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What is the Dose Response of Varying Meal Content of Fat on Postprandial Glycaemia in Children With T1DM?

NCT02371694 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-08-20

No results posted yet for this study

Summary

Background: Based on international evidence, current management of people with T1DM on intensive insulin therapy (IIT) use algorithms based on the meal carbohydrate content (MCC) to calculate the prandial insulin dose. Typically, these calculations do not take into account the protein or fat content of the meal. There is a lack of clinical advice for optimal management of high protein/fat meals due to a paucity of evidence regarding the impact of protein/fat on glycaemic control.

Objective: To determine the mean glucose excursion from fasting (measured by continuous glucose monitoring, CGMS) at each 30 minute interval over the 8 hour postprandial period for each test condition. Protein effects will be looked at in a separate parallel study in Australia.

Hypothesis: The fat content of a meal will cause a dose-response change in the postprandial glucose concentration in children with T1DM.

Research Design and Methods: Randomised cross-over study involving thirty patients. Inclusion criteria: T1DM \>1 year, aged 8-18 years, with HbA1c \<8% and BMI \<91st centile, on intensive insulin therapy. Participants will be given a test meal on 6 consecutive nights in random order; 4 test meals varying in fat content, and one 20g carbohydrate test meal with zero fat given as control meal. A CGMS will be used to assess glucose responses at 5 minute intervals for 8 hours after test meal consumption. The relationship between the fat loads in the test meals and the mean change in postprandial glucose concentration will be analysed and described.

Conclusions: This study will determine whether fat causes dose dependent response in glucose concentrations leading to refining the guidelines and possible adjustment of insulin doses for the fat content of a meal.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

OTHER

Test drink

The intervention is a drink taken 4 hours after the evening meal insulin injection, or 10PM, whichever is later. All drinks are 116-120g in weight and similar volume. All drinks are served in a double blind fashion, apart from the 20g carbohydrate which is visibly different from other drinks in colour, texture and flavour.

Sponsors & Collaborators

  • National University of Ireland, Galway, Ireland

    collaborator OTHER

  • John Hunter Children's Hospital

    collaborator OTHER

  • Cork University Hospital

    lead OTHER

Principal Investigators

  • Susan O'Connell, MD · Cork University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2018-12-30
Completion
2018-12-30

Countries

  • Ireland

Study Locations

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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 NCT02371694 on ClinicalTrials.gov