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Observational Study to Evaluate the Relationship Between Ketonemia and Renal Function in the Diabetic Patient (TAKEN-DKD)

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ClinicalTrials.gov Identifier: NCT03859817
Recruitment Status : Active, not recruiting
First Posted : March 1, 2019
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Paolo Fiorina, MD, University of Milan

Brief 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 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.

Condition or disease Intervention/treatment
Diabetic Nephropathy Type 2 Other: Comparison of eGFR values and ketonemia in diabetic patients

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 68 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Observational Study to Evaluate the Relationship Between Ketonemia and Renal Function in the Diabetic Patient
Actual Study Start Date : April 16, 2019
Estimated Primary Completion Date : April 18, 2021
Estimated Study Completion Date : December 18, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests

Group/Cohort Intervention/treatment
Patients with albuminuria
Comparison of eGFR values and ketonemia in diabetic patients
Other: Comparison of eGFR values and ketonemia in diabetic patients
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

patients with normo albuminuria
Comparison of eGFR values and ketonemia in diabetic patients
Other: Comparison of eGFR values and ketonemia in diabetic patients
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




Primary Outcome Measures :
  1. Variations in albuminuria and albumin / creatinine ratio in urine (UACR) [ Time Frame: 12 months ]
    immunoturbidimetric method

  2. Variations of the eGFR (CKD-EPI formula) [ Time Frame: 12 months ]
    CKD-EPI formula

  3. Variations in ketone levels [ Time Frame: 12 months ]
    monitoring ketones in capillary and urinary samples


Secondary Outcome Measures :
  1. Variations of tubular function markers (sP2X7R, KIM-1, sTNFR1) [ Time Frame: 12 months ]
    enzyme immunoassay (ELISA)

  2. Variations of markers of glomerular function (11-dehydro-tromoxane B2 and 6-keto-prostaglandin- F-1a (PGF1α)) [ Time Frame: 12 months ]
    enzyme immunoassay (ELISA)

  3. Changes in glycated hemoglobin (HbA1c) [ Time Frame: 12 months ]
    capillary electrophoresis


Biospecimen Retention:   Samples Without DNA
Collection of blood sample for immunological study (blood sampling to be performed on fasting) Urine sample collection for immunological study (collection carried out on the day of the visit)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859817


Locations
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Italy
ASST FBF-Sacco P.O. Sacco/Fatebenefratelli e Oftalmico
Milano, Italy, 20157
Sponsors and Collaborators
University of Milan
Additional Information:

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Responsible Party: Paolo Fiorina, MD, Clinical Professor, University of Milan
ClinicalTrials.gov Identifier: NCT03859817    
Other Study ID Numbers: 2018/ST/043
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases