ANZCTR - Registration

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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]

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

Condition category

Condition code

Diet and Nutrition

Obesity

Metabolic and Endocrine

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]

Not applicable

Comparator / control treatment

Not applicable

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Baseline

Primary outcome [2]

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]

baseline

Secondary outcome [1]

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]

-10, 0, 2, 4, 6, 10,25, 30, 32, 34, 36, 40, 55 and 60 minutes

Secondary outcome [2]

Determine cardiorespiratory fitness as assessed by the YMCA cycle ergometer submaximal test

Timepoint [2]

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?

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]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Science Challenge High Value Nutrition (HVN)

Address [1]

Building 505
85 Park Road, Grafton
Auckland, 1023

Country [1]

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]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Comittees

Ethics committee address [1]

Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

10/03/2016

Approval date [1]

07/04/2016

Ethics approval number [1]

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

Prof Sally Poppitt

Address

University of Auckland Human Nutrition Unit
18 Carrick Place
Mt Eden
Auckland 1024

Country

New Zealand

Phone

+6496305160

Fax

s.poppitt@auckland.ac.nz

Contact person for public queries

Name

Wilson Yip

Address

University of Auckland Human Nutrition Unit
18 Carrick Place
Mt Eden
Auckland 1024

Country

New Zealand

Phone

+6496303744

Fax

w.yip@auckland.ac.nz

Contact person for scientific queries

Name

Sally Poppitt

Address

University of Auckland Human Nutrition Unit
18 Carrick Place
Mt Eden
Auckland 1024

Country

New Zealand

Phone

+6496305160

Fax

s.poppitt@auckland.ac.nz

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?

Doc. No.	Type	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

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	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
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

N.B. These documents automatically identified may not have been verified by the study sponsor.

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