Clinical study to assess the long-term effect of a mixture ofplant extracts on glucose homeostasis in prediabetic subjects: a 12-week randomized, double-blind, placebo-controlled, parallel study

APOMEDICA Pharmazeutische Produkte GmbH0 个研究点目标入组 42 人开始时间: 2024年4月15日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Main inclusion criteria:
•- Male and female subjects with prediabetic HbA1c values between 5.7% – 6.4% and/or fasting glucose = 5.6 mmol/L (= 100 mg/dL) and = 6.9 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
•- 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

•Main Exlusion criteria:
•- 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
•- Known inflammatory and malignant gastrointestinal diseases (i.e. colitis ulcerosa, Morbus Crohn, celiac disease, malignant diseases e.g. colon-cancer, rectum cancer, pancreatitis)
•- 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 or laboratory evidence of hepatic dysfunction (i.e. alkaline phosphatase, ALT, AST >3 x ULN)
•- Acute gastrointestinal diseases including diarrhea and/or vomiting within the last 2 weeks
•- Clinically relevant findings as established by medical history, physical examination, clinical laboratory and/or vital signs
•- Intake of food supplements known to affect glucose tolerance, e.g. cinnamon capsules, conjugated linoleic acids within 4 weeks prior to Visit 1 or during the study

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