NCT06970834尚未招募不适用
Using Continuous Glucose Monitoring Tools to Explore the Effect of Bitter Melon Peptides on Glycemic Control and Metabolic Indicators in Diabetic Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 主要终点
- glycemic variability
研究概览
简要总结
The goal of this clinical trial is to learn the potential of bitter melon peptides in stabilizing blood glucose in diabetic adults. It will also learn about the effects of bitter melon peptides on metabolic parameters. The main questions it aims to answer are:
- the regulatory effects of bitter melon peptides on glycemic variability
- impact on glycemic and metabolic indicators Researchers will compare bitter melon peptides to a placebo (a look-alike capsule that contains Microcrystalline Cellulose) to see if bitter melon peptides works to stabilizing blood glucose.
Participants will:
- Take bitter melon peptides or a placebo every day for 12 weeks
- Visit the clinic on day 0, day 7, day 28 and day 84 for checkups and tests
- Glucose levels were monitored continuously by CGMs in the first 7 days and fasting blood samples were drawn at first visit (day0), third visit (day 28) and fourth visits (day 84)
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants were diagnosed with type 2 DM based on criteria recommended by the American Diabetes Association and required to have fasting plasma glucose of ≥126 mg/dl or an HbA1c of
- •≥ 6.5%, as measured on two separate occasions
排除标准
- •cancer, active liver disease, current pregnancy , acute illness and autoimmune thyroid disease.
结局指标
主要结局
glycemic variability
时间窗: From enrollment (day0) to day7
mean amplitude of glucose excursions and coefficient of variation, using CGM
次要结局
- glycemic control(From enrollment (day0) to the end (day84))
研究者
PEI-YUNG LIAO
Chief of Division of Endocrinology and Metabolism, Department of Internal Medicine
Changhua Christian Hospital
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