The Effect of Metformin as add-on to Insulin in Non-obese Patients With Autoimmune Diabetes
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Mean amplitude of glycemic excursions (MAGE)
研究概览
简要总结
The objective of this study is to evaluate the therapeutic effect of metformin as additional treatment with insulin on non-obese autoimmune diabetes.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes according to ADA criterias <5 years.
- •Age≥ 18 years and less than 70 years.
- •Non-obese: defined as BMI less than 28 kg/m2
- •Positive for at least one of the anti-islet autoantibodies: GADA, IA2A, ZnT8A
- •Fasting or postprandial plasma C-peptide more than 100 pmol/L
- •Written informed consent from the patient or family representative.
排除标准
- •History of any malignancy or other severe diseases
- •Female patients who are pregnant or breastfeeding before or during the three-year follow-up
- •Poor compliance or refusal to participate.
研究组 & 干预措施
Metformin + Insulin
干预措施: Metformin (Drug)
Metformin + Insulin
干预措施: Insulin (Drug)
Insulin alone
干预措施: Insulin (Drug)
结局指标
主要结局
Mean amplitude of glycemic excursions (MAGE)
时间窗: 6 months
MAGE is measured by applying continuous glucose monitoring system (CGMS) on subjects in each follow-up of this 6-month study.
Change in C-peptide
时间窗: 6 months
C-peptide are measured before and 2-hour after a mixed meal tolerance test at each follow-up of this study.
次要结局
- Change in HbA1c(6 months)
- Change in daily insulin dose(6 months)
- Change in body mass index (BMI)(6 months)
- Change in lipid profiles(6 months)
- Adverse effects(6 months)
研究者
Zhiguang Zhou
Director, Department of Endocrinology, Institute of Metabolism and Endocrinology, National Clinical Research Center for Metabolic Diseases, Second Xiangya Hospital, Central South University
Second Xiangya Hospital of Central South University