PD-LOOP study
Research type
Research Study
Full title
Early identification of Pre-diabetes and evaluation of Lifestyle Therapy in Children and Adolescents with Obesity using Continuous Glucose Monitoring System
IRAS ID
304419
Contact name
Senthil Senniappan
Contact email
Sponsor organisation
Alder Hey Children's Hospital
Duration of Study in the UK
1 years, 0 months, 11 days
Research summary
Background:
Childhood obesity is a worldwide public health concern with rates continuing to rise. Obesity has a huge impact on an individual’s overall health and wellbeing, due to complications such as type 2 diabetes mellitus (T2DM). T2DM is a widely recognised condition in the adult population, but sadly this issue is increasingly common in childhood and has its own serious complications. The association between childhood obesity and progression to T2DM is both a medical and public health concern.Aim:
The aim of our project is to investigate glucose variation using continuous glucose monitoring (CGM) devices in children and young people with obesity.Why?
Pre-diabetes is an under-recognised condition, which is diagnosed when glucose levels are above the normal range, but not high enough for a formal diagnosis of T2DM. It is a known predictor for developing T2DM. Therefore, if glucose dysregulation can be identified earlier and lifestyle modifications are beneficial, it may prevent commencing medications and requiring long-term treatment.Design:
This is a pilot study at one tertiary paediatric hospital to gather preliminary data and show the feasibility of conducting a full-scale trial. 50 participants aged 8-18 years, body mass index >98th percentile, recent oral glucose tolerance test (OGTT), and do not meet the exclusion criteria will be considered.
Participants will be asked to attend the site for baseline fasting bloods, measurements, and completion of questionnaires. A CGM and ActivPal will be inserted for 10 days to obtain free-living data. The participant will then commence a 12-week lifestyle intervention, with two weekly reviews. They will return to the site post-intervention for repeat bloods, OGTT, measurements and questionnaires. The CGM and ActivPal will be inserted again for a further 10 days.
Comparison between fasting bloods, biomarkers, measurements, questionnaires, OGTT, CGM and ActivPal results pre- and post-intervention will be analysed.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
21/NE/0235
Date of REC Opinion
19 Jan 2022
REC opinion
Further Information Favourable Opinion