Optimising Health in Type 1 Diabetes

NCT ID: NCT02903615

Last Updated: 2022-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2020-06-30

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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Novel type 1 diet

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

Group Type EXPERIMENTAL

Novel diet

Intervention Type OTHER

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

Standard therapy

Standard dietary therapy, as promulgated by Australian standards

Group Type PLACEBO_COMPARATOR

Standard diet

Intervention Type OTHER

Standard diabetes diet recommendations

Interventions

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Novel diet

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

Intervention Type OTHER

Standard diet

Standard diabetes diet recommendations

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Garvan Institute of Medical Research

OTHER

Sponsor Role lead

Responsible Party

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Professor Katherine Samaras

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katherine Samaras, MD PhD FRACP

Role: PRINCIPAL_INVESTIGATOR

Garvan Institute of Medical Research

Locations

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professor Katherine Samaras

Sydney, New South Wales, Australia

Site Status

Garvan Institute to Medical Research

Sydney, , Australia

Site Status

Countries

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Australia

Other Identifiers

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16/053

Identifier Type: -

Identifier Source: org_study_id

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