KurCoSmart Effects on People With Type 2 DM: a Randomized, Open Trial
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Blood glucose
研究概览
简要总结
The investigators aim to evaluate the effect of curcumin and virgin coconut oil extract supplementation on people with type 2 DM, including blood glucose, HbA1c levels, inflammation, body weight and insulin resistance evaluation
详细描述
The investigators give Kurcosmart supplementation aside from diabetes standard treatment to evaluate its benefits on people with type 2 DM, considering its effect on controlling fasting and prandial blood glucose, reducing HbA1c level, controlling inflammation degree; and repairing insulin resistance
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed Type 2 DM
- •Signing consent form
排除标准
- •Pregnant or breastfeeding
- •Multiple organ failure
- •History of hypersensitivity reaction to curcumin and virgin coconut oil
- •Cancer, renal insufficiency, hematological disease, acute heart failure, chronic liver disease
结局指标
主要结局
Blood glucose
时间窗: Change of Blood glucose at 1 months
Subject's fasting and prandial blood glucose
insulin resistance
时间窗: Change of HOMA IR at 1 Months
Subject's HOMA IR
HbA1c
时间窗: Change of HbA1C at 1 Months
Subject's glycated haemoglobin level
Inflammation degree
时间窗: Change of hs-CRP at 1 Months
Subject's high sensitivity C-reactive protein level
次要结局
- Body Mass Index(Change of BMI at 1 Months)
- Blood Pressure(Change fof blood prssure at 1 Months)
研究者
Nurhasan Agung Prabowo
M.D.
Universitas Sebelas Maret