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Do blood glucose levels after meals relate to gut hormones, stomach emptying, and nervous system function in young people with type 1 diabetes?

Incretin release, gastric emptying and post prandial glycaemia in type 1 diabetes and the relationship with autonomic dysfunction.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12612000619842
Enrollment
30
Registered
2012-06-08
Start date
2013-04-03
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Gut emptying is of central importance to blood glucose levels after meals and is a major determinant of overall blood glucose control in diabetes. Blood glucose levels and insulin release after meals are also influenced by secretion of hormones from the gut in response to a meal. The gut hormones stimulate insulin secretion in response to raised blood glucose levels. However fat, rather than carbohydrate may be the most potent stimulus for gut hormone release. We aim to measure the effect of gut emptying and gut hormone release on high blood glucose levels in youth with type 1 diabetes (T1D). Gut hormone based therapy may normalize gut emptying and/or suppress hormones therefore reducing high blood glucose levels after meals in youth with T1D. Hypothesis: In young people with type 1 diabetes (i) Gut emptying is slower than in controls (ii) Gut hormone secretion is normal in comparison to controls (iii) Nervous system dysfunction relates to gut emptying

Interventions

Subjects with type 1 diabetes (T1D) will have 1 study day, on which they will consume a standard pancake at approximately 8.30am, after fasting from both solids and liquids from 10pm the previous evening. There should be no risk to subjects fasting from 10pm. If they develop hypoglycaemia they should manage it with the standard treatment (ie. Glucose tablets). Morning insulin will not be given until they are at the hospital and have commenced the study. All T1D subjects will have duration of T1D

Subjects with type 1 diabetes (T1D) will have 1 study day, on which they will consume a standard pancake at approximately 8.30am, after fasting from both solids and liquids from 10pm the previous evening. There should be no risk to subjects fasting from 10pm. If they develop hypoglycaemia they should manage it with the standard treatment (ie. Glucose tablets). Morning insulin will not be given until they are at the hospital and have commenced the study. All T1D subjects will have duration of T1D and HbA1c at the time of the study recorded. Insulin administration T1D subjects will administer their ultrashort insulin analog (novorapid) immediately before the ingestion of the meal at time -15minutes, via subcutaneous injection or an insulin pump. The dose of ultrashort insulin analog for the standard pancake will be calculated for each subject according to their prescribed carbohydrate ratio (units of insulin/grams of carbohydrate). This is usually 2-3 units per 15g of carbohydrate. Pancake Each subject will consume the pancake within 5min and t = 0 is defined as the time of meal completion. The standard pancake (70g of Green’s (Trademark) Pancake and Pikelet Mix mixed with 100mL water and cooked with 10g butter; total of 13.5 g fat, 44.2g of carbohydrate, 252 calories) will be given to the T1D subjects. After consuming the pancake T1D subjects will undergo a gastric emptying breath test and measurement of incretin hormones over 4 hours. An ECG recording over 20 minutes using AD Instruments PowerLab system (Amsterdam, Holland) will measure (i) mean resting heart rate (HR) and HR variability parameters (ii) standard deviation of adjacent QRS complexes (iii) mean square root of successive QRS intervals, an estimate of overall HR variability (iv) lower:higher frequency ratio: an estimate of sympathetic/parasympathetic balance.

Sponsors

University of Adelaide
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
10 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

Duration of T1D greater than 1 year

Exclusion criteria

Previous gastrointestinal surgery (apart from uncomplicated appendicectomy), requirement for medications that could affect gastrointestinal motility (eg erythromycin, SSRIs), pregnancy or lactation.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026