A Randomized, double-blind, parallel, placebo-controlled, interventional Study to Evaluate the Effect of Test/placebo biscuits in Regulating Blood Glucose and Safety in Pre-diabetic Subjects

ITC Life Sciences and Technology Center0 个研究点目标入组 150 人开始时间: 待定最近更新: 2021年11月24日

研究概览

暂无简介。

•1. Males and females greater than or equal to 18 and less than or equal to 65 years of age
•2. Body mass index of greater than or equal to 18.5 and less than or equal to 30 kg per m2
•3. Pre-diabetic subjects with fasting blood glucose between 100 and 125 mg/dL (called impaired
•fasting glucose or IFG), IGT (greater than or equal to 140 and less than 200), and HbA1c levels greater than or equal to 5.7% and less than or equal to 6.4%
•4. Subjects willing to comply with diet control
•5. Subjects with history of stable weight, defined as no significant weight change (less than Â±5%)
•within three months prior to enrollment
•6. If on anti-hypertensive therapy, the dosage must be constant for at least 2 months prior to the
•screening visit, based on medical history.
•7. Females of child-bearing potential and males should be willing to use adequate methods of
•contraception.
•8. Must be willing to give written informed consent and comply with the study procedures.

•1. Type 1 or type 2 diabetes mellitus
•2. Subject with lipid abnormalities or thyroid disorders
•3. Pregnant or lactating women
•4. Subjects requiring a fibre free diet
•5. Subject requiring enteral tube feed or parenteral nutrition
•6. Diagnosed with an eating disorder such as bulimia or binge eating
•7. Any acute gastrointestinal disease within 2 weeks prior to study entry
•8. History of Cancer
•9. Clinically significant cardiac disease or endocrine abnormalities
•10. Suspicion of drug abuse, abuse of/addiction to alcohol
•11. Untreated major psychiatric disorder
•12. History of bariatric surgery
•13. Known HIV positive
•14. Serum creatinine of greater than or equal to 1.5 mg per dL
•15. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values greater than or equal to 2.5 X Upper Limit of Normal (ULN)

发起方

ITC Life Sciences and Technology Center