Early Diagnosis of Kidney Damage Associated With Tobacco Use

NCT03850756 | Completed

• 1 other identifier: BIOTAB
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 2

Brief Summary

Tobacco consumption is associated with the appearance of several pathologies, the best known are Chronic Obstructive Pulmonary Disease, several types of cancer and cardiovascular diseases. However, the association between tobacco and kidney damage is not well defined. Some studies suggest that smoking favors progression to chronic kidney disease (CKD). CKD does not have pharmacological treatment and the only clinical strategies useful so far are dialysis or kidney transplantation. Therefore, knowing if tobacco is involved in this disease is a very relevant fact, since it is a modifiable factor. Of all the risk factors associated with the onset and progression of kidney disease is the only one that can be avoid or eliminated. Therefore quitting smoking could help reduce the incidence of this pathology. In this project, 3 main objectives were proposed:

1. 1.First: to study the tobacco-CKD association in a more exhaustive way. In a population group (patients who attend a primary care center) the renal function of smokers will be evaluated, comparing it with that of non-smokers with similar characteristics (age, sex, etc). In addition, the presence of certain pathologies that can affect the kidney (diabetes mellitus, hypertension and / or frequent consumption of certain medications) will be taken into account. To evaluate the renal functionality, the markers commonly used in the clinic and other more novel ones will be used (urinary biomarkers of early kidney damage).
2. 2.Second: to assess whether smoking patients will be more likely to suffer kidney damage in the future. This will be done by monitoring the patients mentioned above, for two years. During this time, a group of novel markers (urinary biomarkers of predisposition to kidney damage) that in previous studies have detected susceptibility to kidney damage will be evaluated. It will be determined which one or more of these markers are capable of predicting at time 0 (when the first sample of the patient is taken) the subsequent appearance of renal damage.
3. 3.Third: to study whether stopping smoking reduces the risk of developing CKD. It will be evaluated whether stopping smoking reduces the susceptibility to kidney damage by using the biomarkers mentioned above.

Conditions

Kidney Injury; Kidney Disease, Chronic; Tobacco Toxicity

Keywords

Biomarker; Tobacco; Nephrotoxicity; Prevention; Diagnosis

Outcome Measures

Primary Outcomes (6)

• Change of urinary albumin

  It is a biomarker of early kidney damage. It is able to detect kidney damage in the early stages, before the clinical markers creatinine and plasma urea. There are no reference values for humans, so the means of non-smoking patients without risk factors (group 1) should be compared with the rest of the groups. This biomarker will be measured at different times to evaluate its evolution and compare it against the baseline value.

  For objectives 1 and 2 (2 years): 0 and 24 months. For the objective 3 (1 year): 0, 3, 6 and 12 months

• Change of urinary N-Acetyl-β-D-Glucosaminidase (NAG)

  It is an enzyme whose urinary excretion is elevated in case of kidney damage. It is capable of detecting damage before the classic plasma creatinin and urea markers. There are no reference values for humans, so the means of non-smoking patients without risk factors (group 1) should be compared with the rest of the groups. This biomarker will be measured at different times to evaluate its evolution and compare it against the baseline value.

  For objectives 1 and 2 (2 years): 0 and 24 months. For the objective 3 (1 year): 0, 3, 6 and 12 months

• Change of urinary Kidney Injury Molecule-1 (KIM-1)

  It is a biomarker of early kidney damage. It is able to detect kidney damage in the early stages, before the clinical markers creatinine and plasma urea. There are no reference values for humans, so the means of non-smoking patients without risk factors (group 1) should be compared with the rest of the groups. This biomarker will be measured at different times to evaluate its evolution and compare it against the baseline value.

  For objectives 1 and 2 (2 years): 0 and 24 months. For the objective 3 (1 year): 0, 3, 6 and 12 months

• Change of urinary Neutrophil gelatinase-associated lipocalin (NGAL)

  It is a biomarker of early kidney damage. It is able to detect kidney damage in the early stages, before the clinical markers creatinine and plasma urea. There are no reference values for humans, so the means of non-smoking patients without risk factors (group 1) should be compared with the rest of the groups. This biomarker will be measured at different times to evaluate its evolution and compare it against the baseline value.

  For objectives 1 and 2 (2 years): 0 and 24 months. For the objective 3 (1 year): 0, 3, 6 and 12 months

• Change of urinary T-gelsolin.

  It is a biomarker of early kidney damage. It is able to detect kidney damage in the early stages, before the clinical markers creatinine and plasma urea. There are no reference values for humans, so the means of non-smoking patients without risk factors (group 1) should be compared with the rest of the groups.This biomarker will be measured at different times to evaluate its evolution and compare it against the baseline value.

  For objectives 1 and 2 (2 years): 0 and 24 months. For the objective 3 (1 year): 0, 3, 6 and 12 months

• Change of urinary biomarkers of predisposition to kidney injury

  It is a group of markers that are in patent phase so their names can not be mentioned. They are able to detect the susceptibility to kidney damage before administering a nephrotoxic agent. There are no reference values for humans, so the means of non-smoking patients without risk factors (group 1) should be compared with the rest of the groups. This biomarker will be measured at different times to evaluate its evolution and compare it against the baseline value.

  For objectives 1 and 2 (2 years): 0 and 24 months. For the objective 3 (1 year): 0, 3, 6 and 12 months

Secondary Outcomes (10)

• Percentage of patients with Risk factor's

  These data will be collected once, at time 0 (moment of inclusion in the study)

• Body weight

  These data will be collected once, at time 0 (moment of inclusion in the study)

• Height

  These data will be collected once, at time 0 (moment of inclusion in the study)

• Body mass index (BMI)

  These data will be collected once, at time 0 (moment of inclusion in the study)

• Age

  These data will be collected once, at time 0 (moment of inclusion in the study)

Study Arms (4)

1: No smokers without risk factors

A smoker is defined as: any person who habitually consumes tobacco at the time of taking the sample or who has left it in the last 12 months (WHO, 2008). The following circumstances involved in the development of kidney damage will be considered a risk factor: Diabetes Mellitus, Hypertension and / or frequent use of NSAIDs (more than three days a week during the three months prior to sampling) In these patients kidney function will be evaluated by: Early kidney damage biomarkers Predisposition to kidney injury biomarkers

Diagnostic Test: Early kidney damage biomarkers; Diagnostic Test: Predisposition to kidney injury biomarkers

2: No smokers with risk factors

A smoker is defined as: any person who habitually consumes tobacco at the time of taking the sample or who has left it in the last 12 months (WHO, 2008). The following circumstances involved in the development of kidney damage will be considered a risk factor: Diabetes Mellitus, Hypertension and / or frequent use of NSAIDs (more than three days a week during the three months prior to sampling) In these patients kidney function will be evaluated by: Early kidney damage biomarkers

Diagnostic Test: Early kidney damage biomarkers

3: Smokers without risk factors

A smoker is defined as: any person who habitually consumes tobacco at the time of taking the sample or who has left it in the last 12 months (WHO, 2008). The following circumstances involved in the development of kidney damage will be considered a risk factor: Diabetes Mellitus, Hypertension and / or frequent use of NSAIDs (more than three days a week during the three months prior to sampling) In these patients kidney function will be evaluated by: Early kidney damage biomarkers Predisposition to kidney injury biomarkers Also tobacco consumption will be measured

Diagnostic Test: Early kidney damage biomarkers; Diagnostic Test: Predisposition to kidney injury biomarkers; Diagnostic Test: Tobacco consumption

4: Smokers without risk factors

A smoker is defined as: any person who habitually consumes tobacco at the time of taking the sample or who has left it in the last 12 months (WHO, 2008). The following circumstances involved in the development of kidney damage will be considered a risk factor: Diabetes Mellitus, Hypertension and / or frequent use of NSAIDs (more than three days a week during the three months prior to sampling) In these patients kidney function will be evaluated by: Early kidney damage biomarkers Also Tobacco consumption will be measured

Diagnostic Test: Early kidney damage biomarkers; Diagnostic Test: Tobacco consumption

Interventions

Early kidney damage biomarkers DIAGNOSTIC_TEST

In the urine samples of these patients, a series of biomarkers of early kidney damage and / or predisposition to kidney damage will be measured.

Also known as: albumin, N-acetyl-beta-D-glucosaminidase (NAG), Kidney Injury Molecule-1 (KIM-1), Neutrophil gelatinase-associated lipocalin (NGAL), T-gelsolin

1: No smokers without risk factors; 2: No smokers with risk factors; 3: Smokers without risk factors; 4: Smokers without risk factors

Predisposition to kidney injury biomarkers DIAGNOSTIC_TEST

In the urine samples of these patients, a series of biomarkers of predisposition to kidney damage will be measured.

1: No smokers without risk factors; 3: Smokers without risk factors

Tobacco consumption DIAGNOSTIC_TEST

In order to know the degree of tobacco consumption, the biomarker cotinine will be measured in the urine samples of these patients.

3: Smokers without risk factors; 4: Smokers without risk factors

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will be carried out with the general population, specifically patients who attend a Primary Care consultation (Objectives 1 and 2), and people who come to the Smoking Unit to try to stop smoking (Objective 3)

You may not qualify if:

• Patients who are terminally ill; presenting previously diagnosed renal failure
• Patients that during the week prior to the sample collection, or at the time of the sample, have been treated with any of the following drugs: aminoglycosides, cephalosporins, tetracyclines, amphotericin B, cisplatin, cyclosporine, foscarnet, acyclovir, cidofovir, radiological contrasts or any other potentially nephrotoxic drug.
• Patients who do not wish to sign the informed consent

Sponsors & Collaborators

• Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León: lead
• Instituto de Investigación Biomédica de Salamanca: collaborator
• Grupo de Investigación de Atención Primaria de Castilla y León: collaborator
• Salamanca University Hospital: collaborator
• Instituto de Salud Carlos III: collaborator

Study Sites (2)

Centro de Salud La Alamedilla

Salamanca, Spain

Location

Unidad de tabaquismo del CAUSA

Salamanca, Spain

Location

Related Publications (2)

• Prieto M, Vicente-Vicente L, Casanova AG, Hernandez-Sanchez MT, Gomez-Marcos MA, Garcia-Ortiz L, Morales AI; members of the Biomarkers of kidney damage and tobacco. Designing new diagnostic systems for the early detection of tobacco-associated chronic renal damage in patients of a primary care centre in Salamanca, Spain: an observational, prospective study protocol. BMJ Open. 2020 Mar 8;10(3):e032918. doi: 10.1136/bmjopen-2019-032918.

  PMID: 32152160 BACKGROUND

• Tascon J, Prieto M, Casanova AG, Sanz FJ, Hernandez Mezquita MA, Barrueco Ferrero M, Gomez-Marcos MA, Garcia-Ortiz L, Vicente-Vicente L, Morales AI, On Behalf Of Biotab Team. Early Diagnosis of Kidney Damage Associated with Tobacco Use: Preventive Application. J Pers Med. 2022 Jun 24;12(7):1032. doi: 10.3390/jpm12071032.

  PMID: 35887529 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

In this project, only urine samples will be collected. This will be centrifuged, aliquoted and stored at -80 degrees Celsius until its determination.

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Disease

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

• Ana Isabel Morales Martín, PhD

  University of Salamanca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: February 22, 2019
• Study Start: March 4, 2019
• Primary Completion: April 1, 2022
• Study Completion: July 1, 2022
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)