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Clinical Trial NCT06256419 for Type 2 Diabetes Mellitus, Susceptibility, Genetic is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Association of Gene Polymorphism With Susceptibility to T2DM and the Therapeutic Responses to Exenatide in Chinese Patients With T2DM 300
Clinical Trial NCT06256419 is an interventional study for Type 2 Diabetes Mellitus, Susceptibility, Genetic that is recruiting. It started on 1 January 2024 with plans to enroll 300 participants. Led by The Affiliated Hospital of Xuzhou Medical University, it is expected to complete by 31 January 2028. The latest data from ClinicalTrials.gov was last updated on 18 September 2025.
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 efficac...Show More
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 e...Show More
Official Title
Department of Pharmacy, the Affiliated Hospital of Xuzhou Medical University
Conditions
Type 2 Diabetes MellitusSusceptibility, GeneticOther Study IDs
- XYFY2023-KL479-01
NCT ID Number
Start Date (Actual)
2024-01-01
Last Update Posted
2025-09-18
Completion Date (Estimated)
2028-01-31
Enrollment (Estimated)
300
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Type 2 Diabetes Mellitus
GLP-1 RA
gene polymorphism
susceptibility gene
variation
GLP-1 RA
gene polymorphism
susceptibility gene
variation
Primary Purpose
Prevention
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Experimentalefficacy difference of GLP-1RA Responders group and non-responders group | GLP-1 receptor agonist Eligible patients with T2DM were required to have received GLP-1RA as monotherapy or in combination with other antidiabetic agents. GLP-1 RA was injected subcutaneously at standard dose and frequency for consecutive 6 months in patients with T2DM. responders group and nonresponders group For all the patients with type 2 diabetes who were initially enrolled in the study, blood samples were obtained for genotyping before the administration of GLP-1 receptor agonists. Patients were re-screened according to whether they had used GLP-1 RA continuously for more than 6 months and had completed the specified follow-up tasks.
Patients were divided according to the type of T2DM susceptibility genes. Or all we...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change from baseline HbA1c and baseline weight at 6 month | In order to observe the change from baseline HbA1c and baseline weight at 6 month after GLP-1 RA treatment | 6 month after GLP-1 RA treatment |
To identify and evaluate the variable factors influencing GLP-1 RA efficacy | The variable factors that predict the efficacy of GLP-1 RA were identified and the weight these variables on the efficacy was assessed | 1 month after sample integration |
Genotype identification in patients with T2DM | Blood samples were collected from T2DM patients for genotyping | 1 month after sample collecting |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Incidence and severity of possible adverse reaction within 6 month after GLP-1 RA treatment | To evaluate the incidence and severity of possible adverse reaction within 6 month after GLP-1 RA treatment, including gastrointestinal reaction and hypoglycemia | 6 months after GLP-1 RA treatment |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
25 Years
Eligible Sexes
All
- a diagnosis of T2DM
- a body mass index (BMI) of 20-35 kg/m2
- an HbA1c of 7.0%-12%, an age of 25-70 years
- required data available at baseline and 6 months after GLP-1RA therapy.
- Patients with serious diseases such as acute myocardial infarction, cerebral vascular accident, trauma, kidney or liver diseases, severe gastrointestinal dysfunction, and history of pancreatitis
- patients receiving GLP-1 analogues, weight loss drugs, glucocorticoids, drugs affecting gastrointestinal peristalsis in the past 3 months
- those with missing data at the time points of baseline, 3 months, and 6 months after GLP-1 RA therapy.
The Affiliated Hospital of Xuzhou Medical UniversityStudy Central Contact
Contact: Tao Wang, Ph.D, 13815344640, [email protected]
Contact: Xiaoxing Yin, Ph.D, 13605218523, [email protected]
1 Study Locations in 1 Countries
China
China, Jiangsu, Department of Endocrinology, Xuzhou, China, 221006, China
Hongwei Ling, MD, Contact, 18052268607, [email protected]
Renguo Chen, MD, Principal Investigator
Yuhan Huang, MD, Sub-Investigator
Recruiting