DRKS00026093已完成未知
Clinical dose-finding study to assess the effect of ABAlifeTM on postprandial blood glucose profile in prediabetic subjects: randomized, multicentric, double-blind, placebo-controlled, cross-over study with different dosages combined with a 12-weeks follow-up phase - BTS1462/19
Anton Hübner GmbH & Co. KG0 个研究点目标入组 61 人开始时间: 2021年8月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 61
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Male and female subjects (minimum one third of each gender) with prediabetic HbA1c values between 5.7% and 6.4% and/or fasting glucose = 5.6 mmol/L (= 100 mg/dL) and < 7.0 mmol/L (< 125 mg/dL) (in venous plasma) (twice confirmed at two independent days if HbA1c is < 5.7%)
- •Body mass index 19-35 kg/m2
- •Current Non-smoker
- •Availability and presence in the study units for approx. 3.5 hours/ week for 2 times (Visit 1 and Visit 2) and approx. 4.5 hours/ week for 2 times (Visit 3 and Visit 5).
- •Signed informed consent form
- •No changes in food habits or physical activity 3 months prior to screening and during the study
- •If applicable, stable intake of chronic medication of at least 4 weeks
排除标准
- •Subjects with diagnosed Type 2 Diabetes mellitus with medical treatment
- •Presence of disease or drug(s) influencing digestion and absorption of nutrients
- •Intake of medications known to affect glucose tolerance, e.g., diabetic medication, SGLT-2 inhibitors, GLP-1 receptor agonists, steroids, protease inhibitors or antipsychotics
- •Chronic intake of substances affecting blood coagulation (e.g. acetylic acid (100 mg as standard prophylactic treatment allowed when dose is stable 1 month prior to screening), anticoagulants, diuretics, thiazides (diuretics and thiazides allowed e.g. for hypertension treatment when dose is stable 1 month prior to screening)), which in the Investigator’s opinion would impact patient safety
- •Severe liver or renal disease (e.g. CKD stage =4) or laboratory evidence of hepatic dysfunction (i.e. alkaline phosphatase, ALT, AST >3 x ULN)
- •Known inflammatory or malignant gastrointestinal diseases (i.e. colitis ulcerosa, Morbus Crohn, celiac disease, malignant diseases e.g. colon-cancer, rectum cancer, pancreatitis)
- •Clinically relevant findings as established by medical history, physical examination, clinical laboratory and/or vital signs
- •Major medical or surgical event requiring hospitalization within the previous 3 months
- •Intake of food supplements known to affect glucose tolerance, e.g., cinnamon capsules, conjugated linoleic acids
- •Intake of antibiotics within 4 weeks before the test days
- •Drug-, alcohol- and medication abuses
- •Pregnant or breast-feeding women
- •Weight loss intervention or recent body weight change >5 kg during last 3 months
- •Diet high in vegetables and fruits =5 portions per day
- •Vegan lifestyle
- •Known or suspected allergy to any component of the investigational product(s) (e.g. figs)
- •Blood donation within 4 weeks prior to Visit 1 or during the study
- •Anticipating any planned changes in lifestyle for the duration of the study
- •Participation in another clinical intervention study within the last 4 weeks and concurrent participation in another intervention clinical study
- •Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol
研究者
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