Disease Patients After Bariatric Surgery

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-70 years (male or female).
  • BMI >35 kg/m2 who meet the following criteria:
  • GFR 30-60 ml/min and proteinuria>1g/24 hours despite receiving maximally tolerated doses of blocking the renin-angiotensin system.
  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Enrique Morales Ruiz, MD

Other

Collaborators

  • Hospital Universitario 12 de Octubre

Registry information

Official study title

Effects of Weight Loss on Renal Function in Obese Patients With Chronic Kidney Disease Undergoing Bariatric Surgery

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 1, 2016
Registry last updated
Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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