Optimising Health in Type 1 Diabetes

Study Overview
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Brief Summary
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Type 1 diabetes is an autoimmune condition where circulating immune cells destroy the beta-cells in the pancreas that make insulin, resulting in a degree of insulin deficiency, whereby blood glucose levels rise and diabetes develops. When there is severe insulin deficiency, life-threatening ketoacidosis can develop. Treatment is lifelong insulin replacement therapy; dietary intervention is a also cornerstone of glucose management. The Optimise Diet is a multi-pronged diet based on best health principles: to minimise blood glucose rises after eating, reduce the immune cells involved in destruction of the insulin-secreting beta-cells, and improve the gut microbiome and systemic inflammation. In this study, its effects will be compared to the Standard Diabetes Diet that is currently recommended in Australia and internationally.

Detailed Description
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The rationale for this study is to determine whether a diet based on recent scientific advances in diet-induced inflammation, will improve diabetes care in people with type 1 diabetes.

Official Title
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The Optimal Diet for Optimising Health in Type 1 Diabetes

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Other: Novel diet
* Other: Standard diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 1 diabetes Exclusion Criteria: Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Novel type 1 diet<br>Experimental diet to be examined: altered macronutrient composition: lower carbohydrate, Mediterranean-style, prebiotic fibre focus. | Other: Novel diet<br>* Novel diet to optimise glucose levels and minimise systemic inflammation: altered macronutrient composition: lower carbohydrate, Mediterranean-style, prebiotic fibre focus.<br>|
| Placebo Comparator: Standard therapy<br>Standard dietary therapy, as promulgated by Australian standards | Other: Standard diet<br>* Standard diabetes diet recommendations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose control | HbA1c | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation | Circulating immune cells numbers | 3 months | 
| Gut microbiome | Gut flora subtypes | 3 months | 
| C-peptide | Urinary excretion | 3 months | 
| postprandial glucose excursion | postprandial glucose excursion | 3 months | 
| Follow-up of glycemic control and insulin secretion | HbA1c, urinary C-peptide | 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glucose, inflammation