Trial Review

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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
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
Nil
Universal Trial Number (UTN)
U1111-1243-5250
Trial acronym
HVN PANaMAH TOFI
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
Obesity
Metabolic and Endocrine 298234 298234 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
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
Uncontrolled

Outcomes
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
Baseline
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
baseline
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.

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
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/05/2016
Actual
14/06/2016
Date of last participant enrolment
Anticipated
1/04/2017
Actual
20/01/2017
Date of last data collection
Anticipated
Actual
3/04/2017
Sample size
Target
400
Accrual to date
Final
383
Recruitment outside Australia
Country [1] 7703 0
New Zealand
State/province [1] 7703 0
Auckland

Funding & Sponsors
Funding source category [1] 293105 0
Government body
Name [1] 293105 0
National Science Challenge High Value Nutrition (HVN)
Country [1] 293105 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] 291893 0
None
Name [1] 291893 0
None
Address [1] 291893 0
None
Country [1] 291893 0

Ethics approval
Ethics application status
Approved
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
Wellington
6011
Ethics committee country [1] 294606 0
New Zealand
Date submitted for ethics approval [1] 294606 0
10/03/2016
Approval date [1] 294606 0
07/04/2016
Ethics approval number [1] 294606 0
16/STH/23

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
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
+6496305160
Fax 58830 0
Email 58830 0
[email protected]
Contact person for public queries
Name 58831 0
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
+6496303744
Fax 58831 0
Email 58831 0
[email protected]
Contact person for scientific queries
Name 58832 0
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
+6496305160
Fax 58832 0
Email 58832 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?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5821Study protocol    368943-(Uploaded-13-11-2019-14-07-50)-Study-related document.pdf
5822Informed consent form    368943-(Uploaded-13-11-2019-14-11-49)-Study-related document.pdf
5823Ethical approval    368943-(Uploaded-13-11-2019-14-21-50)-Study-related document.pdf


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5821Study protocol    368943-(Uploaded-24-03-2020-10-54-34)-Study-related document.docx
5822Informed consent form    368943-(Uploaded-24-03-2020-10-52-29)-Study-related document.docx
5823Ethical 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
SourceTitleYear of PublicationDOI
EmbaseExploring 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.2022https://dx.doi.org/10.1371/journal.pone.0279085
EmbasePancreas Fat, an Early Marker of Metabolic Risk? A Magnetic Resonance Study of Chinese and Caucasian Women: TOFI_Asia Study.2022https://dx.doi.org/10.3389/fphys.2022.819606
N.B. These documents automatically identified may not have been verified by the study sponsor.