Diabetic Nephropathy Type 2TAKEN-DKDNCT03859817
Observational Study to Evaluate the Relationship Between Ketonemia and Renal Function in the Diabetic Patient
An observational study of Diabetic Nephropathy Type 2, run by University of Milan at 1 site in Italy.
Trial summary
A multicentre real life study is proposed. The study has as its goal primary to compare the levels of ketonemia measured in patients with albuminuria and patients normo albuminurici to evaluate a possible correlation between ketone level and alteration of renal function in the diabetic patient, comparing the eGFR… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Nephropathy Type 2
- What is being tested?
- Comparison of eGFR values and ketonemia in diabetic patients
- How many people
- 68 participants
- Where
- 1 siteItaly
- Study dates
- 16 Apr 2019to 31 Dec 2021
- How long will I take part?
- 12 Months
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited based on anamnestic and clinical data and blood and urine parameters specific for type 1 diabetes mellitus and type 2 diabetes mellitus in diabetic nephropathy.
Who may be able to join
- Presence of albuminuria (≥30 mg / 24h)
- Adult and male patients of age
- Diagnosis of type 1 or type 2 diabetes according to the ADA diagnostic criteria
- Presence of the disease for at least five years
- HbA1c≥7%
- Written informed consent of the patient and / or parents or legal guardian
Who cannot join
- Chronic end-stage renal disease (CKD5)
- Current or previous treatments with immunosuppressants (with the exception of topical steroids ed inhalers)
- Participation in other clinical studies
- Significant disease other than diabetes found in the two weeks prior to the first visit
- Neurological or psychiatric diseases, hemoglobinopathies, liver diseases, cancer, cystic fibrosis, renal failure, malabsorption syndromes
- Abuse of alcohol and drugs
Show all 10Show fewer
- HIV or hepatitis
- Pregnant or lactating women (β-HCG urinary should be evaluated before each visit)
- Presence of serious diseases or conditions of the patient considered unsuitable by the Investigator for be able to include it in the study
- Poor understanding by the patient of spoken and written Italian
Trial locations and contacts
1 site in 1 country.
About this study
A multicentre real life study is proposed. The study has as its goal primary to compare the levels of ketonemia measured in patients with albuminuria and patients normo albuminurici to evaluate a possible correlation between ketone level and alteration of renal function in the diabetic patient, comparing the eGFR values of patients with ketonemia high and of patients with low ketonemia. In these patients, the lack of insulin causes one imbalance between ketogenesis and ketolysis, with increased production and reduced body clearance ketones. Several studies explore the effects of ketone bodies on cell function and lesions diabetic complications: ketonemia induces oxidative stress and increases the risk and the progression of complications, moreover, the increase in ketone levels may have pro-inflammatory effects. However, ketonemia levels between normal and DKA are poorly studied and their effects are still unknown. It is hypothesized that
- in diabetic patients with DKD the level of ketones may be high;
- Increased ketone levels may promote an alteration of renal function.
Read more
We want to evaluate the relationship between ketone levels and renal function, because the kidneys, as well as the heart, are among the main organs in which the ketone bodies are oxidized to produce energy and DKD has a high morbidity and mortality in diabetes. The main objectives for being able to demonstrate the hypothesis in question are:
- Evaluate the level of ketones in albuminurate patients with diabetes and in patients with renal function altered;
- Evaluate the association between ketone level and decline of renal function in the diabetic patient e therefore the impact of ketonemia on the progression of renal function loss.
Read the detailed description
At the beginning and during the course of the study the glycemic and ketone index obtained by the homologous blood glucose monitoring will be evaluated. During the study, prognostic biomarkers (sP2X7R, KIM-1, sTNFR1, 11-dehydro-tromoxane B2 and 6-keto-prostaglandin-F-1a (PGF1α)), which are presumed to play an important role in inflammatory renal diseases, will also be measured in diabetic subject, in addition to the traditional marker that is the urinary albumin.
Step 1. Visit Baseline: blood sampling and collection of a urinary sample, evaluation proteinuria, GFR and blood and urinary ketones Step 2. Visit at 6 months: blood collection and collection of a urinary sample, evaluation proteinuria, GFR and blood and urinary ketones Step 3. Visit at 12 months: blood collection and collection of a urinary sample, evaluation proteinuria, GFR and blood and urinary ketones. The study involves the enrollment of T1D and T2D subjects in diabetic nephropathy. The study involves the enrollment of T1D and T2D subjects in diabetic nephropathy A timetable will be prepared for the surgeries during the which the diabetic subject will be informed about the study protocol in question and will provide eventual informed consent to entry into the study, blood sampling and urinary sample collection. However, the analysis will be above all exploratory and will allow to foresee possible studies future properly sized.
- Conditions
- Diabetic Nephropathy Type 2
- Being tested
- Comparison of eGFR values and ketonemia in diabetic patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of eGFR values and ketonemia in diabetic patientsOther
To verify if there is a correlation between the level of ketones and an alteration of the renal function in the diabetic patient, the values of the prognostic markers indicated in the protocol and the data downloaded by the glucometers will be evaluated in addition to the blood tests of the patients
| Study group | Role | What they receive |
|---|---|---|
| Patients with albuminuria | Comparison of eGFR values and ketonemia in diabetic patients Receives: Other: Comparison of eGFR values and ketonemia in diabetic patients | |
| patients with normo albuminuria | Comparison of eGFR values and ketonemia in diabetic patients Receives: Other: Comparison of eGFR values and ketonemia in diabetic patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variations in albuminuria and albumin / creatinine ratio in urine (UACR)
immunoturbidimetric method
Measured: 12 months
Variations of the eGFR (CKD-EPI formula)
CKD-EPI formula
Measured: 12 months
Variations in ketone levels
monitoring ketones in capillary and urinary samples
Measured: 12 months
Secondary outcomes (3)
Variations of tubular function markers (sP2X7R, KIM-1, sTNFR1)
enzyme immunoassay (ELISA)
Measured: 12 months
Variations of markers of glomerular function (11-dehydro-tromoxane B2 and 6-keto-prostaglandin- F-1a (PGF1α))
enzyme immunoassay (ELISA)
Measured: 12 months
Changes in glycated hemoglobin (HbA1c)
capillary electrophoresis
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start16 Apr 2019
- Primary completion18 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Nephropathy Type 2Studies 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
- Prospective
- Enrolment
- 68 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Fiorina, MD, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859817
- Sponsor's protocol ID
- 2018/ST/043
- Acronym
- TAKEN-DKD
- Status last verified
- Sep 2021
- First submitted
- 28 Feb 2019
- Last updated
- 28 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Evaluate the Relationship Between Ketonemia and Renal Function in the Diabetic Patient
- ClinicalTrials.gov ID
- NCT03859817
- Acronym / sponsor ID
- TAKEN-DKD / 2018/ST/043
- Conditions
- Diabetic Nephropathy Type 2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 18 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 1 Mar 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.
A multicentre real life study is proposed. The study has as its goal primary to compare the levels of ketonemia measured in patients with albuminuria and patients normo albuminurici to evaluate a possible correlation between ketone level and alteration of renal function in the diabetic patient, comparing the eGFR values of patients with ketonemia high and of patients with low ketonemia. In these patients, the lack of insulin causes one imbalance between ketogenesis and ketolysis, with increased production and reduced body clearance ketones. Several studies explore the effects of ketone bodies on cell function and lesions diabetic complications: ketonemia induces oxidative stress and increases the risk and the progression of complications, moreover, the increase in ketone levels may have pro-inflammatory effects. However, ketonemia levels between normal and DKA are poorly studied and their effects are still unknown. It is hypothesized that
- in diabetic patients with DKD the level of ketones may be high;
- Increased ketone levels may promote an alteration of renal function.
We want to evaluate the relationship between ketone levels and renal function, because the kidneys, as well as the heart, are among the main organs in which the ketone bodies are oxidized to produce energy and DKD has a high morbidity and mortality in diabetes. The main objectives for being able to demonstrate the hypothesis in question are:
- Evaluate the level of ketones in albuminurate patients with diabetes and in patients with renal function altered;
- Evaluate the association between ketone level and decline of renal function in the diabetic patient e therefore the impact of ketonemia on the progression of renal function loss.
Detailed description
At the beginning and during the course of the study the glycemic and ketone index obtained by the homologous blood glucose monitoring will be evaluated. During the study, prognostic biomarkers (sP2X7R, KIM-1, sTNFR1, 11-dehydro-tromoxane B2 and 6-keto-prostaglandin-F-1a (PGF1α)), which are presumed to play an important role in inflammatory renal diseases, will also be measured in diabetic subject, in addition to the traditional marker that is the urinary albumin.
Step 1. Visit Baseline: blood sampling and collection of a urinary sample, evaluation proteinuria, GFR and blood and urinary ketones Step 2. Visit at 6 months: blood collection and collection of a urinary sample, evaluation proteinuria, GFR and blood and urinary ketones Step 3. Visit at 12 months: blood collection and collection of a urinary sample, evaluation proteinuria, GFR and blood and urinary ketones. The study involves the enrollment of T1D and T2D subjects in diabetic nephropathy. The study involves the enrollment of T1D and T2D subjects in diabetic nephropathy A timetable will be prepared for the surgeries during the which the diabetic subject will be informed about the study protocol in question and will provide eventual informed consent to entry into the study, blood sampling and urinary sample collection. However, the analysis will be above all exploratory and will allow to foresee possible studies future properly sized.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with albuminuria | – | Other: Comparison of eGFR values and ketonemia in diabetic patientsComparison of eGFR values and ketonemia in diabetic patients |
| patients with normo albuminuria | – | Other: Comparison of eGFR values and ketonemia in diabetic patientsComparison of eGFR values and ketonemia in diabetic patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited based on anamnestic and clinical data and blood and urine parameters specific for type 1 diabetes mellitus and type 2 diabetes mellitus in diabetic nephropathy.
Key inclusion criteria (6 listed)
- Presence of albuminuria (≥30 mg / 24h)
- Adult and male patients of age
- Diagnosis of type 1 or type 2 diabetes according to the ADA diagnostic criteria
- Presence of the disease for at least five years
- HbA1c≥7%
Key exclusion criteria (10 listed)
- Chronic end-stage renal disease (CKD5)
- Current or previous treatments with immunosuppressants (with the exception of topical steroids ed inhalers)
- Participation in other clinical studies
- Significant disease other than diabetes found in the two weeks prior to the first visit
- Neurological or psychiatric diseases, hemoglobinopathies, liver diseases, cancer, cystic fibrosis, renal failure, malabsorption syndromes
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 |
|---|---|---|
| Comparison of eGFR values and ketonemia in diabetic patientsTo verify if there is a correlation between the level of ketones and an alteration of the renal function in the diabetic patient, the values of the prognostic markers indicated in the protocol and the data downloaded by the glucometers will be evaluated in addition to the blood tests of the patients | Other | Patients with albuminuria, patients with normo albuminuria |
Primary outcome
Variations in albuminuria and albumin / creatinine ratio in urine (UACR)
Time frame: 12 months
immunoturbidimetric method
Variations of the eGFR (CKD-EPI formula)
Time frame: 12 months
CKD-EPI formula
Variations in ketone levels
Time frame: 12 months
monitoring ketones in capillary and urinary samples
3 secondary outcomes
Variations of tubular function markers (sP2X7R, KIM-1, sTNFR1)
Time frame: 12 months
Variations of markers of glomerular function (11-dehydro-tromoxane B2 and 6-keto-prostaglandin- F-1a (PGF1α))
Time frame: 12 months
Changes in glycated hemoglobin (HbA1c)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Nephropathy Type 2, run by University of Milan 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 6 inclusion and 10 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 28 Sep 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 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?
Results are not available in the source record.
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?
Variations in albuminuria and albumin / creatinine ratio in urine (UACR) (time frame: 12 months). The study lists 3 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 28 Sep 2021.