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临床试验/NCT07434154
NCT07434154招募中不适用

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

Fondazione IRCCS Policlinico San Matteo di Pavia1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
75
试验地点
1
主要终点
Oxidative stress biomarkers

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Patients refusing to sign informate consent.

研究组 & 干预措施

Type 1 diabetes mellitus

Latent Autoimmune Diabetes in Adult

Latent Autoimmune Diabetes in Adult

结局指标

主要结局

Oxidative stress biomarkers

时间窗: 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. We will also evaluate high sensitivity C-reactive protein (Hs-CRP), superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), malondialdehyde (MDA).

次要结局

  • Glycemic control(Three months)

研究者

发起方
Fondazione IRCCS Policlinico San Matteo di Pavia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giuseppe Derosa

Principal Investigator

Fondazione IRCCS Policlinico San Matteo di Pavia

研究点 (1)

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