NCT03982238已完成4 期
Effects of Continuous Subcutaneous Insulin Infusion and Oral Hypoglycemic Drugs on Testosterone Levels in Type 2 Diabetes Patients
Majianhua1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2019年6月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- total testosterone levels
研究概览
简要总结
The study will assess the total testosterone and sex hormone-binding globulin levels in men with type 2 diabetes before and after continuous subcutaneous insulin infusion and hypoglycemic drugs treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •volunteer to participate and be able to sign informed consent prior to the trial.
- •patients with type 2 diabetes, aged 18-60 years old, meeting WHO1999 diagnostic criteria, have not used any hypoglycemic drugs.
- •HbA1c > 9%.
- •subjects are able and willing to eat and exercise regularly.
排除标准
- •patients with insulin allergy.
- •impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal.● drug abuse and alcohol dependence in the past 5 years.
- •systemic hormone therapy was used in the last three months.
- •patients with poor compliance and irregular diet and exercise.
- •patients with infection and stress within 4 weeks.
- •any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.
研究组 & 干预措施
Control group
Active Comparator
continuous subcutaneous insulin infusion therapy
干预措施: Insulin (Drug)
Metformin
Experimental
metformin therapy
干预措施: Metformin (Drug)
Dapagliflozin
Experimental
Dapagliflozin
干预措施: Dapagliflozin (Drug)
结局指标
主要结局
total testosterone levels
时间窗: 1 month
changes of total testosterone levels
次要结局
- bioavailable testosterone(1 month)
- free testosterone(1 month)
研究者
Majianhua
Director, Head of Endocrinology department, Clinical Professor
Nanjing First Hospital, Nanjing Medical University
研究点 (1)
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