Optimising Health in Type 1 Diabetes
The Optimal Diet for Optimising Health in Type 1 Diabetes
1 other identifier
interventional
13
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus
Started Sep 2016
Longer than P75 for not_applicable diabetes-mellitus
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedFirst Posted
Study publicly available on registry
September 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedMarch 22, 2022
April 1, 2020
3.8 years
June 5, 2016
March 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glucose control
HbA1c
3 months
Secondary Outcomes (5)
Inflammation
3 months
Gut microbiome
3 months
C-peptide
3 months
postprandial glucose excursion
3 months
Follow-up of glycemic control and insulin secretion
12 and 24 months
Study Arms (2)
Novel type 1 diet
EXPERIMENTALExperimental diet to be examined: altered macronutrient composition: lower carbohydrate, Mediterranean-style, prebiotic fibre focus.
Standard therapy
PLACEBO COMPARATORStandard dietary therapy, as promulgated by Australian standards
Interventions
Novel diet to optimise glucose levels and minimise systemic inflammation: altered macronutrient composition: lower carbohydrate, Mediterranean-style, prebiotic fibre focus.
Eligibility Criteria
You may qualify if:
- type 1 diabetes
You may not qualify if:
- Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
professor Katherine Samaras
Sydney, New South Wales, 2010, Australia
Garvan Institute to Medical Research
Sydney, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katherine Samaras, MD PhD FRACP
Garvan Institute of Medical Research
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 5, 2016
First Posted
September 16, 2016
Study Start
September 1, 2016
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
March 22, 2022
Record last verified: 2020-04