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).
Full Title of Study: “Effects of Weight Loss on Renal Function in Obese Patients With Chronic Kidney Disease Undergoing Bariatric Surgery”
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: August 2019
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.
Clinical Trial Outcome Measures
- 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.
Participating in This Clinical Trial
- 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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Enrique Morales Ruiz, MD
- Hospital Universitario 12 de Octubre
- Provider of Information About this Clinical Study
- Sponsor-Investigator: Enrique Morales Ruiz, MD, Principal Investigator – Hospital Universitario 12 de Octubre
- Overall Official(s)
- Enrique Morales Ruiz, MD, PhD, Principal Investigator, Hospital Universitario 12 de Octubre
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