Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03859817 |
| Other study ID # |
2018/ST/043 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 16, 2019 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
September 2021 |
| Source |
University of Milan |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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 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.
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.
