Ignite Creation Date:
2024-05-06 @ 1:44 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04119167
Status:
UNKNOWN
Last Update Posted:
2019-10-08
First Post:
2019-09-22
Brief Title:
Use of GDF15 as a Biomarker for Early Diagnosis of DM and Monitoring of Progress of Complications in Asians
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
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
Status:
UNKNOWN
Status Verified Date:
2019-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 GDF-15 was originally discovered as an autocrine regulator of macrophage activation and shown to play important roles in fibrosis malignancy cardiovascular disease glycemic control and obesity However the relationship between GDF-15 and pre-diabetes and diabetes in Asian populations has yet to be fully investigated Besides any indirect associations between GDF-15 levels and diabetic complications remain unclear The investigators aim to further investigate the role of GDF-15 levels in the initial diagnosis of diabetes the monitoring of medication effectiveness and disease progression and related complications such as diabetic nephropathy and neuropathy The DNA isolated from the blood samples will be evaluated to determine individual mitochondria haplogroups including variants located within the coding and control regions of the mitochondrial genome
Detailed Description:
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 patients 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 participants 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 participants identity will remain confidential
GDF15 is a non-glucose protein and only one fasting blood sample is needed Serum GDF15 level is stable at room temperature for 48 hours with consistent value despite four freezethaw cycles 20 hours at -70C followed by 4 hours at room temperature The anticoagulant used for sampling does not affect the measurements One factor affecting the interpretation of GDF15 is pregnancy In a study about the association between GDF15 and pregnancy and hyperemesis gravidarum the association between the genes GDF15 and IGFBP7 and hyperemesis was found GDF15 is highly expressed in placental trophoblast cells and its protein appears to promote placentation via activation of neurons in the hypothalamus and area postrema vomiting center of the brainstem IGFBP7 also plays a role in placentation appetite and cachexia Therefore circulating the GDF15 level is affected by the state of pregnancy Thats why the investigators will exclude pregnant women in our study
After the research team explains the protocol and review of the informed consent form The Institutional Review Board No 201900948B0C601 informed consent form Version 3 The patient has all the questions answered and signed consent prior to any study procedure A copy of the signed consent will be given to the patient The samples of blood count and the extracted DNA will be measured within one year including the haplogroup the mitochondrial gene single set and mitochondrial control region and binding gene variant The storage location is the tissue bank of Kaohsiung Medical Center of Chang Gung Memorial Hospital
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 patients 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 participants 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 participants identity will remain confidential
GDF15 is a non-glucose protein and only one fasting blood sample is needed Serum GDF15 level is stable at room temperature for 48 hours with consistent value despite four freezethaw cycles 20 hours at -70C followed by 4 hours at room temperature The anticoagulant used for sampling does not affect the measurements One factor affecting the interpretation of GDF15 is pregnancy In a study about the association between GDF15 and pregnancy and hyperemesis gravidarum the association between the genes GDF15 and IGFBP7 and hyperemesis was found GDF15 is highly expressed in placental trophoblast cells and its protein appears to promote placentation via activation of neurons in the hypothalamus and area postrema vomiting center of the brainstem IGFBP7 also plays a role in placentation appetite and cachexia Therefore circulating the GDF15 level is affected by the state of pregnancy Thats why the investigators will exclude pregnant women in our study
After the research team explains the protocol and review of the informed consent form The Institutional Review Board No 201900948B0C601 informed consent form Version 3 The patient has all the questions answered and signed consent prior to any study procedure A copy of the signed consent will be given to the patient The samples of blood count and the extracted DNA will be measured within one year including the haplogroup the mitochondrial gene single set and mitochondrial control region and binding gene variant The storage location is the tissue bank of Kaohsiung Medical Center of Chang Gung Memorial Hospital
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None