Status:
UNKNOWN
Observational Study to Evaluate the Relationship Between Ketonemia and Renal Function in the Diabetic Patient
Lead Sponsor:
University of Milan
Conditions:
Diabetic Nephropathy Type 2
Eligibility:
All Genders
18-80 years
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 poss...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 16 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT03859817
Start Date
April 16 2019
End Date
December 31 2021
Last Update
September 28 2021
Active Locations (1)
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1
ASST FBF-Sacco P.O. Sacco/Fatebenefratelli e Oftalmico
Milan, Italy, 20157