2026-527080-15-00招募中4 期
Phase IV Low Intervention Clinical Trial to Study Biomarkers of "inflammageing" and Senescence in Pre-diabetic Patients Treated with Metformin: A Study nested within the project “NLRP3 Inflammasome at the Crossroad of Vascular Inflammageing: A Novel Target for Senomorphic Drugs”.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Circulating levels of NLRP3 inflammasome end-products (IL-1β, IL-18) at 0, 6, 12, and 18 months.
研究概览
简要总结
To assess changes in biomarkers of NLRP3 inflammasome activation and resulting end-product in pre-diabetic patients treated with metformin compared to those not receiving treatment.
研究设计
- 分配方式
- Randomized
- 主要目的
- Phase IV Low Intervention Clinical Trial to Study Biomarkers of "inflammageing" and Senescence in Pr
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Arms A & B: Prediabetic subjects - Adults, male and female, aged 18-60 - Must present at least one criteria of pre-diabetes: basal glycaemia of 110-125 mg/dL measured twice or 140-199 mg/dL after 2h of glucose tolerance test (75 g), or HbA1c between 5.7-6.4%. - BMI between 18-35 kg/m2
- •Arm C: Healthy controls - Adults, male and female, aged 18-60 - BMI between 18-35 kg/m2 - Basal glycaemia <110mg/dL and HbA1c <5.7% - Absence of other CV risk factors at screening, defined as high blood pressure (BP ≥ 130/80 mmHg) and high blood cholesterol (total cholesterol ≥ 240 mg/dL or LDL-c ≥ 160).
排除标准
- •Participants are not willing or able to comply with: all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, or other study procedures.
- •Participants who are currently under medical follow-up for any medical condition (besides prediabetes for Arms A & B) or who are regularly taking medication for any condition, including any diabetic treatment.
- •Have a known history of drug substance abuse.
- •Active smokers or former smokers who quit less than 12 months prior to screening.
- •Any other condition that, in the opinion if the Investigator, may interfere with the outcome evaluation of the trial.
- •Any condition or situation precluding or interfering with the compliance with the protocol.
- •Women of childbearing potential (WOCBP) who plan to become pregnant during the 18-month study period.
- •Participant is currently enrolled or has enrolled in a clinical trial three months prior to inclusion in the current study.
研究组 & 干预措施
Dianben 850 mg comprimidos recubiertos con película
Test
干预措施: Dianben 850 mg comprimidos recubiertos con película (Drug)
结局指标
主要结局
Circulating levels of NLRP3 inflammasome end-products (IL-1β, IL-18) at 0, 6, 12, and 18 months.
Circulating levels of NLRP3 inflammasome end-products (IL-1β, IL-18) at 0, 6, 12, and 18 months.
次要结局
- Circulating levels of other biomarkers for inflammation (IL6, MCP-1, TNFα, IL10), endothelial activation (sICAM, sVCAM, sE-selectin), coagulation (vWF, ADAMTS-13, D-dimer), senescence (miR-106a), oxidative stress (SOD activity, sklotho), and other parameters of endothelial dysfunction (CRP) at 0, 6, 12, and 18 months.
- Levels of small extracellular vesicles and large extracellular vesicles, as well as their cargo, including NLRP3 inflammasome components (pp65, NLRP3, ASC, caspase-1), IL-1β, senescence markers (p16, p21, p53, γH2AX) and senescence-related miRNAs (miR-106a) at 0, 6, 12 and 18 months.
- Levels of NLRP3 inflammasome components (pp65, NLRP3, ASC, caspase-1), IL-1β, senescence markers (p16, p21, p53, γH2AX), klotho, Nrf2-heme oxygenase 1 (HO-1) axis, levels of antioxidant enzymes (superoxide dismutase (SOD), catalase (CAT)) and mitochondrial function measured by metabolic flux analyzer (Seahorse) in PBMNCs at 0, 6, 12 and 18 months.
- Changes in BMI, glycemia, HbA1c and lipid profile (Total cholesterol, LDL, HDL and triglycerides) at 0, 6, 12 and 18 months.
- Changes in levels of NLRP3 inflammasome components (pp65, NLRP3, ASC, caspase-1), IL-1β, senescence markers (p16, p21, p53, γH2AX), klotho, COX-2, Nrf2-heme oxygenase 1 (HO-1) axis), levels of antioxidant enzymes (superoxide dismutase (SOD), catalase (CAT)), mitochondrial function measured by metabolic flux analyzer (Seahorse) and other cytokines (TNF-α, IL-6, MCP-1, IL10) in PBMNCs after IL-1β stimulation. Changes in levels, size and complexity and cargo components of extracellular vesicles rel
- Changes in levels, size, complexity and cargo components of extracellular vesicles released by PBMNCs after IL-1β stimulation.
研究者
Carlos Félix Sánchez Ferrer
Scientific
Universidad Autonoma De Madrid
研究点 (1)
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