MedTrace Logo

Effect of Food Composition on Postprandial Insulin Secretion in Neonatal Diabetes

NCT02921906 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-10-31

No results posted yet for this study

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.

Conditions

  • Neonatal Diabetes

Interventions

OTHER

High protein meal

Breakfast with high protein / low carbohydrate content

OTHER

High carbohydrate meal

Breakfast with high carbohydrate / low protein content

DRUG

Paracetamol

Standard dose of paracetamol administered with each meal to allow measurement of rate of gastric emptying.

OTHER

Fasting state - sulphonylurea only

People with diabetes take sulphonylurea medication in the absence of any food stimulus

Sponsors & Collaborators

  • Royal Devon and Exeter NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Andrew T Hattersley, BMBCh DM FRS · University of Exeter

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2022-06-20
Completion
2022-06-20

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02921906 on ClinicalTrials.gov