Optimising Health in Type 1 Diabetes

Diabetes Mellitus Clinical Trial

Official title:

The Optimal Diet for Optimising Health in Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02903615
• Other study ID #: 16/053
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: June 30, 2020

Study information

• Verified date: April 2020
• Source: Garvan Institute of Medical Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Australia	Garvan Institute to Medical Research	Sydney
Australia	professor Katherine Samaras	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Garvan Institute of Medical Research

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose control	HbA1c	3 months
Secondary	Inflammation	Circulating immune cells numbers	3 months
Secondary	Gut microbiome	Gut flora subtypes	3 months
Secondary	C-peptide	Urinary excretion	3 months
Secondary	postprandial glucose excursion	postprandial glucose excursion	3 months
Secondary	Follow-up of glycemic control and insulin secretion	HbA1c, urinary C-peptide	12 and 24 months