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Understanding the utilisation of protein in a restricted carbohydrate environment in Type 1 diabetes

Understanding the utilisation of dietary protein in type 1 diabetes patients on a restricted carbohydrate diet - developing a tool for protein counting.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614001150639
Acronym
none
Enrollment
16
Registered
2014-10-30
Start date
2016-09-05
Completion date
2017-08-02
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

This exploratory study aims to understand the relationship between protein and insulin requirements in differing carbohydrate environments in participants with type 1 diabetes. The hypothesis: once habituated to a low carbohydrate diet, an insulin bolus for protein intake is required to maintain glycaemic control, due to gluconeogenesis from protein. The starting point for this bolus is that it will be twice the carbohydrate to insulin ratio. For example, if a patient uses a ratio of 1 unit insulin to 10g carbohydrate, they will use 1 unit to 20g protein.

Interventions

The hypothesis: once habituated to a low carbohydrate diet (75g carbohydrate per day for 4 weeks), an insulin bolus for protein intake is required to maintain glycaemic control, due to gluconeogenesis from protein. The starting point for this bolus is that it will be twice the carbohydrate to insulin ratio. For example, if a patient uses a ratio of 1 unit insulin to 10g carbohydrate, they will use 1 unit to 20g protein. To test this each participant (habituated to a low carbohydrate diet) will u

The hypothesis: once habituated to a low carbohydrate diet (75g carbohydrate per day for 4 weeks), an insulin bolus for protein intake is required to maintain glycaemic control, due to gluconeogenesis from protein. The starting point for this bolus is that it will be twice the carbohydrate to insulin ratio. For example, if a patient uses a ratio of 1 unit insulin to 10g carbohydrate, they will use 1 unit to 20g protein. To test this each participant (habituated to a low carbohydrate diet) will undergo 6 meal tests/. The intervention meal tests are meal tests 4-6 (identical): 40g protein + 8g carbs from a protein shake and giving a bolus for carbohydrate and protein. Participants will have baseline glucose checked before starting the meal test, if blood glucose is outside of 4-8mmol then test will be postponed. Meal and insulin bolus will be administered at time 0, blood will be taken at 10, 20, 30, 60, 90, 120, 150, 180 mins. Washout period between meal tests will be 48 hrs.

Sponsors

Capital and Coast District Health Board
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

Type 1 diabetes mellitus on a basal/bolus insulin regimen Good understanding of carbohydrate counting and insulin ratios

Exclusion criteria

Pregnant or breastfeeding women Unstable glycaemic control – HbA1c greater than or equal to 85 Renal failure - eGFR greater than or equal to 30mls/min or urinary macroalbumin:creatinine greater than or equal to 30 Use of an insulin pump

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026