NCT03859817

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 68 (estimated)
• Sponsor: University of Milan · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-04-16
• Primary completion: 2021-12-18
• Completion: 2021-12-31
• First posted: 2019-03-01
• Last updated: 2021-09-28

Locations

1 site across 1 country: Italy