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NCT03859817: TAKEN-DKD
Observational Study to Evaluate the Relationship Between Ketonemia and Renal Function in the Diabetic Patient
trial testing Comparison of eGFR values and ketonemia in diabetic patients in Diabetic Nephropathy Type 2 in 68 participants. Status unknown.
18 December 2021
Quick facts
| Lead sponsor | University of Milan |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 68 |
| Start date | 16 April 2019 |
| Primary completion | 18 December 2021 |
| Estimated completion | 31 December 2021 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Comparison of eGFR values and ketonemia in diabetic patients
Conditions studied
- Diabetic Nephropathy Type 2 — all drugs for Diabetic Nephropathy Type 2 →
Sponsor
University of Milan
Who can join
Adults 18 to 80, any sex, with Diabetic Nephropathy Type 2. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03859817
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03859817 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Milan
- Last refreshed: 28 September 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03859817.
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