Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000241730
Ethics application status
Approved
Date submitted
25/01/2022
Date registered
10/02/2022
Date last updated
21/02/2023
Date data sharing statement initially provided
10/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Fasting for Type 2 Diabetes Mellitus (T2DM) Remission
Scientific title
A cohort study to evaluate the effect of alternate day fasting (ADF) on endogenous insulin secretion and insulin sensitivity in adults with Type 2 diabetes mellitus
Secondary ID [1] 305799 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes mellitus 324305 0
Condition category
Condition code
Metabolic and Endocrine 321795 321795 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will be active in the study for approximately a 2-week period, visiting a study site (University of Canterbury or GP health clinic) a minimum of two times.

Participant interventions include:
- Prior to starting the active 2-week period, the participants will attend a 2-hour information seminar to learn about how fasting will affect insulin requirements, how to manage during fasting periods, and what to eat when not fasting. The seminar will be jointly delivered by the study team including a practicing General Practitioner (GP), a Health Coach with a BAppSc Human Nutrition, and scientific researcher (MSc). The group size will be 10 -12 people in a face-to-face format. Participants will also receive handouts including tips for fasting, do’s and don’ts, planning worksheets, and some recipe ideas. The handouts are designed specifically for this study with some material based, in part, on “The Complete Guide to Fasting” by Jason Fung.
- Participants will have a 1-hour personal meeting with the Health Coach to discuss and create a personal plan.
- Participants will have 15-minute phone check-ins with the GP or Health Coach on the 6 fasting days to support participation in the trial.
- The participants will be asked to observe 6 fasting periods, each lasting up to 24 hours. Fasting periods are scheduled to start on days 2, 4, 6, 8, 10, and 12 with 24 hr periods of normal eating between each fasting period.
Intervention code [1] 322195 0
Treatment: Other
Intervention code [2] 322196 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329559 0
Insulin secretion will be determined using C-peptide concentration in blood samples taken during the Dynamic Insulin Sensitivity and Secretion Test (DISST).
Timepoint [1] 329559 0
Outcome measured at start of intervention and ~14 days after intervention starts.
Primary outcome [2] 329584 0
Insulin sensitivity will be determined using a physiological mathematical model and blood samples taken during the Dynamic Insulin Sensitivity and Secretion Tests (DISSTs).
Timepoint [2] 329584 0
Outcome measured at start of intervention and ~14 days after intervention starts.
Primary outcome [3] 329585 0
Insulin required during non-fasting days will be determined by self-report from the participants via questionnaires designed specifically for this study.
Timepoint [3] 329585 0
Outcome measured at start of intervention and ~14 days after intervention starts.
Secondary outcome [1] 403105 0
Weight change assessed using digital standing scales.
Timepoint [1] 403105 0
Outcome measured at start of intervention and ~14 days after intervention starts.
Secondary outcome [2] 405724 0
Markers of oxidative stress assessed by analysis of blood samples.
Timepoint [2] 405724 0
Outcome measured at start of intervention and ~14 days after intervention starts.
Secondary outcome [3] 405725 0
Insulin mediated glucose uptake (IMGU) and non-insulin mediated glucose uptake (NIMGU) determined from a physiological mathematical model and blood samples taken during the Dynamic Insulin Sensitivity and Secretion Tests (DISSTs).
Timepoint [3] 405725 0
Outcome measured at start of intervention and ~14 days after intervention starts.

Eligibility
Key inclusion criteria
Age 18 -70 years
Type 2 Diabetes Mellitus
Currently use insulin to control blood sugar
Ability to give informed consent
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Breastfeeding women
Medication contraindications
Ischemic Heart Disease (IHD)
Moderate to severe Chronic Kidney Disease (CKD)
Uncontrolled diabetes
Currently taking SGLT2 inhibitor
Diagnosed eating disorder
Malnourishment

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/04/2022
Actual
15/06/2022
Date of last participant enrolment
Anticipated
15/06/2023
Actual
Date of last data collection
Anticipated
15/07/2023
Actual
Sample size
Target
10
Accrual to date
3
Final
Recruitment outside Australia
Country [1] 24327 0
New Zealand
State/province [1] 24327 0
Canterbury

Funding & Sponsors
Funding source category [1] 310151 0
Government body
Name [1] 310151 0
Ministry of Business, Innovation, and Employment; New Zealand National Science Challenge: Science for Technology & Innovation Challenge [#CRS-53-2019]
Country [1] 310151 0
New Zealand
Primary sponsor type
Individual
Name
Dist. Prof. J. Geoffrey Chase
Address
Level 5 Civil/Mechanical Building
University of Canterbury
Private Bag 4800
Christchurch 8140
New Zealand
Country
New Zealand
Secondary sponsor category [1] 311226 0
Individual
Name [1] 311226 0
Dr. Pedram Zawarreza
Address [1] 311226 0
WeCare Health Wigram
67 Skyhawk Road
Wigram
Christchurch 8042
New Zealand
Country [1] 311226 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309840 0
Southern Health and Disability Ethics Committee (HDEC)
Ethics committee address [1] 309840 0
Ethics committee country [1] 309840 0
New Zealand
Date submitted for ethics approval [1] 309840 0
26/01/2022
Approval date [1] 309840 0
12/04/2022
Ethics approval number [1] 309840 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115566 0
Dr Pedram Zawarreza
Address 115566 0
WeCare Health Wigram
67 Skyhawk Road
Wigram
Christchurch 8042
New Zealand
Country 115566 0
New Zealand
Phone 115566 0
+64 210 242 4159
Fax 115566 0
Email 115566 0
[email protected]
Contact person for public queries
Name 115567 0
Pedram Zawarreza
Address 115567 0
WeCare Health
67 Skyhawk Road
Wigram
Christchurch 8042
New Zealand
Country 115567 0
New Zealand
Phone 115567 0
+64 33498613
Fax 115567 0
Email 115567 0
[email protected]
Contact person for scientific queries
Name 115568 0
Geoff Chase
Address 115568 0
Level 5 Civil/Mech Building
University of Canterbury
Private Bag 4800
Christchurch, 8140
New Zealand
Country 115568 0
New Zealand
Phone 115568 0
+64 33692182
Fax 115568 0
Email 115568 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data from insulin sensitivity test and calculated insulin sensitivity.
When will data be available (start and end dates)?
Data will be available from completion of the study to at least 3 years after publication.
Available to whom?
De-identified data will be available on request. They must provide a suitable analysis and data management plan.
Available for what types of analyses?
Insulin sensitivity and insulin secretion data will be available for meta-analyses.
How or where can data be obtained?
De-identified data can be obtained by request by emailing the study sponsor [email protected].


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14124Study protocol  [email protected] Study protocol can be obtained by request from the... [More Details]
14125Ethical approval  [email protected] Ethics approval can be obtained by request from th... [More Details]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.