NCT05676385已完成不适用
Glucose Response to a Formula for Patients at Risk of Hypoglycaemia
Nutricia Research1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2023年2月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Decline in glucose level after reaching peak (Cmax)
研究概览
简要总结
This study assesses the glycemic responses to several nutritional products.
详细描述
During a study visit fasted subjects will consume one serving of the reference product or of the test products. Venous blood samples will be taken at baseline and at several time-points over a 6-hr period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals, 18 up to and including 50 years of age.
- •Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
- •Willing to avoid the consumption of alcohol, unusual food intake, unusual physical activity 24h prior to each study visit.
- •Willing to come to the study visit in the morning after an overnight fast of minimum 10 hours and maximum 14 hours (with water only).
排除标准
- •Blood glucose levels ≥ 7.8 mmol/L at screening (not fasted)
- •Known history of gastrointestinal disease (e.g., diverticulitis, Crohn's disease, coeliac disease etc.), bariatric surgery, AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), or any condition which might, in the opinion of the Principal Investigator either: 1) make participation dangerous to the subject (e.g. anaemia) or to others, or 2) affect the results.
- •Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or any medication which might, in the opinion of the Principal Investigator either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
- •Use of medications known to influence gastric emptying (including but not limited to anticholinergics, nicotine, narcotic analgesics, ganglion blocking drugs, antacids and metoclopramide).
- •Use of anti-clotting medications.
- •Current tobacco smokers or smokers that quite smoking < 1 month prior to screening (except for occasional (≤ 3) cigarettes/cigars/pipes per week on average over the past month).
- •Self-reported pregnancy or breastfeeding
结局指标
主要结局
Decline in glucose level after reaching peak (Cmax)
时间窗: 6 hours
The decline in glucose (mmol/hour) after reaching peak glucose levels (Cmax) until reaching baseline (t = -5) blood glucose levels or, in case baseline blood glucose levels are not reached, the lowest observed blood glucose level.
次要结局
- Incremental Area Under the Curve (iAUC) for glucose(6 hours)
- Incremental Area Under the Curve (iAUC) for insulin(6 hours)
- Incremental peak levels (iCmax) of insulin(6 hours)
- Incremental peak levels (iCmax) of paracetamol(6 hours)
- Incremental Area Under the Curve (iAUC) for paracetamol(6 hours)
- Incremental peak levels (iCmax) of glucose(6 hours)
- Time to peak levels (Tmax) of glucose(6 hours)
- Time to peak levels (Tmax) of insulin(6 hours)
- Time to peak levels (Tmax) of paracetamol(6 hours)
研究者
研究点 (1)
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