None listed
Conditions
Brief summary
Obesity and its associated diseases have rapidly risen to become a significant burden on health systems across the world. Australia is not immune to this upheaval, with nearly 2 in 3 adults in this country classified as overweight or obese. In line with rising obesity, rates of diabetes have also risen dramatically. In the 2017-2018 Australian Bureau of Statistics Health Survey, 4.9% of respondents reported a diagnosis of diabetes. Furthermore, it is estimated that diabetes was an associated or underlying cause for 11% of deaths in the year 2018. Even without progression to diabetes, obese individuals are at risk of a host of other health issues such as the development of Nonalcoholic fatty liver disease (NAFLD). There is an urgent need for new ways to manage the metabolic diseases of obesity. However, there is a lack of diagnostic tests that can accurately predict diabetes before to the appearance of the symptoms that indicate that the first steps into full disease have already occurred. New evidence shows that inflammation of the deep fat stores that surround our organs plays a key role in health and obesity. It is now known that fat tissue is not just a passive storage site for excess energy but rather a complex organ that can disrupt the healthy hormonal and metabolic profile of obese patients. This inflammatory process occurs very early on in the development of disease, before the onset of diabetes and pre-diabetes symptoms. Ongoing inflammation of organ fat results in high rates of cell death in this tissue and the release of unwanted cell free DNA into the surrounding tissues and blood circulation. This free DNA can actually increase the level of inflammation via a negative feedback loop that serves to strengthen this unwanted response. At CSIRO, we have developed a new blood test that can measure the amount of DNA being released by these fat cells. This new test may provide a window into health for obese patients that can help doctors predict and monitor long-term health well before a diabetes diagnosis could be determined using current measures. This study will test the validity or our new blood test, in a group of patients who will be profiled for a well defined set of biomarkers that measure metabolic and liver health. This study is funded by CSIRO.
Interventions
This trial comprises a dual site, non-intervention cross-sectional observational study. The study population will comprise of up to 100 obese individuals of unknown metabolic health. The primary objective is to validate a cell free DNA based blood assay for its ability to identify individuals of poor metabolic health. Participants will undergo a single face-to-face assessment at CSIRO's Adelaide (SAHMRI) and Westmead trial facilities of approximately 1 hour duration with no further visits requi
This trial comprises a dual site, non-intervention cross-sectional observational study. The study population will comprise of up to 100 obese individuals of unknown metabolic health. The primary objective is to validate a cell free DNA based blood assay for its ability to identify individuals of poor metabolic health. Participants will undergo a single face-to-face assessment at CSIRO's Adelaide (SAHMRI) and Westmead trial facilities of approximately 1 hour duration with no further visits required. Before attending, subjects will complete a screening questionnaire to ensure suitability, which will be verified by the clinic team on arrival. Screening and anthropomorphic measurements will be performed by the clinical trial coordinator, all blood collections will be made by a trained Registered Nurse and/or phlebotomist. Participants will be classified as metabolically healthy or metabolically abnormal obese. Groups will be further assessed for indicators of liver health (fibrosis and fatty liver). Health status will be assessed using the below set of biomarkers: o Blood Pressure (mmHg) o Blood Glucose concentration o Blood HbA1c concentration o Blood Platelet Count o Serum Triglycerides o Serum HDL-Cholesterol o Serum LDL-Cholesterol o Serum total Cholesterol o Serum Insulin concentration o Serum hsCRP concentration o Serum AST concentration o Serum ALT concentration o Serum GGT concentration o Serum albumin concentration o Waist circumference (cm) o Hip circumference (cm) o BMI (kg/m2), Weight (kg), Height (cm) A further blood sample will be provided for the purpose of epigenetic analysis of the cell free DNA. Cell free DNA concentrations will be compared to metabolic and liver health biomarkers above to assess the clinical validity of a novel blood test for metabolic health.
Sponsors
Commonwealth Scientific and Industrial Research Organisation
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Willing to provide written Informed Consent 2. Aged from >=18 to <56 years of age at clinic visit 3. BMI >=30 and <=35 kg/m2 confirmed at visit 4. Willing to fast at least 10 hours before attending clinic visit
Exclusion criteria
1. Currently pregnant and/or nursing (lactating) 2. Diagnosis of insulin resistance, diabetes (Type I, Type II and/or Gestational Diabetes), cancer including skin cancer, and immunological disease 3. Current or prior chemotherapy/radiotherapy treatment 4. Current use or use 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. Average Systolic BP >=180mmHg or Diastolic BP >= 110mmHg 7. In the opinion of the Principal Investigator, unable to comply and/or experience distress with study procedures.
Outcome results
None listed