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NCT Number: NCT02903615

Optimising Health in Type 1 Diabetes

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Inflammation Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

professor Katherine Samaras, Sydney, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Novel diet

Other

Novel diet to optimise glucose levels and minimise systemic inflammation: altered macronutrient composition: lower carbohydrate, Mediterranean-style, prebiotic fibre focus.

Standard Diet

Other

Standard diabetes diet recommendations

Primary outcomes

  1. Glucose control

    Time frame: 3 months

    HbA1c

Secondary outcomes

  1. Inflammation

    Time frame: 3 months

    Circulating immune cells numbers

  2. Gut microbiome

    Time frame: 3 months

    Gut flora subtypes

  3. C-peptide

    Time frame: 3 months

    Urinary excretion

  4. postprandial glucose excursion

    Time frame: 3 months

    postprandial glucose excursion

  5. Follow-up of glycemic control and insulin secretion

    Time frame: 12 and 24 months

    HbA1c, urinary C-peptide

Sponsors and collaborators

Lead sponsor

Garvan Institute of Medical Research

Other

Registry information

Official study title

The Optimal Diet for Optimising Health in Type 1 Diabetes

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 16, 2016
Registry last updated
Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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