Evaluation of Oxidative Stress: Comparison Between Type 1 Diabetes Mellitus and Latent Autoimmune Diabetes in Adults

March 28, 2026 updated by: Giuseppe Derosa, Fondazione IRCCS Policlinico San Matteo di Pavia
After obtaining informed consent, the investigators will recruit 75 patients with T1DM and 75 with LADA with an age ≥ 18 years and ≤ 75 years, 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. The study design will include one single visit where patients' medical history and blood samples will be collected. For incident cases, a follow-up visit at 3 months from the start of treatment will be scheduled to assess whether a decrease in HbA1c corresponds to a decrease in the biomarkers. For a comprehensive oxidative balance evaluation, the d-ROMs test will be carried out to evaluate the pro-oxidant status linked to one of the parameters related to the antioxidant potential (BAP test, OXY-Adsorbent test, -SHp test and anti-ROMs test). Parameters will be evaluated using Free Radical Elective Evaluator (FREE) Duo by Diacron International s.r.l. (Grosseto, ITALY), an integrated analytical system that permits any type of chemical-clinical analysis based on the principle of photometry. The investigators will also evaluate high sensitivity C-reactive protein (Hs-CRP), superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), malondialdehyde (MDA). To evaluate if there is an association between a worse stage of the diseases and some oxidative stress markers, the investigators will also evaluate glycated hemoglobin (HbA1c) fasting plasma glucose (FPG), post-prandial glucose (PPG). All plasmatic parameters will be determined after a 12-h overnight fast, with the exception of PPG, determined 2 hours after a standardized meal. Venous blood samples will be taken for all patients between 8 A.M. and 9 A.M. The investigators will use plasma obtained by addition of Na2-ethylenediaminetetraacetic acid (EDTA), 1 mg/ml, and centrifuged at 3000 g for 15 minutes at 4°C. Immediately after centrifugation, the plasma samples will be frozen and stored at -80 °C for no more than 3 months. All measurements will be analyzed by the Laboratory of Molecular Medicine, General Medicine 1, IRCCS Policlinico San Matteo Foundation with proven experience in the dosage of these markers.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The aim of this observational study will be to evaluate the levels of the main oxidative stress markers in T1DM and LADA and to identify if there are some oxidative stress markers specific for the two diseases. Secondary objectives will be to evaluate if there is an association between oxidative stress markers and severity of the diseases.

Primary aim:

Verify whether biomarkers levels depend on the type of disease (T1DM vs LADA), while adjusting for patients' characteristics.

Secondary aims:

2.1) Verify whether biomarkers levels are associated with glycemic control (FPG, HbA1c, PPG).

2.2) In incident cases, to assess whether a decrease in HbA1c corresponds to a decrease in the biomarkers at 3 months from start of treatment within each disease.

2.3) Verify whether these biomarkers tend to form clusters, overall and by diagnosis.

After obtaining informed consent, the investigators will recruit 75 patients with T1DM and 75 with LADA with an age ≥ 18 years and ≤ 75 years, 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. The study design will include one single visit where patients' medical history and blood samples will be collected. For incident cases, a follow-up visit at 3 months from the start of treatment will be scheduled to assess whether a decrease in HbA1c corresponds to a decrease in the biomarkers. For a comprehensive oxidative balance evaluation, the d-ROMs test will be carried out to evaluate the pro-oxidant status linked to one of the parameters related to the antioxidant potential (BAP test, OXY-Adsorbent test, -SHp test and anti-ROMs test). Parameters will be evaluated using Free Radical Elective Evaluator (FREE) Duo by Diacron International s.r.l. (Grosseto, ITALY), an integrated analytical system that permits any type of chemical-clinical analysis based on the principle of photometry. The investigators will also evaluate high sensitivity C-reactive protein (Hs-CRP), superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), malondialdehyde (MDA). To evaluate if there is an association between a worse stage of the diseases and some oxidative stress markers, the investigators will also evaluate glycated hemoglobin (HbA1c) fasting plasma glucose (FPG), post-prandial glucose (PPG). All plasmatic parameters will be determined after a 12-h overnight fast, with the exception of PPG, determined 2 hours after a standardized meal. Venous blood samples will be taken for all patients between 8 A.M. and 9 A.M. The investigators will use plasma obtained by addition of Na2-ethylenediaminetetraacetic acid (EDTA), 1 mg/ml, and centrifuged at 3000 g for 15 minutes at 4°C. Immediately after centrifugation, the plasma samples will be frozen and stored at -80 °C for no more than 3 months. All measurements will be analyzed by the Laboratory of Molecular Medicine, General Medicine 1, IRCCS Policlinico San Matteo Foundation with proven experience in the dosage of these markers. The investigators will study 10 biomarkers. The sample size calculation is based on feasibility. The investigators expect to enrol 75 patients with T1DM and 75 patients with LADA, of both sexes, aged ≥ 18 and ≤ 75 years.

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with with already known or newly diagnosed type 1 diabetes mellitus or Latent Autoimmune Diabetes in Adult with an age ≥ 18 years and ≤ 75 years, 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Type 1 diabetes mellitus
Latent Autoimmune Diabetes in Adult
Latent Autoimmune Diabetes in Adult

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxidative stress biomarkers
Time Frame: Three months
For a comprehensive oxidative balance evaluation, the d-ROMs test will be carried out to evaluate the pro-oxidant status. Test will include BAP test, OXY-Adsorbent test, -SHp test and anti-ROMs test. Parameters will be evaluated using Free Radical Elective Evaluator (FREE) Duo by Diacron International s.r.l. (Grosseto, ITALY), an integrated analytical system that permits any type of chemical-clinical analysis based on the principle of photometry. The investigators will also evaluate high sensitivity C-reactive protein (Hs-CRP), superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), malondialdehyde (MDA).
Three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic control
Time Frame: Three months
Verify glycemic control (fasting plasma glucose, glycated hemoglobin, post-prandial glucose).
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

December 8, 2025

First Submitted That Met QC Criteria

February 22, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 28, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMT1 vs LADA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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