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临床试验/NCT03710811
NCT03710811Unknown不适用

Observational Study of Drug Naive Type 2 Diabetes Receiving Continuous Subcutaneous Insulin Infusion Therapy

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
2
主要终点
Circulating immunity cell profiles

研究概览

简要总结

A multi-centre, open-label trial to investigate the efficacy and possible mechanism of Continuous Subcutaneous Insulin Infusion treatment in patients with drug naive type 2 diabetes.

研究设计

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

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • for type 2 diabetes:
  • Male or female age ≧ 25 years and ≦75 years old
  • HbA1c ≧8.0%
  • for normal controls:
  • Male or female age ≧ 25 years and ≦75 years old
  • Normal glucose tolerance confirmed by oral glucose tolerance test

排除标准

  • Islet antibody positive
  • Athletes, has a history of skeletal muscle injury ( trauma or surgery ), skeletal muscle wasting diseases ( such as mitochondrial myopathy, muscular atrophy, etc )
  • Acute infection(such as cute upper respiratory infection, acute pneumonia)
  • long-term use of non-steroidal anti-inflammatory drugs, corticosteroids and immunosuppressive drugs
  • consists with other endocrine diseases
  • use of antibiotics in 3 months
  • chronic digestive inflammations
  • magnetic resonance imaging contraindications

研究组 & 干预措施

Type 2 Diabetes

drug naive Type 2 Diabetes received insulin therapy

干预措施: Insulin (Drug)

结局指标

主要结局

Circulating immunity cell profiles

时间窗: 7 days

profiles of circulating immunity cells such as T cells

次要结局

  • skeletal muscle parameter(7 days)

研究者

发起方
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dalong Zhu

Doctor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

研究点 (2)

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