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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
Type of registration
Prospectively registered

Titles & IDs
Public title
Characterising the Pre-diabetic Asian and Caucasian Phenotype: The 'TOFI' Profile
Scientific title
Characterising the Pre-diabetic Asian and Caucasian Phenotype: The 'TOFI' Profile: identifying biomarkers of diabetic susceptibility and resilience using a metabolomics platform.
Secondary ID [1] 287100 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 295622 0
Condition category
Condition code
Diet and Nutrition 295901 295901 0 0
Metabolic and Endocrine 298234 298234 0 0

Study type
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
200 Asian Chinese and 200 European Caucasian adults aged 18-70 years, normal weight or overweight having body-mass index (BMI) between 20-45 kg/m2, and either healthy or prediabetic will be enrolled into the study. They will be required to attend The Human Nutrition Unit (HNU), University of Auckland; anthropometry and fasted blood samples will be collected to determine risk of developing type 2 diabetes. Participants will also have a body composition dual energy x-ray absorptiometry (DeXA) scan to determine total and regional body fat at the Body Composition Laboratory, University of Auckland. In addition, 100 female participants only, due to gender differences in body composition, will be further asked if they would also like to have a Magnetic Resonance Imaging and Spectroscopy (MRI/S) scan, to determine ectopic and/or non-adipose tissue organ fat in pancreas and liver. These women will as undergo a short sub-maximal cardiorespiratory fitness (CRF) test, to assess their physical fitness which can also affect diabetes risk. Approximately 40 participants, that have undergone the MRI/S scan and CRF test, will also be asked if they would also like to undergo a routine clinical test to measure how well their pancreas secretes the important glucose regulating hormone insulin in response to a glucose challenge, using the intravenous glucose tolerance test (ivGTT). Furthermore, participants will also be asked to collect a stool/faecal sample, using a kit provided by the HNU, so that the gut microbiome can be determined.
Intervention code [1] 294185 0
Not applicable
Comparator / control treatment
Not applicable
Control group

Primary outcome [1] 297656 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)
Timepoint [1] 297656 0
Primary outcome [2] 297705 0
Identify novel metabolomic markers, that are predictive of pancreas and liver fat deposition and risk of developing type 2 diabetes using untargeted LC-MS methodology
Timepoint [2] 297705 0
Secondary outcome [1] 321729 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
Timepoint [1] 321729 0
-10, 0, 2, 4, 6, 10,25, 30, 32, 34, 36, 40, 55 and 60 minutes
Secondary outcome [2] 321925 0
Determine cardiorespiratory fitness as assessed by the YMCA cycle ergometer submaximal test
Timepoint [2] 321925 0
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.

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
Both males and females
Can healthy volunteers participate?
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
Defined population
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 7703 0
New Zealand
State/province [1] 7703 0

Funding & Sponsors
Funding source category [1] 293105 0
Government body
Name [1] 293105 0
National Science Challenge High Value Nutrition (HVN)
Address [1] 293105 0
Building 505
85 Park Road, Grafton
Auckland, 1023
Country [1] 293105 0
New Zealand
Primary sponsor type
University of Auckland
Level 10, Building 620
49 Symonds St
New Zealand
Secondary sponsor category [1] 291893 0
Name [1] 291893 0
Address [1] 291893 0
Country [1] 291893 0

Ethics approval
Ethics application status
Ethics committee name [1] 294606 0
Health and Disability Ethics Comittees
Ethics committee address [1] 294606 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Ethics committee country [1] 294606 0
New Zealand
Date submitted for ethics approval [1] 294606 0
Approval date [1] 294606 0
Ethics approval number [1] 294606 0

Brief summary
Background: People of Asian descent are at much greater risk of poor metabolic health and diabetes at a younger age and a lower body weight than those of European Caucasian descent. The reason why some individuals are more susceptible than others and what controls their diabetes risk may lie in the storage of body fat, and may be identified through early changes in serum metabolite profile. Gaining even small amounts of body weight can lead to the fat ‘spilling over’ from adipose tissue and into important organs such as the muscle, liver and pancreas, which in turn may significantly increase risk of disease. Often known as the TOFI profile – ‘Thin on the Outside, Fat on the Inside’ – people who appear ostensibly slim and/or mildly overweight can develop diabetes whilst those who are very overweight and/or obese may not. Few predictive biomarkers of early diabetes risk and propensity to susceptibility or resilience have yet been determined.
Objective: To investigate diabetic risk profile, susceptibility and resilience to weight gain and increasing adiposity in a population of Asian Chinese and Caucasian adults; using body composition and metabolomic techniques.
Design: This is a cross-sectional study, 400 participants, aged 18-70 years, of Asian Chinese (n=200) or Caucasian European (n=200) ethnicity. A fasting blood sample will be collected to assess diabetic profile based on fasting plasma glucose, and also for untargeted metabolomics profiling; whole body and segmental fat free mass and adipose tissue fat mass will be measured on a single occasion using DEXA scanning; and in a subset of 100 individuals ectopic lipid storage in key organs including liver, pancreas and muscle will be measured using MRI/S.
Findings: This is a program conducted within the National Science Challenge High Value Nutrition (HVN) program which aims to determine novel prediabetic biomarkers which, in future studies may be shown to be responsive to nutrition intervention.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 58830 0
Prof Sally Poppitt
Address 58830 0
University of Auckland Human Nutrition Unit
18 Carrick Place
Mt Eden
Auckland 1024
Country 58830 0
New Zealand
Phone 58830 0
Fax 58830 0
Email 58830 0
Contact person for public queries
Name 58831 0
Mr Wilson Yip
Address 58831 0
University of Auckland Human Nutrition Unit
18 Carrick Place
Mt Eden
Auckland 1024
Country 58831 0
New Zealand
Phone 58831 0
Fax 58831 0
Email 58831 0
Contact person for scientific queries
Name 58832 0
Prof Sally Poppitt
Address 58832 0
University of Auckland Human Nutrition Unit
18 Carrick Place
Mt Eden
Auckland 1024
Country 58832 0
New Zealand
Phone 58832 0
Fax 58832 0
Email 58832 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 5821 0
Study protocol
Citation [1] 5821 0
Link [1] 5821 0
Email [1] 5821 0
Other [1] 5821 0
Type [2] 5822 0
Informed consent form
Citation [2] 5822 0
Link [2] 5822 0
Email [2] 5822 0
Other [2] 5822 0
Type [3] 5823 0
Ethical approval
Citation [3] 5823 0
Link [3] 5823 0
Email [3] 5823 0
Other [3] 5823 0
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary