The Breakfast Rise, Education and Knowledge Study (BREAK)
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ClinicalTrials.gov Identifier: NCT05698875 |
Recruitment Status :
Not yet recruiting
First Posted : January 26, 2023
Last Update Posted : January 26, 2023
|
Sponsor:
University of Stirling
Information provided by (Responsible Party):
University of Stirling
Brief Summary:
The study proposes to recruit 90 children and young people who have type 1 diabetes (T1D) and who regularly use Dexcom continuous glucose monitoring (CGM). The participants will be recruited from National Health Service (NHS) sites in the United Kingdom (UK) via their managing dietitian. The dietitian will be asked to provide baseline information about the participants which will include demographic data and information on clinical data, treatment and anthropometrics. Participants will be asked to provide access to Dexcom CGM data throughout the period of recording. Participants will be asked to test three breakfast meals (high glycaemic load, high glycaemic with 10g added protein and medium glycaemic load) plus a control meal (usual breakfast), repeating each meal twice in a randomized order using a Latin square randomisation. The dietitian will be asked to optimise the participants insulin doses prior to commencing test meals. Participants will be asked to complete a questionnaire for each of the postprandial test and control meal periods. This will include questions about their diabetes management, food and fluid intake in addition to questions on activities all of which took place during the three-hour postprandial period. The glycaemic response to the test and control meals will be analysed using the CGM data and the results statistically described using univariate, bivariate and multivariate analysis.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
type1diabetes | Other: High glycaemic load breakfast meal Other: High glycaemic load breakfast meal with additional 10g protein Other: Medium glycaemic load breakfast meal | Not Applicable |
Show detailed description
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 90 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | Participants will be randomised to test each of the three test meals on two separate occasions with a control meal (usual breakfast meal) for each test meal. Randomisation will be achieved using a Latin square randomisation. The tool used for this will be http://www.jerrydallal.com/random/randomize.htm. Randomisation will be done in a block of four. |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | The Breakfast Rise, Education and Knowledge Study in Children and Young People Who Have Type 1 Diabetes (T1D): The BREAK Study |
Estimated Study Start Date : | February 2023 |
Estimated Primary Completion Date : | December 2023 |
Estimated Study Completion Date : | August 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Type 1 diabetes
MedlinePlus related topics:
Diabetes Type 1
Arm | Intervention/treatment |
---|---|
Test meal 1
High glycaemic load breakfast meal
|
Other: High glycaemic load breakfast meal
Breakfast meal |
Test meal 2
High glycaemic lead with additional 10g protein breakfast meal
|
Other: High glycaemic load breakfast meal with additional 10g protein
Breakfast meal |
Test meal 3
Medium glycaemic load breakfast meal
|
Other: Medium glycaemic load breakfast meal
Breakfast meal |
Primary Outcome Measures :
- Mean glucose (mmol/l) [ Time Frame: three-hour postprandial breakfast period ]mmol/l
Secondary Outcome Measures :
- Mean peak glucose [ Time Frame: three-hour postprandial breakfast period ]mmol/l
- Mean time to peak [ Time Frame: three-hour postprandial breakfast period ]minutes
- Mean time to recover [ Time Frame: three-hour postprandial breakfast period ]minutes
- Area under the glucose curve [ Time Frame: three-hour postprandial breakfast period ]mmol/minute
- Range times (Time in range, time above range, time below range) [ Time Frame: three-hour postprandial breakfast period ]Percentage
Information from the National Library of Medicine
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Ages Eligible for Study: | 5 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Children and young people aged between 5-17 years
- Diagnosis of type 1 diabetes for a minimum of one year
- On multiple daily injections (MDI) together with carbohydrate counting or Continuous Subcutaneous Insulin Infusion (CSII) using either open or closed loop systems.
- Use Dexcom continuous glucose monitoring (CGM) on a regular basis
- Have a Dexcom Clarity account and use the Clarity App
- Regularly eats a breakfast meal before midday
- Access to internet and email
Exclusion Criteria:
- Prescribed anti-hyperglycaemia agents i.e. Glucophage (Metformin) and or antidepressants.
- Any other medical conditions that may impact on the digestion and or absorption of nutrients, including coeliac disease and gastroparesis.
- Vegans
- Allergic or intolerant to the test meals
- Experiencing difficulties with food including diagnosed eating disorders
- Currently actively taking part in another research study
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05698875
Contacts
Contact: Julie Johnson, MNutr | 07815893076 | julie.johnson1@stir.ac.uk | |
Contact: Stuart DR Galloway, PhD | 01786 466494 | s.d.r.galloway@stir.ac.uk |
Locations
United Kingdom | |
Faculty of Health Sciences and Sport | |
Stirling, Stirlingshire, United Kingdom, FK9 4LA | |
Contact: Julie Johnson, MNutr 07815893076 julie.johnson1@stir.ac.uk | |
Contact: Stuart DR Galloway, PhD 01786 466494 s.d.r.galloway@stir.ac.uk |
Sponsors and Collaborators
University of Stirling
Investigators
Principal Investigator: | Julie Johnson, MNutr | University of Stirling |
Publications:
Responsible Party: | University of Stirling |
ClinicalTrials.gov Identifier: | NCT05698875 |
Other Study ID Numbers: |
316676 |
First Posted: | January 26, 2023 Key Record Dates |
Last Update Posted: | January 26, 2023 |
Last Verified: | December 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Diabetes Mellitus, Type 1 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |