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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02903615




Registration number
NCT02903615
Ethics application status
Date submitted
5/06/2016
Date registered
16/09/2016
Date last updated
22/03/2022

Titles & IDs
Public title
Optimising Health in Type 1 Diabetes
Scientific title
The Optimal Diet for Optimising Health in Type 1 Diabetes
Secondary ID [1] 0 0
16/053
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Novel diet
Other interventions - Standard diet

Experimental: Novel type 1 diet - Experimental diet to be examined: altered macronutrient composition: lower carbohydrate, Mediterranean-style, prebiotic fibre focus.

Placebo Comparator: Standard therapy - Standard dietary therapy, as promulgated by Australian standards


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

Other interventions: Standard diet
Standard diabetes diet recommendations
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Glucose control
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
Inflammation
Timepoint [1] 0 0
3 months
Secondary outcome [2] 0 0
Gut microbiome
Timepoint [2] 0 0
3 months
Secondary outcome [3] 0 0
C-peptide
Timepoint [3] 0 0
3 months
Secondary outcome [4] 0 0
postprandial glucose excursion
Timepoint [4] 0 0
3 months
Secondary outcome [5] 0 0
Follow-up of glycemic control and insulin secretion
Timepoint [5] 0 0
12 and 24 months

Eligibility
Key inclusion criteria
- type 1 diabetes
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Women lactating, pregnant or of childbearing potential who are not willing to avoid
becoming pregnant during the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2020
Sample size
Target
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
professor Katherine Samaras - Sydney
Recruitment hospital [2] 0 0
Garvan Institute to Medical Research - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Garvan Institute of Medical Research
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT02903615
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Katherine Samaras, MD PhD FRACP
Address 0 0
Garvan Institute of Medical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02903615