Glucose response to a formula for patients at risk of hypoglycaemia - EFFECT

utricia Research0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年4月9日

试验速览

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•1. Healthy individuals, 18 up to and including 50 years of age.
•2. Willing to maintain habitual diet, physical activity pattern, and body
•weight throughout the trial.
•3. Willing to avoid the consumption of alcohol, unusual food intake, unusual
•physical activity 24h prior to each study visit.
•4. 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).

•1. Abnormal blood glucose levels at screening (not fasted) in the opinion of
•the investigator.
•2. 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.
•3. 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.
•4. Use of medications known to influence gastric emptying (including but not
•limited to anticholinergics, nicotine, narcotic analgesics, ganglion blocking
•drugs, antacids and metoclopramide).
•5. Use of anti-clotting medications.
•6. 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).
•7. Self-reported pregnancy or breastfeeding.

发起方

utricia Research