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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novel type 1 diet | Experimental | Experimental diet to be examined: altered macronutrient composition: lower carbohydrate, Mediterranean-style, prebiotic fibre focus. |
|
| Standard therapy | Placebo Comparator | Standard dietary therapy, as promulgated by Australian standards |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel diet | Other | Novel diet to optimise glucose levels and minimise systemic inflammation: altered macronutrient composition: lower carbohydrate, Mediterranean-style, prebiotic fibre focus. |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose control | HbA1c | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation | Circulating immune cells numbers | 3 months |
| Gut microbiome | Gut flora subtypes | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Samaras, MD PhD FRACP | Garvan Institute of Medical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| professor Katherine Samaras | Sydney | New South Wales | 2010 | Australia | ||
| Garvan Institute to Medical Research |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Standard diet | Other | Standard diabetes diet recommendations |
|
| 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 |
| Sydney |
| Australia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |