A new blood test for the early detection of metabolic diseases

About this study

Rates of obesity and metabolic diseases such as diabetes and non-alcoholic fatty liver disease are growing rapidly around the world. Our health systems need new tools to better understand how to help patients in their health journey. CSIRO has created a new blood test that may be able to detect the first steps toward ill-health before traditional symptoms appear. In this clinical trial, we aim to validate our early findings so we can prepare our blood test for further clinical development.

The metabolic syndrome

• Hypertension
• Cancer
• PCOS
• Heart Disease
• Dementia
• NAFLD
• Insulin Resistance
• Lipid Problems
• Type 2 Diabetes

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How long will participation in the trial take?

This trial requires one clinic visit which will go for approximately 1 hour.

Who can participate in this study?

1. You are willing to provide written informed consent
2. You are aged 18 years or older but less than 56 years of age at clinic visit
3. You have a BMI greater than or equal to 30 and less than 35 kg/m2 (we will check this at your visit). Check your BMI
4. You are willing to fast (only water) for at least 10 hours before attending clinic visit

Who is unable to participate in this study?

If you meet the following criteria – this study is not the best fit for you:

1. You are currently pregnant and/or nursing (lactating)
2. You have a diagnosis of insulin resistance, diabetes (Type I, Type II and/or Gestational Diabetes), cancer including skin cancer and / or immunological disease
3. You have current or had prior chemotherapy/radiotherapy treatment
4. You currently use or have used of the following medications in the last 84 days prior to clinic visit:
   • Metformin
   • Fortamet
   • Glucophage
   • Glucophage XR
   • Glumetza
   • Riomet
   • N,N-dimethylbiguanide
5. Experienced physical injury 14 days prior to clinic visit that meets any of the following:
   • Required medical assessment and/or treatment
   • Resulted in pain, bruising and/or sensitivity lasting longer than 14 days or is currently being experienced.
   • Resulted in limited movement and mobility
6. Systolic blood pressure (BP) greater than or equal too (≥) 180mmHg or Diastolic BP (≥) 110mmHg average or one reading.
7. In the opinion of the Principal Investigator or delegate, unable to comply and/or experience distress with study procedures or has a medical condition which in the opinion of the Principal Investigator may affect the diagnostic test.

Where can I attend a visit?

• CSIRO Nutrition and Health Clinic at SAHMRI, Adelaide

Will I be reimbursed for my time?

You will receive a $60.00 gift card for your time. We will also provide you with a light breakfast.

What if I have more questions about the study?

For more information, please read the detailed Participant Information Sheet PDF (179 KB)

If you feel you fit the criteria and would like to take part, please complete the online study registration form selecting “Clinical validation of circulating cell free DNA [ccfDNA] as a biomarker of metabolic health” from the drop-down menu.

This study has been approved by the CSIRO Human Research Ethics Committee. HREC number 2022_006_HREC [21JUL2022]