Diabetes MellitusNCT02903615
Optimising Health in Type 1 Diabetes
A study testing Novel diet and Standard diet in people with Diabetes Mellitus, run by Garvan Institute of Medical Research at 2 sites in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Novel diet and Standard diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 2 sitesAustralia
- Study dates
- Sep 2016to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- type 1 diabetes
Who cannot join
- Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
professor Katherine Samaras
Sydney, New South Wales, 2010
Garvan Institute to Medical Research
Sydney
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Novel diet, Standard diet
- Keywords
- glucose, inflammation
- Medical subject headings
- Diabetes Mellitus, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel dietOther
Novel diet to optimise glucose levels and minimise systemic inflammation: altered macronutrient composition: lower carbohydrate, Mediterranean-style, prebiotic fibre focus.
Standard dietOther
Standard diabetes diet recommendations
| Study group | Role | What they receive |
|---|---|---|
| Novel type 1 diet | Experimental | Experimental diet to be examined: altered macronutrient composition: lower carbohydrate, Mediterranean-style, prebiotic fibre focus. Receives: Other: Novel diet |
| Standard therapy | Placebo comparator | Standard dietary therapy, as promulgated by Australian standards Receives: Other: Standard diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose control
HbA1c
Measured: 3 months
Secondary outcomes (5)
Inflammation
Circulating immune cells numbers
Measured: 3 months
Gut microbiome
Gut flora subtypes
Measured: 3 months
C-peptide
Urinary excretion
Measured: 3 months
postprandial glucose excursion
postprandial glucose excursion
Measured: 3 months
Follow-up of glycemic control and insulin secretion
HbA1c, urinary C-peptide
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Garvan Institute of Medical Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Katherine Samaras, Garvan Institute of Medical Research
- Investigators
- Katherine Samaras, MD PhD FRACP, Principal investigator, Garvan Institute of Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02903615
- Sponsor's protocol ID
- 16/053
- Status last verified
- Apr 2020
- First submitted
- 5 Jun 2016
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Diet for Optimising Health in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02903615
- Acronym / sponsor ID
- 16/053
- Conditions
- Diabetes Mellitus
- Keywords
- glucose, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Garvan Institute of Medical ResearchUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novel type 1 diet | Experimental | Other: Novel dietExperimental diet to be examined: altered macronutrient composition: lower carbohydrate, Mediterranean-style, prebiotic fibre focus. |
| Standard therapy | Placebo comparator | Other: Standard dietStandard dietary therapy, as promulgated by Australian standards |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- type 1 diabetes
Key exclusion criteria (1 listed)
- Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel dietNovel diet to optimise glucose levels and minimise systemic inflammation: altered macronutrient composition: lower carbohydrate, Mediterranean-style, prebiotic fibre focus. | Other | Novel type 1 diet |
| Standard dietStandard diabetes diet recommendations | Other | Standard therapy |
Primary outcome
Glucose control
Time frame: 3 months
HbA1c
5 secondary outcomes
Inflammation
Time frame: 3 months
Gut microbiome
Time frame: 3 months
C-peptide
Time frame: 3 months
postprandial glucose excursion
Time frame: 3 months
Follow-up of glycemic control and insulin secretion
Time frame: 12 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Samaras, MD PhD FRACP principal investigator
Garvan Institute of Medical Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel diet and Standard diet in people with Diabetes Mellitus, run by Garvan Institute of Medical Research at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose control (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.