Association Between Natural Hypoglycemic Foods and Blood Sugar Level: A Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 124
- 主要终点
- Decrease of ≥ 0.5mmol/L in FPG
研究概览
简要总结
Type 2 diabetes patients often do not reach desired control of glycemia despite guidance on changing lifestyle and diet as well as the use of conventional anti-diabetic medication. Parallely in recent years, an array of comparative clinical studies have demonstrated the anti-diabetic effect of more than 10 common spices and food products. Objectives: to evaluate whether proposing a choice of spices and foods products with hypoglycemic effect to diabetic patients can help better control diabetes.
详细描述
Diabetic type II patients would be encouraged to eat what they like within a list of food products with hypoglycemic effect, at a similar dosage and preparation mode than the one in the reference clinical trials.
This pilot project will be conducted as a randomized controlled trial with 2 arms over 12 weeks: 1. training patients about hypoglycemic spices and foods alongside their usual anti-diabetic treatment, versus usual anti-diabetic treatment alone.
Expected results: Confirmation of the hypothesis that daily consuming spices and foods with hypoglycemic effect to diabetic patients can help better control 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes patients with poorly controlled glycemia, i.e. at least one of the following measurements:
- •Fasting plasma glucose (FPG) values ≥ 7.0 mmol/L (126 mg/dl), or 2-h post-load plasma glucose ≥ 11.1 mmol/L (200 mg/dl), or HbA1c > 6.5% (48 mmol/mol); or a random blood glucose ≥ 11.1 mmol/L (200 mg/ dl), despite ≥ 3 months usual care (lifestyle + medication if applicable).
排除标准
- •Severe and unstable complications of diabetes: end-organ damage such as nephropathy, retinopathy, neuropathy, etc...
- •Patients with rapid insulin,
- •Any health condition that requires urgent attention,
- •Patients with a cognitive or sensory impairment that may prevent conducting the interview,
- •HbA1c > 11.5%
- •Pregnant women
结局指标
主要结局
Decrease of ≥ 0.5mmol/L in FPG
时间窗: 12 weeks
Percentage of patients in each group reaching a decrease of ≥ 0.5mmol/L in FPG over 12 weeks
Decrease of ≥ 0.5 points of percentage of HbA1c
时间窗: 12 weeks
Percentage of patients in each group reaching a decrease of ≥ 0.5 points of percentage from the baseline value in HbA1c over 12 weeks
次要结局
- Weight(12 weeks)
- Mean change of FPG(12 weeks)
- Target glycemia(12 weeks)
- Mean change of HbA1c(12 weeks)
- Blood pressure(12 weeks)