Optimising Health in Type 1 Diabetes

Garvan Institute of Medical Research

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Other: Standard diet; Other: Novel diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02903615

16/053

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups, including a placebo group

Novel type 1 diet

Experimental group

Description:

Experimental diet to be examined: altered macronutrient composition: lower carbohydrate, Mediterranean-style, prebiotic fibre focus.

Treatment:

Other: Novel diet

Standard therapy

Placebo Comparator group

Description:

Standard dietary therapy, as promulgated by Australian standards

Treatment:

Other: Standard diet