Diabetic Kidney DiseaseNCT04176276
Determining Serum and Urinary Levels of miRNA 192 and miRNA 25 in Patients With and Without Type 2 Diabetes.
An observational study of Diabetic Kidney Disease and Type2 Diabetes, run by University of Pisa at 1 site in Italy.
Trial summary
Diabetes kidney disease (DKD) is the leading cause of end stage renal disease (ESRD) in western countries and its incidence is worryingly increasing worldwide. Cardiovascular disease shows a continuous relationship with declining of renal function in type 2 diabetes patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Kidney Disease, Type2 Diabetes
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2018to 1 Mar 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will consecutively enrolled 300 patients (200 patients with type 2 diabetes and 100 patients without diabetes) among those referring to the Departiment of Diabetes and Metabolic disease, Santa Chiara Hospital, Pisa.
Who may be able to join
- age ≥ 18 years and ≤ 75 years
- male or female patients with type 2 diabetes treated with life style modification only or any OAD or insulin
- BMI ≥ 20 e ≤ 40 Kg/m2
- patients able to consent
- age ≥ 18 years and ≤ 75 years
- BMI ≥ 20 e ≤ 40 Kg/m2
- patients able to consent
Who cannot join
- personal history of current or previous cancer or chemotherapy in the past 5 years
- personal history of alcohol and/or drugs abuse in the previous 3 months
- pregnancy
- diagnosis of type 2 or type 1 diabetes
- personal history of current or previous cancer or chemotherapy in the past 5 years
- personal history of alcohol and/or drugs abuse in the previous 3 months
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Urinary and Serum Levels of miRNA 192 and miRNA 25 and Glomerular Filtration and Albuminuria in Patients With and Without Type 2 Diabetes.
Diabetes kidney disease (DKD) is the leading cause of end stage renal disease (ESRD) in western countries and its incidence is worryingly increasing worldwide. Cardiovascular disease shows a continuous relationship with declining of renal function in type 2 diabetes patients. Moreover, there is a strong evidence of all-cause mortality risk excess even in patients with early stages kidney disease.
MicroRNA (miRNA) are small non-coding RNA molecules, containing 21-25 nucleotides, that modulate post-transcriptional gene expressions. In the past years many human miRNAs involved in the pathogenesis of renal disease have been discovered, such as miR-192, miR-194, miR-204 and miR-25. Among these, miR-192 and miR-25, are receiving greater attention while it seems that they play a role in glomerulosclerosis and renal fibrosis. However too few data are available in large publish trials among patients with renal impairment and the role of serum and urinary levels of miR-192 and miR-25 in people with preserved renal function remain unclear.
To evaluate the association between serum and urinary expression of miR-192 and miR-25 and renal function (according to different extent of renal impairment) in patients with or without type 2 diabetes.
Read the detailed description
The day of the study patients undergo a routine clinical evaluation. Whole blood samples are collected from an antecubital vein to assess serum/plasma aliquots of 200 μl each (frozen at -80°C until required for quantitation) for evaluation of biochemical parameters (fasting glucose, HbA1c, lipid profile, serum creatinine, uric acid, electrolytes, liver function enzymes, albumin) and determination of serum miR-192 and miR-25.
Two urine samples will be also collected to assess aliquots of 200 μl each (frozen at -80°C until required for quantitation) for determination of albumin:creatinine ratio and urine expression of miR-192 and miR-25.
- Conditions
- Diabetic Kidney Disease, Type2 Diabetes
- Being tested
- no interventions required.
- Keywords
- DKD, miRNA-25, miRNA-192
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventions required.Other
The study does not require any interventions.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Type2 Diabetes | 200 patients with type 2 diabetes consecutively enrolled among those referring to our Diabetes outpatient clinic. Receives: Other: no interventions required. | |
| Patients without Type2 Diabetes | 100 patients without diabetes among those referring to our outpatient clinic most of them affected by hypercholesterolemia, obesity or CV disease. Receives: Other: no interventions required. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum expression of miR-192
Levels of miR-192 will be assessed on serum and will be related to glomerular filtration rate and presence or absence of albuminuria (expressed as albumine:creatinine ratio).
Measured: Each patients will be assessed at baseline.
Serum expression of miR-25
Levels of miR-25 will be assessed on serum and will be related to glomerular filtration rate and presence or absence of albuminuria (expressed as albumine:creatinine ratio).
Measured: Each patients will be assessed at baseline.
Urine expression of miR-192
Levels of miR-192 will be assessed on urine and will be related to glomerular filtration rate and presence or absence of albuminuria (expressed as albumine:creatinine ratio).
Measured: Each patients will be assessed at baseline.
Urine expression of miR-25
Levels of miR-25 will be assessed on urine and will be related to glomerular filtration rate and presence or absence of albuminuria (expressed as albumine:creatinine ratio).
Measured: Each patients will be assessed at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start1 Mar 2018
- Primary completion31 Dec 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Solini, University of Pisa
- Investigators
- Anna Solini, MD, PhD, Principal investigator, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176276
- Sponsor's protocol ID
- AS0004
- Status last verified
- Jun 2020
- First submitted
- 21 Nov 2019
- Last updated
- 5 Jun 2020
- 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 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Urinary and Serum Levels of miRNA 192 and miRNA 25 and Glomerular Filtration and Albuminuria in Patients With and Without Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT04176276
- Acronym / sponsor ID
- AS0004
- Conditions
- Diabetic Kidney Disease, Type2 Diabetes
- Keywords
- DKD, miRNA-25, miRNA-192
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 25 Nov 2019 (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.
Diabetes kidney disease (DKD) is the leading cause of end stage renal disease (ESRD) in western countries and its incidence is worryingly increasing worldwide. Cardiovascular disease shows a continuous relationship with declining of renal function in type 2 diabetes patients. Moreover, there is a strong evidence of all-cause mortality risk excess even in patients with early stages kidney disease.
MicroRNA (miRNA) are small non-coding RNA molecules, containing 21-25 nucleotides, that modulate post-transcriptional gene expressions. In the past years many human miRNAs involved in the pathogenesis of renal disease have been discovered, such as miR-192, miR-194, miR-204 and miR-25. Among these, miR-192 and miR-25, are receiving greater attention while it seems that they play a role in glomerulosclerosis and renal fibrosis. However too few data are available in large publish trials among patients with renal impairment and the role of serum and urinary levels of miR-192 and miR-25 in people with preserved renal function remain unclear.
To evaluate the association between serum and urinary expression of miR-192 and miR-25 and renal function (according to different extent of renal impairment) in patients with or without type 2 diabetes.
Detailed description
The day of the study patients undergo a routine clinical evaluation. Whole blood samples are collected from an antecubital vein to assess serum/plasma aliquots of 200 μl each (frozen at -80°C until required for quantitation) for evaluation of biochemical parameters (fasting glucose, HbA1c, lipid profile, serum creatinine, uric acid, electrolytes, liver function enzymes, albumin) and determination of serum miR-192 and miR-25.
Two urine samples will be also collected to assess aliquots of 200 μl each (frozen at -80°C until required for quantitation) for determination of albumin:creatinine ratio and urine expression of miR-192 and miR-25.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Type2 Diabetes | – | Other: no interventions required.200 patients with type 2 diabetes consecutively enrolled among those referring to our Diabetes outpatient clinic. |
| Patients without Type2 Diabetes | – | Other: no interventions required.100 patients without diabetes among those referring to our outpatient clinic most of them affected by hypercholesterolemia, obesity or CV disease. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will consecutively enrolled 300 patients (200 patients with type 2 diabetes and 100 patients without diabetes) among those referring to the Departiment of Diabetes and Metabolic disease, Santa Chiara Hospital, Pisa.
Key inclusion criteria (7 listed)
- age ≥ 18 years and ≤ 75 years
- male or female patients with type 2 diabetes treated with life style modification only or any OAD or insulin
- BMI ≥ 20 e ≤ 40 Kg/m2
- patients able to consent
- age ≥ 18 years and ≤ 75 years
Key exclusion criteria (7 listed)
- personal history of current or previous cancer or chemotherapy in the past 5 years
- personal history of alcohol and/or drugs abuse in the previous 3 months
- pregnancy
- diagnosis of type 2 or type 1 diabetes
- personal history of current or previous cancer or chemotherapy in the past 5 years
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 |
|---|---|---|
| no interventions required.The study does not require any interventions. | Other | Patients with Type2 Diabetes, Patients without Type2 Diabetes |
Primary outcome
Serum expression of miR-192
Time frame: Each patients will be assessed at baseline.
Levels of miR-192 will be assessed on serum and will be related to glomerular filtration rate and presence or absence of albuminuria (expressed as albumine:creatinine ratio).
Serum expression of miR-25
Time frame: Each patients will be assessed at baseline.
Levels of miR-25 will be assessed on serum and will be related to glomerular filtration rate and presence or absence of albuminuria (expressed as albumine:creatinine ratio).
Urine expression of miR-192
Time frame: Each patients will be assessed at baseline.
Levels of miR-192 will be assessed on urine and will be related to glomerular filtration rate and presence or absence of albuminuria (expressed as albumine:creatinine ratio).
Urine expression of miR-25
Time frame: Each patients will be assessed at baseline.
Levels of miR-25 will be assessed on urine and will be related to glomerular filtration rate and presence or absence of albuminuria (expressed as albumine:creatinine ratio).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
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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.
Anna Solini, MD, PhD principal investigator
University of Pisa
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 Diabetic Kidney Disease and Type2 Diabetes, run by University of Pisa at 1 site in Italy.
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 5 Jun 2020. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum expression of miR-192 (time frame: Each patients will be assessed at baseline.). The study lists 4 primary outcomes in all. 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 5 Jun 2020.