Autoimmune Diabetes Accelerator Prevention Trial (adAPT) - adAPT

niversity of Exeter0 个研究点目标入组 90 人开始时间: 2015年9月28日最近更新: 2020年7月27日

试验速览

暂无简介。

•FOR SCREENING PHASE (approx. ~3500)
•-Children/Adolescents aged 5-16 years at time of screening who are siblings of people whose T1D developed before the age of 25 years
•-Children/Adolescents aged 5-16 years who are the offspring of parents who themselves developed T1D before the age of 25 years
•-Parent/Participant is willing and able to give informed consent/assent
•-Multiple family members meeting eligibility criteria.
•FOR RCT PHASE (~ n= 90-200)
•- Children/adolescents identified by screening to be sero-positive for at least two of the four islet-related antibodies (IAA, GAD, IA-2, ZnT8).
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 90
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•For Screening Phase:
•-Parent /Participant is unwilling/unable to give informed consent/assent
•-Under 5y or over 16y at time of screening
•-Sibling or child of person who developed T1D after the age of 25y
•-Known to have physician diagnosed diabetes
•-Already taking metformin
•-Physically or psychologically unable to participate
•-Taking medication likely to increase insulin resistance (e.g. oral/systemic steroids or growth hormone)
•-Contraindication to metformin – anoxia, cardiovascular insufficiency, renal or hepatic disease, sepsis
•-Participating in another clinical trial (other than observational trials and registries) concurrently or within 30 days prior to screening for entry into this study
•Additional exclusions for RCT Phase:
•-Development of diabetes during the screening phase
•-Identified by screening to be sero-negative (fewer than two of the four islet-related antibodies (IAA, GAD, IA-2, ZnT8)
•-Pregnant or lactating
•-Known allergies to milk and soya
•For Randomisation:
•-fasting blood glucose (laboratory sample) greater than or equal to 7mmol/L

发起方

niversity of Exeter