Optimising Health in Type 1 Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Other: Novel diet; Other: Standard diet

• Registration Number: NCT02903615
• Lead Sponsor: Garvan Institute of Medical Research

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-06-05
• Study Start: 2016-09
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-16
• Status Verified: 2020-04
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Last Update Submitted: 2022-03-20
• Last Update Posted: 2022-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Novel type 1 diet	Novel diet	Experimental diet to be examined: altered macronutrient composition: lower carbohydrate, Mediterranean-style, prebiotic fibre focus.
Standard therapy	Standard diet	Standard dietary therapy, as promulgated by Australian standards

Primary Outcome Measures

Name	Time	Method
Glucose control	3 months	HbA1c

Secondary Outcome Measures

Name	Time	Method
Inflammation	3 months	Circulating immune cells numbers
Gut microbiome	3 months	Gut flora subtypes
postprandial glucose excursion	3 months	postprandial glucose excursion
C-peptide	3 months	Urinary excretion
Follow-up of glycemic control and insulin secretion	12 and 24 months	HbA1c, urinary C-peptide

Trial Locations

Locations (2)

Garvan Institute to Medical Research; 🇦🇺 Sydney, Australia

professor Katherine Samaras; 🇦🇺 Sydney, New South Wales, Australia