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Trial registered on ANZCTR
Registration number
ACTRN12616000362493
Ethics application status
Approved
Date submitted
12/03/2016
Date registered
21/03/2016
Date last updated
22/11/2019
Date data sharing statement initially provided
22/11/2019
Date results information initially provided
22/11/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Characterising the Pre-diabetic Asian and Caucasian Phenotype: The 'TOFI' Profile
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Scientific title
Characterising the Pre-diabetic Asian and Caucasian Phenotype: The 'TOFI' Profile: identifying biomarkers of diabetic susceptibility and resilience using a metabolomics platform.
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Secondary ID [1]
287100
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Nil
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Universal Trial Number (UTN)
U1111-1243-5250
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Trial acronym
HVN PANaMAH TOFI
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes
295622
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Condition category
Condition code
Diet and Nutrition
295901
295901
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0
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Obesity
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Metabolic and Endocrine
298234
298234
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0
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Diabetes
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
294185
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Not applicable
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Comparator / control treatment
Not applicable
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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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)
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Assessment method [1]
297656
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Timepoint [1]
297656
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Baseline
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Primary outcome [2]
297705
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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
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Assessment method [2]
297705
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Timepoint [2]
297705
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baseline
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Secondary outcome [1]
321729
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Determine the impact of MRI determined pancreas and liver fat on pancreatic beta-cell function and insulin secretion using an intravenous glucose tolerance test
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Assessment method [1]
321729
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Timepoint [1]
321729
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-10, 0, 2, 4, 6, 10,25, 30, 32, 34, 36, 40, 55 and 60 minutes
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Secondary outcome [2]
321925
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Determine cardiorespiratory fitness as assessed by the YMCA cycle ergometer submaximal test
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Assessment method [2]
321925
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Timepoint [2]
321925
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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.
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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)
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
23/05/2016
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Actual
14/06/2016
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Date of last participant enrolment
Anticipated
1/04/2017
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Actual
20/01/2017
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Date of last data collection
Anticipated
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Actual
3/04/2017
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Sample size
Target
400
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Accrual to date
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Final
383
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Recruitment outside Australia
Country [1]
7703
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New Zealand
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State/province [1]
7703
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Auckland
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Funding & Sponsors
Funding source category [1]
293105
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Government body
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Name [1]
293105
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National Science Challenge High Value Nutrition (HVN)
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Address [1]
293105
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Building 505
85 Park Road, Grafton
Auckland, 1023
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Country [1]
293105
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New Zealand
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Primary sponsor type
University
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Name
University of Auckland
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Address
Level 10, Building 620
49 Symonds St
Auckland
1010
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Country
New Zealand
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Secondary sponsor category [1]
291893
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None
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Name [1]
291893
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None
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Address [1]
291893
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None
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Country [1]
291893
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
294606
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Health and Disability Ethics Comittees
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Ethics committee address [1]
294606
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Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011
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Ethics committee country [1]
294606
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New Zealand
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Date submitted for ethics approval [1]
294606
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10/03/2016
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Approval date [1]
294606
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07/04/2016
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Ethics approval number [1]
294606
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16/STH/23
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Summary
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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
58830
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Prof Sally Poppitt
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Address
58830
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University of Auckland Human Nutrition Unit
18 Carrick Place
Mt Eden
Auckland 1024
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Country
58830
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New Zealand
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Phone
58830
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+6496305160
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Fax
58830
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Email
58830
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[email protected]
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Contact person for public queries
Name
58831
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Mr Wilson Yip
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Address
58831
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University of Auckland Human Nutrition Unit
18 Carrick Place
Mt Eden
Auckland 1024
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Country
58831
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New Zealand
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Phone
58831
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+6496303744
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Fax
58831
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Email
58831
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[email protected]
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Contact person for scientific queries
Name
58832
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Prof Sally Poppitt
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Address
58832
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University of Auckland Human Nutrition Unit
18 Carrick Place
Mt Eden
Auckland 1024
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Country
58832
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New Zealand
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Phone
58832
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+6496305160
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Fax
58832
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Email
58832
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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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.
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What supporting documents are/will be available?
No Supporting Document Provided
Current supporting documents:
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
5821
Study protocol
368943-(Uploaded-13-11-2019-14-07-50)-Study-related document.pdf
5822
Informed consent form
368943-(Uploaded-13-11-2019-14-11-49)-Study-related document.pdf
5823
Ethical approval
368943-(Uploaded-13-11-2019-14-21-50)-Study-related document.pdf
Updated to:
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
5821
Study protocol
368943-(Uploaded-24-03-2020-10-54-34)-Study-related document.docx
5822
Informed consent form
368943-(Uploaded-24-03-2020-10-52-29)-Study-related document.docx
5823
Ethical approval
368943-(Uploaded-24-03-2020-10-53-39)-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
Source
Title
Year of Publication
DOI
Embase
Pancreas Fat, an Early Marker of Metabolic Risk? A Magnetic Resonance Study of Chinese and Caucasian Women: TOFI_Asia Study.
2022
https://dx.doi.org/10.3389/fphys.2022.819606
Embase
Exploring the relationship between pancreatic fat and insulin secretion in overweight or obese women without type 2 diabetes mellitus: A preliminary investigation of the TOFI_Asia cohort.
2022
https://dx.doi.org/10.1371/journal.pone.0279085
N.B. These documents automatically identified may not have been verified by the study sponsor.
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