Observational Study to Evaluate the Relationship Between Ketonemia and Renal Function in the Diabetic Patient

NCT03859817 | Unknown

• 1 other identifier: 2018/ST/043
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Nephropathy Type 2

Outcome Measures

Primary Outcomes (3)

• Variations in albuminuria and albumin / creatinine ratio in urine (UACR)

  immunoturbidimetric method

  12 months

• Variations of the eGFR (CKD-EPI formula)

  CKD-EPI formula

  12 months

• Variations in ketone levels

  monitoring ketones in capillary and urinary samples

  12 months

Secondary Outcomes (3)

• Variations of tubular function markers (sP2X7R, KIM-1, sTNFR1)

  12 months

• Variations of markers of glomerular function (11-dehydro-tromoxane B2 and 6-keto-prostaglandin- F-1a (PGF1α))

  12 months

• Changes in glycated hemoglobin (HbA1c)

  12 months

Study Arms (2)

Patients with albuminuria

Comparison of eGFR values and ketonemia in diabetic patients

Other: Comparison of eGFR values and ketonemia in diabetic patients

patients with normo albuminuria

Comparison of eGFR values and ketonemia in diabetic patients

Other: Comparison of eGFR values and ketonemia in diabetic patients

Interventions

Comparison of eGFR values and ketonemia in diabetic patients OTHER

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 albuminuria; patients with normo albuminuria

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

ASST FBF-Sacco P.O. Sacco/Fatebenefratelli e Oftalmico

Milan, 20157, Italy

Location

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)

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 1, 2019
• Study Start: April 16, 2019
• Primary Completion: December 18, 2021
• Study Completion: December 31, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

IT (1)