Oxidative stress markers in adults with type 1 diabetes versus LADA.
Evaluation of Oxidative Stress: Comparison Between Type 1 Diabetes Mellitus and Latent Autoimmune Diabetes in Adults
This project will see if blood markers of oxidative stress differ between adults with type 1 diabetes and adults with LADA.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia, Pavia) |
| Trial ID | NCT07434154 on ClinicalTrials.gov |
What this trial studies
This is an observational study enrolling 75 adults with type 1 diabetes and 75 adults with latent autoimmune diabetes in adults (LADA), all aged 18–75 and recruited from the outpatient diabetes center at IRCCS Policlinico San Matteo. Participants undergo a single visit for medical history and blood sample collection to measure pro-oxidant and antioxidant markers (d-ROMs, BAP, OXY-Adsorbent, -SHp, anti-ROMs) using the FREE Duo analyzer. For newly diagnosed (incident) cases a follow-up visit at 3 months will compare changes in HbA1c with changes in the oxidative biomarkers. Secondary analyses will examine associations between biomarkers and glycemic control and whether biomarkers cluster differently by diagnosis.
Who should consider this trial
Good fit: Adults aged 18–75 with known or newly diagnosed type 1 diabetes or LADA who can give informed consent and attend the outpatient clinic at IRCCS Policlinico San Matteo are ideal candidates.
Not a fit: People younger than 18 or older than 75, those without T1DM or LADA, or anyone unable or unwilling to provide informed consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could identify oxidative stress biomarkers that help distinguish T1DM from LADA and guide more tailored monitoring or interventions.
How similar studies have performed: Oxidative stress markers have been studied broadly in diabetes, but direct head-to-head comparisons between T1DM and LADA are limited, making this a relatively novel comparison.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients with with already known or newly diagnosed type 1 diabetes mellitus or LADA Patients aged ≥ 18 years and ≤ 75 years Patients of both sexes All patients will be selected among outpatients attending the Center of Diabetes and Metabolic Diseases of First Department of Internal Medicine, IRCCS Policlinico San Matteo Foundation. Exclusion Criteria: Patients refusing to sign informate consent.
Where this trial is running
Pavia, Pavia
- Fondazione IRCCS Policlinico San Matteo di Pavia — Pavia, Pavia, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.