Characterising the Pre-diabetic Asian and Caucasian Phenotype: the ‘TOFI’ Profile – 3-year Follow-up

Not Applicable

Recruiting

• Conditions: Diabetes; Diet and Nutrition - Obesity; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12621000001897
• Lead Sponsor: niversity of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-07
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 400

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)

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

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[3 years post-enrolment];Analysis of pancreas and liver fat deposition using untargeted LC-MS methodology in a subgroup of 100 female participants.[3 years post-enrolment ];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.[3 years post-enrolment ]

Secondary Outcome Measures

Name	Time	Method
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.[3 years post-enrolment.<br>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.];Determine cardiorespiratory fitness as assessed by the YMCA cycle ergometer submaximal test in 100 women.[ 3 years post-enrolment.<br>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.]