Weight Loss in Obese Kidney Disease Patients After Bariatric Surgery

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02644928
• Other study ID #: HDOC-BAROBE-2015-01
• Status: Completed
• Start date: March 2016
• Est. completion date: August 2019

Study information

• Verified date: August 2019
• Source: Hospital Universitario 12 de Octubre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic
• Weight Loss

Locations

Country	Name	City	State
Spain	Hospital Universitario 12 de Octubre	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Enrique Morales Ruiz, MD	Hospital Universitario 12 de Octubre

Country where clinical trial is conducted

Spain, 

Outcome

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