FoND Study V1
Research type
Research Study
Full title
The effect of food on insulin secretion in neonatal diabetes.
IRAS ID
205255
Contact name
Andrew Hattersley
Contact email
Sponsor organisation
R&D Department, RD&E NHS Foundation Trust
Duration of Study in the UK
2 years, 2 months, 31 days
Research summary
Neonatal diabetes is diagnosed before 6 months of age and causes high blood glucose levels due to the pancreas not secreting insulin. Neonatal diabetes can be caused by a change in a DNA region called the KCNJ11 gene. KCNJ11 encodes a channel in the pancreas that acts as a switch to turn 'on' and 'off' insulin secretion. A change in KCNJ11 results in a faulty channel, which keeps insulin secretion 'switched off'. The diabetes can be treated with tablets called sulphonylureas that switch the pancreatic channel 'on', allowing it to secrete insulin in response to gut hormones called incretins. Previous research has shown that patients who switch from insulin to sulphonylureas have better blood glucose control, including fewer episodes of hypoglycaemia (glucose dropping too low), and also avoid the need for injections. It is thought that serious side effects from sulphonylureas are uncommon in KCNJ11 neonatal diabetes and hypoglycaemia, if it occurs, is mild and self-limiting but may be related to the type of food the patient eats. These questions need to be formally studied. We wish to study how the type of food that patients eat affects the pancreatic channel when the sulphonylurea has switched it 'on', by giving patients different meals and measuring the amount of insulin, glucose and other hormones in the blood afterwards.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
16/SW/0150
Date of REC Opinion
3 Jun 2016
REC opinion
Further Information Favourable Opinion