Weight Loss in Obese Kidney Disease Patients After Bariatric Surgery

NCT02644928 | Completed

• 1 other identifier: HDOC-BAROBE-2015-01
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Kidney Disease; Bariatric Surgery Candidate

Keywords

Chronic kidney disease; Bariatric Surgery Candidate; Caloric restriction

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age 18-70 years (male or female).
• BMI \>35 kg/m2 who meet the following criteria:
• GFR 30-60 ml/min and proteinuria\>1g/24 hours despite receiving maximally tolerated doses of blocking the renin-angiotensin system.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Enrique Morales Ruiz, MD: lead
• Hospital Universitario 12 de Octubre: collaborator

Study Sites (1)

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

In this study, blood and urine samples will be collected to determine the effect of weight loss in proteinuria and renal function.

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Enrique Morales Ruiz, MD, PhD

  Hospital Universitario 12 de Octubre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 23, 2015
• First Posted: January 1, 2016
• Study Start: March 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: August 14, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)