Effect of Food Composition on Postprandial Insulin Secretion in Neonatal Diabetes

• Status: Unknown status
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

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. Some patients report low glucose after meals and we think this may be because they make too much insulin if they eat a meal with protein but low amounts of carbohydrate. The investigators will test this by giving study participants different meals and measuring the amount of insulin, glucose and incretin hormone in the blood afterwards.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Royal Devon and Exeter NHS Foundation Trust
• Treatments: Acetaminophen; Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Age ≥8yrs.

• Willing and able to provide informed consent (adults i.e. participants aged >16 years).

• Willing and able to provide assent and parents willing to provide informed consent (children and young people <16 years).

Exclusion Criteria:

• Age <8yrs.

• Unable/unwilling to provide informed consent (adults).

• Unable/unwilling to provide assent (children) or parents unwilling to provide informed consent.

• Known liver disease or chronic renal impairment (EGFR <60ml/min).