The Effect of Whey Protein Consumption on Hypoglycemia in Adults with Type 1 Diabetes During the Fasting Holy Month of Ramadan: a Randomized, Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Hypoglycemia incidence rate
研究概览
简要总结
Cross over randomized design for adding whey protein to Suhoor meal for patients with T1DM during fasting Ramadan
详细描述
Patients with type1 diabetes who intend to fast will be supplied with dietary supplement "Whey protein" to be taken with Suhoor (predawn meal) for one week during Ramadan. They will be then crossed over to not taking the whey protein for another week. the order of taking whey protein will be randomized.
During both weeks patients will be monitored through flash continuous glucose monitoring and data will be compared in regards to incidence and timing of hypoglycemia, hyperglycemia, and time in target range.
After Ramadan data will be collected on number of days they had to brake fast due to low blood sugar during both weeks and overall satisfaction with using whey protein during Ramadan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 Diabetes Mellitus
- •Age >14 years
- •Committed to do Regular SMBG or on CGM
- •On Multiple Daily Injections or insulin pumps
- •On carbohydrate counting for meal dosing
- •Have previously fasted Ramadan
- •willing to fast Ramadan this year
- •Well-educated about requirements for fasting Ramadan
排除标准
- •Hypoglycemia unawareness
- •Cognitive impairment or learning disability
- •Renal and hepatic impairment
- •Adrenal insufficiency
- •Alcohol consumption
- •Any diagnosed psychiatric disease
- •Sensor-augmented insulin pumps
- •HbA1c >12%
- •Already on protein supplements
结局指标
主要结局
Hypoglycemia incidence rate
时间窗: 1 month
number of hypoglycemic events (blood glucose \<70mg/dl) as detected by flash glucose monitoring
次要结局
- Percentage Time-below-range (TBR), time-above-range (TAR), and time-in-range (TIR) prior to and following whey protein consumption 2.(1 month)
- Glycemic control (HbA1c) and GMI during protein consumption(1 month)
- number of days they needed to brake the fast during each week(1 month)
- Patient preferences through questionnaire(1 month)