ACTRN12621001527853
Recruiting
未知
Specialised Dietary Fibre Intervention in Children with Type 1 Diabetes - is it safe, feasible and tolerable?
Queensland Children's Hospital0 sites30 target enrollmentStarted: November 10, 2021Last updated:
Overview
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Queensland Children's Hospital
- Enrollment
- 30
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 5 Years to 14 Years (—)
- Sex
- All
Inclusion Criteria
- •Children and adolescents aged 5 – 14 years (inclusive) with T1D that was diagnosed at least 3 months prior to entry into the study
- •\- HbA1c less than or equal to 9% (75 mmol/mol) at the time of entry into the study
- •\- BMI between 15th centile and 85th centile, inclusive
- •\- The child/adolescent and their family are willing and able to follow the study protocol
Exclusion Criteria
- •\- Concomitant disease or treatment that may, in the judgement of the investigators, impact on glycaemic control, insulin requirements or other outcome measures
- •\- Hypoglycaemia unawareness
- •\- History or symptoms of malabsorption or gastrointestinal disease, including coeliac disease
- •\- Known liver or renal disease
- •\- On a restricted or special diet that would impact their ability to take the supplement e.g. intermittent fasting or ketogenic diet
- •\- Use of medication other than insulin that affects glucose homeostasis
- •\- Antibiotic usage within the six weeks prior to entry into the study or anticipated usage during the study
Investigators
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