Use of Growth Differentiation Factor 15 as a Biomarker for Early Diagnosis of Diabetes Mellitus and Monitoring of Progress of Diabetic Peripheral Neuropathy in Asians

Previous studies have confirmed that mitochondria are associated with insulin resistance or diabetes. As the prevalence of type 2 diabetes mellitus (T2DM) continues to increase worldwide, early detection and intervention of diabetes can extend life expectancy, reduce complications and decrease medical expenses.

Significant differences in the expression of individual Growth Differentiation Factor 15 (GDF-15) proteins among Taiwanese harboring different mitochondrial genotypes are noted, and their blood serum levels also exhibited associations with diabetes. However, the relationship between GDF-15 and pre-diabetes and diabetes in Asian populations has yet to be fully investigated. In addition, any indirect associations between GDF-15 levels and diabetic complications remain unclear.

The investigators propose a two-year study project to elucidate several hot topics, including the level of GDF-15 in the initial diagnosis of diabetes in Asians if the interpretation is affected by drugs, and whether it is related to the progression of diabetes and related complications, such as diabetic nephropathy or peripheral neuropathy. By investigating mitochondrial genomic variations and the expression of related proteins, The investigators can determine the significant level of GDF-15 in the initial diagnosis of diabetes, medication effects, and diabetic complications. The DNA isolated from the blood samples will be evaluated by Luminex or Sanger sequencing method to determine individual mitochondria haplogroups, including variants located within the coding and control regions of the mitochondrial genome. The investigators aim to establish the significance of GDF-15 testing in Asian hyperglycemic populations. Our research is expected to have a positive impact on improving the early detection and interventional effectiveness of diabetes treatments, thereby reducing the financial burden on the global healthcare system.

The investigators plan to recruit patients, including 250 participants with pre-DM or DM and 250 participants as the control group. The investigators will enroll patients >20 years old and pregnant women will be excluded. Moving from the above considerations, the investigators will collect clinical information and lifestyle habits (smoking, alcohol consumption, physical activity, etc.) prospectively and review the medical records of these patients, who has newly-diagnosed impaired fasting glucose (IFG) or DM at the Chang Gung Memorial Hospital- Kaohsiung Medical Center since May, 2019. It takes about 1 year to collect the patient's specimen and data gradually, and the experiment takes about 1 year. For volunteers participating in the study, there is only a risk in the blood draw process.

For privacy protection and confidentiality, the investigators set a research code representing each participant's identity. This code will not display the name, identification number, and address. For the results and medical records, the Principal Investigator will carefully maintain privacy. If any research result is published, the participant's identity will remain confidential.