Weight Loss in Obese Kidney Disease Patients After Bariatric Surgery

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02644928

Enrollment

Registered

2016-01-01

Start date

2016-03-31

Completion date

2019-08-31

Last updated

2019-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate, Chronic Kidney Disease

Keywords

Chronic kidney disease, Bariatric Surgery Candidate, Caloric restriction

Brief summary

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).

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Spain

Outcome results