Clinical trial NCT02644928: Weight Loss in Obese Kidney Disease Patients After Bariatric Surgery
Official title: Effects of Weight Loss on Renal Function in Obese Patients With Chronic Kidney Disease Undergoing Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Bariatric Surgery Candidate
Keywords: Chronic kidney disease
Bariatric Surgery Candidate
Caloric restriction
Lead sponsor: Hospital Universitario 12 de Octubre
Sponsor class: OTHER
Collaborators: name: Hospital Universitario 12 de Octubre
First posted: 2016-01-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reduction of proteinuria/albuminuria in patients with obesity and nephropathy of any etiology treated with bariatric surgery
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
affiliation: Hospital Universitario 12 de Octubre
name: Enrique Morales Ruiz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: