Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06256419
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2024-02-05
Brief Title:
Association of Gene Polymorphism With Susceptibility to T2DM and the Therapeutic Responses to Exenatide in Chinese Patients With T2DM
Sponsor:
The Affiliated Hospital of Xuzhou Medical University
Organization:
The Affiliated Hospital of Xuzhou Medical University
Study Overview
Official Title:
Department of Pharmacy the Affiliated Hospital of Xuzhou Medical University
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
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:
This is a retrospective cohort study of patients with T2DM who were treated with exenatide twice daily as a part of their diabetes care for at least 12 months The objective of this study is to investigate the influence of T2DM susceptibility gene polymorphisms NOS1AP KCNQ1 TCF7L2 WSF1 GLP-1R etc on the efficacy of GLP-1 RA exenatide liraglutide etc to identify the variables that can predict the efficacy of GLP-1 RA and to evaluate the weight of these variables on the efficacy
Detailed Description:
T2DM is a polygenic genetic disease The individual differences in the efficacy of antidiabetic drugs are caused by the cumulative effect of multiple gene polymorphisms and are related to environmental factors and lifestyle The results of single gene polymorphism cannot fully explain the individual differences in the efficacy of antidiabetic drugs Verifying the correlation between T2DM gene polymorphisms and the efficacy of antidiabetic drugs clarifying the genetic determinants of individual differences in the efficacy of antidiabetic drugs and predicting the efficacy and side effects of antidiabetic drugs are of great significance for the formulation of precise medication regimens for T2DM patients
Many guidelines recommend the preferential use of GLP-1 RA after single drug or multiple oral hypoglycemic drugs and basic insulin therapy for poor glycemic control However the clinical responsiveness to GLP-1 RA varies among patients with T2DM It has been reported that genetic factors are the important reasons for individual variation in therapeutic response of antidiabetic drugs At present dozens of gene loci related to therapeutic response of antidiabetic drugs have been screened which are of great clinical significance in guiding clinical individualized treatment improving the efficacy and safety of drugs and reducing the drug costs
GLP-1 RA was injected subcutaneously at standard dose and frequency for consecutive 6 months The patients were visited at moths 0 3 and 6 and medical histories physical examinations and routine clinical laboratory tests were performed during these visits The general anthropometric parameters considered for this study were height m weight kg and waist and hip circumferences cm at baseline 3 months and 6months after exenatide treatment
Patients who had an HbA1c reduction 10 or HbA1c lt70 after exenatide treatment for six consecutive months were considered responders while patients who failed to achieve this decrease were considered non-responders The clinical data were collected and analyzed to determine the variables that could predict the efficacy of GLP-1 RA and to evaluate the weight of the influence of these variables on the efficacy
Many guidelines recommend the preferential use of GLP-1 RA after single drug or multiple oral hypoglycemic drugs and basic insulin therapy for poor glycemic control However the clinical responsiveness to GLP-1 RA varies among patients with T2DM It has been reported that genetic factors are the important reasons for individual variation in therapeutic response of antidiabetic drugs At present dozens of gene loci related to therapeutic response of antidiabetic drugs have been screened which are of great clinical significance in guiding clinical individualized treatment improving the efficacy and safety of drugs and reducing the drug costs
GLP-1 RA was injected subcutaneously at standard dose and frequency for consecutive 6 months The patients were visited at moths 0 3 and 6 and medical histories physical examinations and routine clinical laboratory tests were performed during these visits The general anthropometric parameters considered for this study were height m weight kg and waist and hip circumferences cm at baseline 3 months and 6months after exenatide treatment
Patients who had an HbA1c reduction 10 or HbA1c lt70 after exenatide treatment for six consecutive months were considered responders while patients who failed to achieve this decrease were considered non-responders The clinical data were collected and analyzed to determine the variables that could predict the efficacy of GLP-1 RA and to evaluate the weight of the influence of these variables on the efficacy
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?:
False
Is an FDA AA801 Violation?:
None