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临床试验/NCT04879511
NCT04879511已完成2 期

Effect of Metformin on Circulating Neuregulin-4 in Children With Type 1 Diabetes

Ain Shams University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年2月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
80
试验地点
1
主要终点
Glycemic control(HbA1c%)

研究概览

简要总结

Cardiovascular disease is the leading cause of mortality in type 1 diabetes mellitus (T1DM). Vascular dysfunction is an early and critical event in the development of cardiovascular disease. Children with T1DM have vascular dysfunction therefore early interventions to improve vascular health are essential to reduce cardiovascular mortality in T1DM. Metformin is an insulin sensitising agent which is known to improve vascular health outcomes in type 2 diabetes mellitus (T2DM) and other individuals with insulin resistance. It has been used safely in children and adolescents with T2DM for over 10 years. This study aims to assess the effect of metformin on vascular health in children with T1DM.

This is the first study to study effect of metformin on circulating neuregulin-4 levels as a marker for subclinical atherosclerosis.

详细描述

Type 1 diabetes mellitus (T1DM) is an autoimmune disease characterized by T-cell mediated destruction of the pancreatic b-cells, resulting in insulin deficiency and elevated blood glucose levels.

The increasing incidence of type 1 diabetes mellitus in many countries challenges health systems because the disease is presently incurable with no known method of prevention. Around 490,100 children live with the disease worldwide, with incidence estimated to be increasing in children under 15 years by 2.8% per year .This trend is particularly worrying because type 1 diabetes increases mortality and morbidity population-wide.

Vascular co-morbid diseases include retinopathy, which may cause reduced vision and blindness, and nephropathy, which may result in renal failure and require dialysis or kidney transplantation. This is in addition to hypertension, which is linked to peripheral, cardio- and cerebrovascular disease, the end points of which are limb amputations, cardiac failure, stroke and sudden death. As vascular complications curtail both life expectancy and quality of life development at younger ages when people are typically establishing Type 1 diabetes mellitus (T1DM) is an autoimmune disease characterized by T-cell mediated destruction of the pancreatic b-cells, resulting in insulin deficiency and elevated blood glucose levels.

The increasing incidence of type 1 diabetes mellitus in many countries challenges health systems because the disease is presently incurable with no known method of prevention . Around 490,100 children live with the disease worldwide, with incidence estimated to be increasing in children under 15 years by 2.8% per year .This trend is particularly worrying because type 1 diabetes increases mortality and morbidity population-wide.

Vascular co-morbid diseases include retinopathy, which may cause reduced vision and blindness, and nephropathy, which may result in renal failure and require dialysis or kidney transplantation. This is in addition to hypertension, which is linked to peripheral, cardio- and cerebrovascular disease, the end points of which are limb amputations, cardiac failure, stroke and sudden death. As vascular complications curtail both life expectancy and quality of life development at younger ages when people are typically establishing careers and families is particularly detrimental .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Patients with type 1 diabetes mellitus (5 years duration at least) and with micro-vascular complications.
  • Patients on regular visits to clinic.
  • Patients on regular insulin therapy.

排除标准

  • Any clinical evidence of infection, hematological diseases, tumors, liver dysfunction, urinary tract disorders, connective tissue disease, or other autoimmune diseases.

研究组 & 干预措施

Receiving metformin

Active Comparator

Active group receiving metformin with basal /bolus insulin

干预措施: metformin (Drug)

Receiving metformin

Active Comparator

Active group receiving metformin with basal /bolus insulin

干预措施: Basal/bolus insulin (Drug)

Placebo

Placebo Comparator

Control group receiving Placebo with basal/bolus insulin

干预措施: Basal/bolus insulin (Drug)

结局指标

主要结局

Glycemic control(HbA1c%)

时间窗: up to 24 weeks

Effect of metformin supplementation on Glycemic control(HbA1c%)

次要结局

  • circulating neuregulin-4 level(up to 24 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nancy Samir Elbarbary

Prof.of Pediatrics

Ain Shams University

研究点 (1)

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