Weight Loss in Obese Kidney Disease Patients After Bariatric Surgery

NCT ID: NCT02644928

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2019-08-31

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.

Conditions

Chronic Kidney Disease; Bariatric Surgery Candidate

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario 12 de Octubre

OTHER

Sponsor Role: collaborator

Enrique Morales Ruiz, MD

OTHER

Sponsor Role: lead

Responsible Party

Enrique Morales Ruiz, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Enrique Morales Ruiz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario 12 de Octubre

Locations

Hospital Universitario 12 de Octubre

Madrid, , Spain

Countries

Spain

Other Identifiers

HDOC-BAROBE-2015-01

Identifier Type: -

Identifier Source: org_study_id