NCT05467514已完成3 期
Effect of Liraglutide on Subclinical Atherosclerosis in Patients With Type 1 Diabetes Mellitus
David Sanchez Garcia1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2022年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- To assess the effect of liraglutide on carotid intima media thickness in patients with type 1 diabetes mellitus.
研究概览
简要总结
The aim of the trail is investigate the effect of liraglutide 1.8mg as add-on to insulin for 6 months on carotid intima media thickness and cardiovascular risk factors in subjects with type 1 diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 15 to 60 years
- •Patients diagnosed with Type 1 Diabetes Mellitus.
- •Diabetes duration more than 1 year.
- •Both genders.
- •C - peptide less than 0.3 nmol/L
排除标准
- •Patients with type 2 diabetes mellitus, LADA (latent autoimmune diabetes in adults), MODY (maturity-onset diabetes of youth), or other types of diabetes other than type 1 diabetes mellitus.
- •Pregnant patients or desire to become pregnant in the next 6 months.
- •Family history of medullary thyroid cancer or multiple endocrine neoplasia 2
- •History of pancreatitis
- •Familial hypercholesterolemia
- •Use of adjunctive treatment to insulin (SGLT-2 [sodium-glucose cotransporter-2] inhibitor, Pramlintide, metformin)
- •Start of treatment with statins, ezetimibe or PSCK9 (proprotein convertase subtilisin/kexin type 9) inhibitors, amlodipine, metoprolol in the last 6 months before the study.
- •Bariatric surgery
- •Use of medications (immunosuppressants, calcineurin inhibitors, mTOR (mammilian target of rapamycin) inhibitors, corticosteroids, aspirin, or anticoagulants)
- •Metabolic abnormalities (inborn errors of cholesterol storage metabolism, glycogen storage, abetalipoproteinemia, Reye's disease, LCAT (lecithin-cholesterol acyltransferase) deficiency)
研究组 & 干预措施
Liraglutide
Experimental
Application of liraglutide 1.8 mg subcutaneous daily for 6 months to evaluate subclinical atherosclerosis, by means of carotid doppler US, lipid profile in patients with type 1 diabetes mellitus
干预措施: Liraglutide (Drug)
结局指标
主要结局
To assess the effect of liraglutide on carotid intima media thickness in patients with type 1 diabetes mellitus.
时间窗: Baseline and 6 months
Change from baseline measure of right carotid intima media thickness with doppler ultrasound at 6 months in patients with type 1 diabetes mellitus who meet inclusion criteria.
次要结局
- To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers (BMI, weight and abdominal circumference)(0, 1, 2, 3, 4, 5 and 6 months)
- To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers. Somatometry (BMI, weight and abdominal circumference)(0, 1, 2, 3, 4, 5 and 6 months)
- To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers Laboratory studies (total cholesterol, LDL, HDL, triglycerides, non-HDL cholesterol)(0, 3 and 6 months)
- To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers Laboratory studies (HbA1c)(0, 3 and 6 months)
- To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers. eGDR (Estimated glucose disposal rate)(0, 3 and 6 months)
研究者
David Sanchez Garcia
Principal Investigator David Sanchez Garcia
Instituto Mexicano del Seguro Social
研究点 (1)
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