Chronic Kidney DiseasesURISTEMNCT04998461
Impact of Obesity, Chronic Kidney Disease and Type 2 Diabetes on Human Urinary Stem Cells
An observational study of Chronic Kidney Diseases and Obesity, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Obesity is at risk for the development of chronic kidney disease but the involved mechanisms are not known (Navarro et al. 2015). Establishing the link between obesity and kidney damage is difficult. Indeed, kidney function measurement lacks precision in obese people (Lemoine et al. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Kidney Diseases, Obesity, Stem Cells
- What is being tested?
- urine collection
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2021to Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: This study will focus on 4 groups of non-diabetic patients, namely: 1. obese patients with preserved renal function 2. obese patients with renal failure 3. non-obese patients with preserved renal function 4. non-obese patients with renal failure (study control group)
Who may be able to join
- Age between 18 and 60
- Non diabetic (fasting blood glucose <1.26 g/L)
- Patient not having objected to participating in the research
- Inclusion Criteria - For the obese group with normal renal function
- eDFG ≥ 60 ml/min/1.73 m2
- BMI > 30 kg/m2
Show all 19Show fewer
- Microalbuminuria / creatinuria ≤ 3mg / mmol and / or proteinuria < 0.15 g/24h
- Inclusion Criteria - For the obese group with impaired renal function
- eDFG < 60 ml/min/1.73 m2
- BMI > 30 kg/m2
- Microalbuminuria / creatinuria ≤ 3mg / mmol and / or proteinuria < 0.15 g/24h
- Inclusion Criteria - For the non-obese group with impaired renal function
- eDFG < 60 ml/min/1.73 m2
- BMI between 18 and 30 kg/m2
- Microalbuminuria / creatinuria ≤ 3mg / mmol and / or proteinuria < 0.15 g/24h
- Inclusion Criteria - For the non-obese group with normal renal function (control group)
- eDFG ≥ 60 ml/min/1.73 m2
- BMI between 18 and 30 kg/m2
- Microalbuminuria / creatinuria ≤ 3mg / mmol and / or proteinuria < 0.15 g/24h
Who cannot join
- Acute renal failure within 3 months (defined as an increase of more than 50% in usual creatinemia)
- Inflammatory, infectious, cardiovascular or progressive neoplastic disease
- Urinary pathology (malformation, infection, etc.)
- Exclusion period of a previous study or already participating in a clinical research protocol having an impact on the judgment criteria of the study
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Lyon SUD
Pierre-Bénite, 69310
Laetitia KOPPE, PhD, 04 72 67 87 15 ext. +33, laetitia.koppe@chu-lyon.fr
About this study
Obesity is at risk for the development of chronic kidney disease but the involved mechanisms are not known (Navarro et al. 2015). Establishing the link between obesity and kidney damage is difficult. Indeed, kidney function measurement lacks precision in obese people (Lemoine et al. 2014) and requires expensive methods such as measurement of 99mTc-DTPA clearance. Biopsies are too invasive for the detection of emerging kidney damage or for the following of the kidney function. Therefore new tools are required for the early identification of at risk individuals for the kidney damage complication.
Mesenchymal stem cells may represent such a relevant tool. These cells are present in a large number of organs, including kidney (Costa et al. 2020).
Read more
In addition to be differentiated cells progenitors (Dominici et al. 2006), they also support immunosuppressive, anti-fibrotic and pro-angiogenic functions that have been used for the treatment of kidney fibrosis (Usunier et al. 2014). Therefore, mesenchymal stem cells contribute to tissue homeostasis and their alterations may reflect organ dysfunctions. Indeed, mesenchymal stem cells from obese adipose tissue lose their immunosuppressive (Serena et al. 2016) and differentiation (Gustafson et al. 2009) functions and contribute to fibrosis (Keophiphath et al. 2009) and inflammation (Lee et al. 2010; Gustafson, Nerstedt, et Smith 2019). It is thus probable that kidney dysfunctions are associated with functional alterations of kidney mesenchymal stem cells.
The collection of mesenchymal stem cells from kidney can easily be performed from urine and next cultivated for amplification. They are called urine stem cells (USC).
From our experience with obese mouse adipose stem cells, we observed that functional changes of stem cells preceded adipose tissue dysfunctions. Functional signatures of mesenchymal stem cells are thus representative of changes occuring in the function of the tissue notably in answer to obesity. These features could be used to identify obese people presenting ongoing alterations of kidney function, before clinical manifestations of kidney dysfunction. Because kidney mesenchymal stem cells are easy to isolate from urine, their collection is compatible with the follow up of patients and can be applied to a large number of individuals, including the younger. USC could represent a valuable tool to detect progression towards kidney damage.
In this project we plan to analyse USC alterations induced by obesity and to identify signatures associated with the progression towards kidney damage and type 2 diabetes. The goal is to evaluate USC as potential marker for the non invasive monitoring of patients in answer to a need that is not achieved by the present available approaches.
- Conditions
- Chronic Kidney Diseases, Obesity, Stem Cells, Diabetes type2
- Being tested
- urine collection
- Keywords
- bio-marker, Chronic Kidney Diseases, Obesity, Diabetes type2
- Medical subject headings
- Renal Insufficiency, Chronic, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urine collectionBiological
To isolate urine stem cells, a sample of 30ml minimum an 100ml maximum as a function of the patient, will be collected in a single time in a sterile flask during collection for the nephrologic exams. A transcriptome analysis of USC will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Obese patients with normal renal function | * estimated Glomerular Filtration Rate (eDFG) ≥ 60 ml/min/1.73 m2
* Body Mass Index (BMI) > 30 kg/m2
* Microalbuminuria / creatinuria ≤ 3mg / mmol and / or proteinuria < 0.15 g/24h Receives: Biological: urine collection | |
| Obese patients with impaired renal function | * estimated Glomerular Filtration Rate (eDFG) < 60 ml/min/1.73 m2
* Body Mass Index (BMI) > 30 kg/m2
* Microalbuminuria / creatinuria ≤ 3mg / mmol and / or proteinuria < 0.15 g/24h Receives: Biological: urine collection | |
| Non-obese patients with impaired renal function | * estimated Glomerular Filtration Rate (eDFG) < 60 ml/min/1.73 m2
* Body Mass Index (BMI) between 18 and 30 kg/m2
* Microalbuminuria / creatinuria ≤ 3mg / mmol and / or proteinuria < 0.15 g/24h Receives: Biological: urine collection | |
| Non-obese patients with normal renal function (control group) | * estimated Glomerular Filtration Rate (eDFG) ≥ 60 ml/min/1.73 m2
* Body Mass Index (BMI) between 18 and 30 kg/m2
* Microalbuminuria / creatinuria ≤ 3mg / mmol and / or proteinuria < 0.15 g/24h Receives: Biological: urine collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of gene expression in USC (Urinary Stem Cells)
High throughput sequencing will be used to compare USC (Urinary Stem Cells) for the differential expression of genes between the 4 populations (obese or lean patients, with or without alteration of the kidney function). A gene set enrichment analysis will be used to identify the main functions supported by USC from each patient, establishing a signature.
Measured: inclusion day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study startNov 2021 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laetitia KOPPE, PhD, Principal investigator, Service de néphrologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998461
- Sponsor's protocol ID
- 69HCL21_0907
- Other IDs
- 2021-A02135-36
- Acronym
- URISTEM
- Status last verified
- Aug 2021
- First submitted
- 2 Aug 2021
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Obesity, Chronic Kidney Disease and Type 2 Diabetes on Human Urinary Stem Cells
- ClinicalTrials.gov ID
- NCT04998461
- Acronym / sponsor ID
- URISTEM / 69HCL21_0907
- Conditions
- Chronic Kidney Diseases, Obesity, Stem Cells, Diabetes type2
- Keywords
- bio-marker, Chronic Kidney Diseases, Obesity, Diabetes type2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity is at risk for the development of chronic kidney disease but the involved mechanisms are not known (Navarro et al. 2015). Establishing the link between obesity and kidney damage is difficult. Indeed, kidney function measurement lacks precision in obese people (Lemoine et al. 2014) and requires expensive methods such as measurement of 99mTc-DTPA clearance. Biopsies are too invasive for the detection of emerging kidney damage or for the following of the kidney function. Therefore new tools are required for the early identification of at risk individuals for the kidney damage complication.
Mesenchymal stem cells may represent such a relevant tool. These cells are present in a large number of organs, including kidney (Costa et al. 2020).
In addition to be differentiated cells progenitors (Dominici et al. 2006), they also support immunosuppressive, anti-fibrotic and pro-angiogenic functions that have been used for the treatment of kidney fibrosis (Usunier et al. 2014). Therefore, mesenchymal stem cells contribute to tissue homeostasis and their alterations may reflect organ dysfunctions. Indeed, mesenchymal stem cells from obese adipose tissue lose their immunosuppressive (Serena et al. 2016) and differentiation (Gustafson et al. 2009) functions and contribute to fibrosis (Keophiphath et al. 2009) and inflammation (Lee et al. 2010; Gustafson, Nerstedt, et Smith 2019). It is thus probable that kidney dysfunctions are associated with functional alterations of kidney mesenchymal stem cells.
The collection of mesenchymal stem cells from kidney can easily be performed from urine and next cultivated for amplification. They are called urine stem cells (USC).
From our experience with obese mouse adipose stem cells, we observed that functional changes of stem cells preceded adipose tissue dysfunctions. Functional signatures of mesenchymal stem cells are thus representative of changes occuring in the function of the tissue notably in answer to obesity. These features could be used to identify obese people presenting ongoing alterations of kidney function, before clinical manifestations of kidney dysfunction. Because kidney mesenchymal stem cells are easy to isolate from urine, their collection is compatible with the follow up of patients and can be applied to a large number of individuals, including the younger. USC could represent a valuable tool to detect progression towards kidney damage.
In this project we plan to analyse USC alterations induced by obesity and to identify signatures associated with the progression towards kidney damage and type 2 diabetes. The goal is to evaluate USC as potential marker for the non invasive monitoring of patients in answer to a need that is not achieved by the present available approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Obese patients with normal renal function | – | Biological: urine collection* estimated Glomerular Filtration Rate (eDFG) ≥ 60 ml/min/1.73 m2 * Body Mass Index (BMI) > 30 kg/m2 * Microalbuminuria / creatinuria ≤ 3mg / mmol and / or proteinuria < 0.15 g/24h |
| Obese patients with impaired renal function | – | Biological: urine collection* estimated Glomerular Filtration Rate (eDFG) < 60 ml/min/1.73 m2 * Body Mass Index (BMI) > 30 kg/m2 * Microalbuminuria / creatinuria ≤ 3mg / mmol and / or proteinuria < 0.15 g/24h |
| Non-obese patients with impaired renal function | – | Biological: urine collection* estimated Glomerular Filtration Rate (eDFG) < 60 ml/min/1.73 m2 * Body Mass Index (BMI) between 18 and 30 kg/m2 * Microalbuminuria / creatinuria ≤ 3mg / mmol and / or proteinuria < 0.15 g/24h |
| Non-obese patients with normal renal function (control group) | – | Biological: urine collection* estimated Glomerular Filtration Rate (eDFG) ≥ 60 ml/min/1.73 m2 * Body Mass Index (BMI) between 18 and 30 kg/m2 * Microalbuminuria / creatinuria ≤ 3mg / mmol and / or proteinuria < 0.15 g/24h |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study will focus on 4 groups of non-diabetic patients, namely: 1. obese patients with preserved renal function 2. obese patients with renal failure 3. non-obese patients with preserved renal function 4. non-obese patients with renal failure (study control group)
Key inclusion criteria (19 listed)
- Age between 18 and 60
- Non diabetic (fasting blood glucose <1.26 g/L)
- Patient not having objected to participating in the research
- Inclusion Criteria - For the obese group with normal renal function
- eDFG ≥ 60 ml/min/1.73 m2
Key exclusion criteria (4 listed)
- Acute renal failure within 3 months (defined as an increase of more than 50% in usual creatinemia)
- Inflammatory, infectious, cardiovascular or progressive neoplastic disease
- Urinary pathology (malformation, infection, etc.)
- Exclusion period of a previous study or already participating in a clinical research protocol having an impact on the judgment criteria of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urine collectionTo isolate urine stem cells, a sample of 30ml minimum an 100ml maximum as a function of the patient, will be collected in a single time in a sterile flask during collection for the nephrologic exams. A transcriptome analysis of USC will be performed. | Biological | Non-obese patients with impaired renal function, Non-obese patients with normal renal function (control group), Obese patients with impaired renal function, Obese patients with normal renal function |
Primary outcome
Comparison of gene expression in USC (Urinary Stem Cells)
Time frame: inclusion day
High throughput sequencing will be used to compare USC (Urinary Stem Cells) for the differential expression of genes between the 4 populations (obese or lean patients, with or without alteration of the kidney function). A gene set enrichment analysis will be used to identify the main functions supported by USC from each patient, establishing a signature.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laetitia KOPPE, PhD principal investigator
Service de néphrologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Obesity, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laetitia KOPPE, PhD (04 72 67 87 15 ext. +33, laetitia.koppe@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of gene expression in USC (Urinary Stem Cells) (time frame: inclusion day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.