Weight Loss in Obese Kidney Disease Patients After Bariatric Surgery

August 13, 2019 updated by: Enrique Morales Ruiz, MD

Effects of Weight Loss on Renal Function in Obese Patients With Chronic Kidney Disease Undergoing 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).

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Obese subjects with renal pathology (decrease in glomerular filtration and/or albuminuria/proteinuria) who are candidates to bariatric surgery.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Enrique Morales Ruiz, MD

Collaborators

Hospital Universitario 12 de Octubre

Investigators

  • Principal Investigator: Enrique Morales Ruiz, MD, PhD, Hospital Universitario 12 de Octubre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

December 23, 2015

First Submitted That Met QC Criteria

December 31, 2015

First Posted (Estimate)

January 1, 2016

Study Record Updates

Last Update Posted (Actual)

August 14, 2019

Last Update Submitted That Met QC Criteria

August 13, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HDOC-BAROBE-2015-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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