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Dietary proteins influence on post meal insulin requirements in young people with type 1 diabetes.

Effect of high protein meal on the insulin dose required to maintain post-prandial euglycaemia, in youth (12-21 years) with type 1 diabetes.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615001127594
Enrollment
11
Registered
2015-10-26
Start date
2015-01-30
Completion date
2016-01-07
Last updated
2021-10-26

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

Conditions

None listed

Brief summary

Clinical experience and reports from families of children with type 1 diabetes has long suggested that meals high in protein and/or fat cause an increase in blood glucose levels after eating. Increased blood glucose levels, including after consumption of food, is well-known to add to long term health complications in type 1 diabetes. Current type 1 diabetes management guidelines recommend adjusting insulin doses for food based on the amount of carbohydrate to be eaten at each meal. However, there has been an increase in evidence, including that from a recent study by our study group, to suggest that other nutrients such as fat and protein should be considered when calculating pre meal insulin. High levels of protein and/or fat in a meal cause a larger than expected rise in blood glucose levels after eating and these high blood glucose levels persist, suggesting the need for extra insulin. This research project will compare the insulin required to maintain blood glucose levels at a constant level when consuming two meals, one high in protein and the other low in protein. This will be determined by looking at the difference in intra venous insulin requirements after both meals. IV insulin will be given to participants to maintain blood glucose levels at a constant level whilst they are eating the meal and in the 5 hours following. Fifteen participants will consume both a high protein and a low protein meal, at least one week apart. The different insulin amounts needed to maintain blood glucose levels after each test meal will provide accurate calculation of the expected increase in insulin requirements on consumption of a high protein meal. This study will provide important information in the management of type 1 diabetes in both adults and children. This information will be used immediately in our day to day management of patients and will guide the development of clinical guidelines to minimize the rise in blood glucose levels after eating.

Interventions

The intervention involves the provision of a meal high in protein. The high protein meal contains 30grams of carbohydrate, 60g protein and < 10g of fat. There is a minimum of 1 week between the intervention and control meal. From the commencement of meal consumption, IV insulin will be titrated in response to the glucose excursions to keep BGL at a target of 5.0mmol.

Sponsors

Princess Margaret Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
12 Years to 21 Years
Healthy volunteers
No

Inclusion criteria

Type 1 diabetes > 1 year HbA1c < /= 8% Intesive insulin therapy > 6 months BMI < /= 97th percentile

Exclusion criteria

pre-existing diabetes complications co-existing medical conditions

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026