adAPT
Research type
Research Study
Full title
Autoimmune Diabetes Accelerator Prevention Trial (adAPT) - Screening & Stage 1
IRAS ID
174798
Contact name
Rob Andrews
Contact email
Eudract number
2015-000748-41
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
adAPT aims to find out whether metformin, an oral hypoglycaemic agent, can reduce insulin demand in children at risk of type 1 diabetes (T1D) and prevent disease. The study is built around the benefits of reducing beta cell demand, so that lower blood glucose levels and lower insulin levels (lower HOMA-IR) are key outcome measures of response to the intervention.
The first phase of adAPT will screen participants aged 5-16years for diabetes antibody status of siblings or offspring diagnosed with T1D before the age of 25years in Scotland and England. Screening requires a non-fasting blood sample.
There are four principle antibodies associated with T1D. The presence of two or more confers a 40% risk of developing T1D in five years. While the presence none or one antibody carries a risk for developing T1D similar to the general population (1 in 500 in 5 years).
It is anticipated that 3-5% of those screened will be indentified as double-antibody positive, these participants will be invited to join the RCT. Up to 200 eligible subjects could be identified by screening: a minimum of 90 will be enrolled.
The RCT has three stages: Stage 1 involves 4 months treatment with metformin/placebo, however this will run seamlessly into Stage 2. Stage 1&2 participation will last up to 36 months (participants enrolled earliest will have the longest intervention). During the Stage 1 during 4 months intervention, participants will be tested on three occasions (baseline, month 1 and month 4) for metabolic response using a 5-point mixed meal tolerance test (MMTT). Testing will continue in Stage 2 with 6 visits on months 8,12,18,24,30 & 36. Peripheral blood monocytes and DNA will be archived on each occasion for later immunological and genetic analysis.REC name
East of Scotland Research Ethics Service REC 2
REC reference
15/ES/0075
Date of REC Opinion
9 Jul 2015
REC opinion
Further Information Favourable Opinion