Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000001897
Ethics application status
Approved
Date submitted
17/08/2020
Date registered
7/01/2021
Date last updated
7/01/2021
Date data sharing statement initially provided
7/01/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Characterising the Pre-diabetic Asian and Caucasian Phenotype: the ‘TOFI’ Profile – 3-year Follow-up
Scientific title
Characterising the Pre-diabetic Asian and Caucasian Phenotype: the ‘TOFI’ Profile – 3-year Follow-up: identifying biomarkers of diabetic susceptibility and resilience using a metabolomics platform
Secondary ID [1] 300823 0
Nil
Universal Trial Number (UTN)
U1111-1249-9953
Trial acronym
TOFI_F/U
Linked study record
This is a 3-year follow up study to ACTRN12616000362493

Health condition
Health condition(s) or problem(s) studied:
Diabetes 316713 0
Condition category
Condition code
Diet and Nutrition 314954 314954 0 0
Obesity
Metabolic and Endocrine 314955 314955 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The cross-sectional TOFI Asia study recruited Asian Chinese and European Caucasian adults resident in 2016 in Auckland, New Zealand. Participants were across a wide range of age (18-70 years), body weight, BMI (body-mass index (BMI) between 20-45 kg/m2) and glycaemia; with both normoglycaemic and moderately hyperglycaemic (pre-diabetic) included. Current or prior diagnosis of type 2 diabetes (T2D) was an exclusion criterion. The cohorts were matched for gender, age and BMI. Phenotype characteristics were measured once in the fasted state and these included anthropometry, body composition including whole body, visceral and ectopic organ fat, and clinical blood biomarkers related to T2D risk, in addition to serum metabolomics and faecal microbiome. The anticipated duration of the assessments is approximately 2 hours

In order to determine whether these markers may predict who worsens towards and/or develops diabetes, longitudinal follow up will be conducted. The 3-year follow-up study will measure anthropometry and fasted blood samples once in the fasted state. Participants will also have once dual-energy x-ray absorptiometry (DXA) scan to determine total and regional body fat, and collect a stool/faecal sample, for gut microbiome.

100 female participants, due to gender differences in body composition, will additionally undertake a single Magnetic Resonance Imaging and Spectroscopy (MRI/S) scan, to determine ectopic and/or non-adipose tissue organ fat in pancreas and liver. They will also complete a short sub-maximal cardiorespiratory fitness (CRF) test. The MRI/S scan will take about 40 minutes to complete.
A subset of these women (n=25) who additionally also had their MRI/S scan will be invited to have a single intravenous glucose tolerance test (ivGTT) as a measure of insulin secretion in the fasted state. The test will take 1 hour and will involve

Will also recruit a new cohort of Asian Chinese and Caucasian participants, to the study, who will undergo baseline testing (as done in 2016 for the TOFI_Asia participants) and subsequent 3 year follow-up in 2023-24. All new participants will meet the following criteria: Asian (mainland Chinese; Hong Kong, Taiwan, Singapore or Malaysian Chinese; or Korean) or Caucasian European ethnicity, aged 18-70 years old, normal weight or overweight with a body mass index (BMI=weight/height2) of between 20-50kg/m2, but are otherwise healthy.
Participants will be matched for gender, age and BMI. Phenotype characteristics that will be measured will include anthropometry, body composition and clinical blood biomarkers related to T2D risk, in addition to serum metabolomics and faecal microbiome.
Intervention code [1] 317154 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323265 0
Characterise the healthy vs prediabetic profile for type 2 diabetes based on blood biomarkers (including established biomarkers i.e., fasting plasma glucose, insulin, HbA1c, full lipid profile, liver function tests and novel metabolomic biomarkers) and body composition (using DeXA and MRI/S). This is a composite primary outcome of both blood biomarkers and body composition.
Timepoint [1] 323265 0
3 years post-enrolment
Primary outcome [2] 323266 0
Analysis of pancreas and liver fat deposition using untargeted LC-MS methodology in a subgroup of 100 female participants.
Timepoint [2] 323266 0
3 years post-enrolment
Primary outcome [3] 326128 0
Identify novel plasma metabolomic markers, that are predictive of pancreas and liver fat deposition and risk of developing type 2 diabetes in a subgroup of 100 female participants.
Timepoint [3] 326128 0
3 years post-enrolment
Secondary outcome [1] 381376 0
Determine the impact of MRI determined pancreas and liver fat on pancreatic beta-cell function and insulin secretion using an intravenous glucose tolerance test (iVGTT) in a subgroup of 25.
Timepoint [1] 381376 0
3 years post-enrolment.
2-stepped 30-minute tests with blood samples collected at -10, 0, 2, 4, 6, 10,25, 30, 32, 34, 36, 40, 55 and 60 minutes for iVGTT.
Secondary outcome [2] 381377 0
Determine cardiorespiratory fitness as assessed by the YMCA cycle ergometer submaximal test in 100 women.
Timepoint [2] 381377 0
3 years post-enrolment.
Steady-state heart rate (SSHR) will be calculated as an average HR recorded during the 2nd and 3rd minute of each stage of the YMCA Cycle Ergometer Submaximal Exercise Test.

Eligibility
Key inclusion criteria
Participants of both gender,
(i) between 18–70 years
(ii) BMI 20–45 kg/m2
(iii) both parents of the same ethnic origin, either European Caucasian or Asian Chinese (including mainland China, Singapore, Malaysia, Hong Kong, Taiwan, and Korea)
(iv) normo- or dysglycaemic (fasting plasma glucose, FPG: 5·6–6·9 mmol/L)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Recent body weight loss/gain >10%, within previous 3 months
*Recent bariatric surgery, within previous 6 months
*Significant current disease
*Pregnant or breastfeeding women
*Standard exclusions for DXA and MRI scanning techniques, including cardiac pacemaker

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/03/2020
Date of last participant enrolment
Anticipated
30/06/2021
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
400
Accrual to date
39
Final
Recruitment outside Australia
Country [1] 22443 0
New Zealand
State/province [1] 22443 0
Auckland

Funding & Sponsors
Funding source category [1] 305281 0
Government body
Name [1] 305281 0
National Science Challenge High Value Nutrition (HVN)
Country [1] 305281 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Level 10, Building 620
49 Symonds St
Auckland
1010
Country
New Zealand
Secondary sponsor category [1] 305643 0
None
Name [1] 305643 0
Address [1] 305643 0
Country [1] 305643 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305621 0
Southern Health and Disability Ethics Committees
Ethics committee address [1] 305621 0
Ethics committee country [1] 305621 0
New Zealand
Date submitted for ethics approval [1] 305621 0
27/10/2019
Approval date [1] 305621 0
26/02/2020
Ethics approval number [1] 305621 0
16/STH/23/AM09

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

Contacts
Principal investigator
Name 100990 0
Prof Sally D Poppitt
Address 100990 0
University of Auckland Human Nutrition Unit
18 Carrick Place
Mt Eden
Auckland 1024
Country 100990 0
New Zealand
Phone 100990 0
+64 96305160
Fax 100990 0
Email 100990 0
[email protected]
Contact person for public queries
Name 100991 0
Louise Lu
Address 100991 0
University of Auckland Human Nutrition Unit
18 Carrick Place
Mt Eden
Auckland 1024
Country 100991 0
New Zealand
Phone 100991 0
+64 96305160
Fax 100991 0
Email 100991 0
[email protected]
Contact person for scientific queries
Name 100992 0
Ivana Sequeira
Address 100992 0
University of Auckland Human Nutrition Unit
18 Carrick Place
Mt Eden
Auckland 1024
Country 100992 0
New Zealand
Phone 100992 0
+64 96305160
Fax 100992 0
Email 100992 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is in accordance to National Health and Disability Ethics Committees application that all data generated will only be used for this study only. However, if this is necessary additional consent will be obtained from participants to allow the use of data for other studies.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7404Study protocol    379483-(Uploaded-19-03-2020-13-11-29)-Study-related document.docx
7405Informed consent form    379483-(Uploaded-19-03-2020-13-11-51)-Study-related document.docx
7406Ethical approval    379483-(Uploaded-19-03-2020-13-12-17)-Study-related document.pdf



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.