NCT05143827Unknown不适用
Glycemic Index of Pasta From Traditional and Current Wheat Varieties in Patients With Type 2 Diabetes: a Randomized, Cross-over, Blind Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- 60-min glucose
研究概览
简要总结
This randomized, cross-over study compares pasta produced with three different wheat varieties (Senatore Cappelli, Korasan, Claudio). Patients with type 2 diabetes with no pharmacological treatment will be randomized to three different sequences, and asked to eat a standard portion of pasta on three different occasions, four days apart. 3-hour post-prandial interstitial glucose profiles will be recorded using trans-cutaneous sensors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
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 2 diabetes
- •Body Mass Index (BMI) > 20 kg/m2
- •HbA1c < 58 mmol/mol
排除标准
- •Current pharmacological therapy for diabetes (of any kind)
- •Pregnancy or lactation
结局指标
主要结局
60-min glucose
时间窗: 60 minutes
Glucose (interstitial monitoring) 60 min after beginning of meal
次要结局
- 30-min glucose(30 minutes)
- 90-min glucose(90 minutes)
- AUC glucose 180 min(180 minutes)
- 120-min glucose(120 minutes)
- Area Under the Curve (AUC) glucose 30 min(30 minutes)
- AUC glucose 60 min(60 minutes)
- AUC glucose 90 min(90 minutes)
- AUC glucose 120 min(120 minutes)
- 150-min glucose(150 minutes)
- 180-min glucose(180 minutes)
研究者
Edoardo Mannucci
Director, Diabetology unit
Azienda Ospedaliero-Universitaria Careggi
研究点 (2)
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