- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02903615
Optimising Health in Type 1 Diabetes
The Optimal Diet for 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Sydney, Australia
- Garvan Institute to Medical Research
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New South Wales
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Sydney, New South Wales, Australia, 2010
- professor Katherine Samaras
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Novel type 1 diet
Experimental diet to be examined: altered macronutrient composition: lower carbohydrate, Mediterranean-style, prebiotic fibre focus.
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Novel diet to optimise glucose levels and minimise systemic inflammation: altered macronutrient composition: lower carbohydrate, Mediterranean-style, prebiotic fibre focus.
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Placebo Comparator: Standard therapy
Standard dietary therapy, as promulgated by Australian standards
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Standard diabetes diet recommendations
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose control
Time Frame: 3 months
|
HbA1c
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inflammation
Time Frame: 3 months
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Circulating immune cells numbers
|
3 months
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Gut microbiome
Time Frame: 3 months
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Gut flora subtypes
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3 months
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C-peptide
Time Frame: 3 months
|
Urinary excretion
|
3 months
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postprandial glucose excursion
Time Frame: 3 months
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postprandial glucose excursion
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3 months
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Follow-up of glycemic control and insulin secretion
Time Frame: 12 and 24 months
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HbA1c, urinary C-peptide
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12 and 24 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Katherine Samaras, MD PhD FRACP, Garvan Institute of Medical Research
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16/053
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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