NCT06512090尚未招募不适用
To Investigate the Effects of Low Glycemic Index（LGI）Related Steamed Bread on Glycemia Control, Islet Function in Patients With Type 2 Diabetes in China: A Single-center, Randomized, Open-label, Prospective Study
Shanghai Punan Hospital of Pudong New District0 个研究点目标入组 144 人开始时间: 2024年7月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 144
- 主要终点
- glucose at 120 mins
研究概览
简要总结
This was a single-center, randomized, open, prospective, parallel-controlled, head-to-head comparison trial. To investigate the effects of low glycemic index（LGI）related steam bread on glycemic control，islet function in patients with type 2 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
- •Age ≥18yrs；
- •Diagnosed as Type 2 Diabetes;
- •Had been on a stable hypoglycemic regimen for at least 30 days prior to screening；
- •HbA1c between 7.5% and 11.0% (both upper and lower limits included) in the 90 days prior to screening;
- •Fasting C-peptide ≥1.0ng/ml in the 90 days prior to screening;
- •Be willing to accept and adhere to LGI steamed bread as a staple food for at least 14 days
排除标准
- •Diagnosed with type 1 diabetes, or secondary diabetes;
- •Have clinically significant liver disease, moderate/severe kidney injury, or end-stage renal disease;
- •Has unstable CV disorders, including heart failure (NYHA) class III or IV), intractable angina, uncontrolled arrhythmias, and severe uncontrolled hypertension (systolic blood pressure ≥180mmHg, or diastolic blood pressure ≥105mmHg);
- •An Acute Coronary Syndrome event (ACS) occurred within the 6 months prior to randomization
结局指标
主要结局
glucose at 120 mins
时间窗: 120 minutes
the blood glucose level at 120 mins after Standard meal test
次要结局
- iAUC 120 minutes(120 minutes)
- glucose at 60 mins(60 minutes)
研究者
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