2024-511867-27-00招募中3 期
Impact of Metformin on Peripheral Arterial Calcification in Type 1 Diabetes (IMPACT-1D)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Difference between below-knee arterial calcification score evaluated by CT-scan at T0 and T2years in type 1 diabetic patients treated or not with metformin.
研究概览
简要总结
To show that metformin, patients with type 1 diabetes but without chronic kidney disease, is able to slow below- knee arterial calcification
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes
- •Women and Men ≥ 18 years old and ≤ 80 years old with: *Complications: -diabetic retinopathy and/or -nephropathy (with creatinine clearance ≥ 60 mL/mn) and/or -neuropathy and/or -peripheral arterial occlusive disease and/or -cardiopathy and/or -stroke and/or *cardiovascular risk factors - hypertension and/or - dyslipidemia (HDL < 0.35g/L or LDL > 1.9g/L or treated dyslipidemia) and/or - tobacco use (old or active smoking greater than 5 pack years) and/or *Diabetes duration >20 years
- •For women in childbearing age, effective contraception during the whole trial
- •Signed written informed consent
- •Affiliation of a social security regime (patient with AME cannot be included)
排除标准
- •Creatinine clearance of less than 3 months <60 mL/mn (MDRD) at the inclusion time
- •Patient under legal protection measure (tutorship or curatorship) or deprived of freedom or under measure of safety
- •Unable to consent
- •Known metformin contra-indication: • severe liver insufficiency –CHILD B or C • heart failure (FEVG<45%) or • history of pulmonary oedema, respiratory insufficiency with history of acute respiratory failure or patients receiving oxygen therapy • chronic ethylism • lactic acidosis
- •Known hypersensitivity to metformin or to any of its excipients or placebo excipients (lactose)
- •Indication or history of lower limb angioplasty (with stenting) and/or bypass
- •Previous treatment with metformin (within 3 months prior to inclusion)
- •HbA1c of less than 3 months >11%
- •Chronic inflammatory disease or chronic immune-suppressive drugs intake
- •Participation in an another interventional trial (Jardé 1 and 2) or in the exclusion period of any other interventional study
- •Pregnancy woman (confirmed by a sanguine beta-HCG test) or breastfeeding woman
结局指标
主要结局
Difference between below-knee arterial calcification score evaluated by CT-scan at T0 and T2years in type 1 diabetic patients treated or not with metformin.
Difference between below-knee arterial calcification score evaluated by CT-scan at T0 and T2years in type 1 diabetic patients treated or not with metformin.
次要结局
- Difference between below-knee arterial ultrasonographic occlusion score at T0 and T2years in type 1 diabetic patients supplemented or not with metformin.
- Difference between ankle and toe brachial indexes at T0 and T2years in type 1 diabetic patients supplemented or not with metformin.
- Difference between pulse wave velocity at T0 and T2 years in type 1 diabetic patients supplemented or not with metformin.
- Difference between coronary calcification score evaluated by CT-scan at T0 and T2years in type 1 diabetic patients treated or not with metformin.
- Difference between below-knee arterial calcification score progression between T0 and T2years in type 1 diabetic patients treated or not with metformin and with initial below-knee arterial calcification score ≤ and >400.
研究者
Coordinating Investigator
Scientific
Assistance Publique Hopitaux De Paris
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Effect of Diabetic Foot Exercises on Peripheral Vascular Status in Type 2 Diabetes Mellitus PatientsNCT07262203Universitas Muhammadiyah Surakarta44
尚未招募
1 期
Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD ExacerbationsNCT07275359Duke University45
尚未招募
不适用
Carotid Doppler Screening for Subclinical Atherosclerosis in Diabetic CKD Patients.Diabetes Mellitus, Type 2Chronic Kidney DiseaseAtherosclerosisNCT07266220Abdallah Ali Mohammed96
终止
3 期
Peripheral and Coronary Endothelial Dysfunction In Type 2diabetic Patients- Role of MetforminCoronary and Peripheral Endothelial DysfunctionNCT00169624Hospices Civils de Lyon30
招募中
不适用
Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle MassGLP-1ObesityDiabetesType 2 DiabetesNCT07272837University of Alberta50