RecruitingNot ApplicableNCT06256419

Association of Gene Polymorphism With Susceptibility to T2DM and the Therapeutic Responses to Exenatide in Chinese Patients With T2DM

Department of Pharmacy, the Affiliated Hospital of Xuzhou Medical University


Sponsor

The Affiliated Hospital of Xuzhou Medical University

Enrollment

300 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 25 YearsMax Age: 70 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria3

  • 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.

Interventions

DRUGGLP-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.

DRUGresponders 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 were divided into responses group and nonresponses group according to whether they had glycemic response (△HbA1c↓ ≥1.0%) and weight response (△weight↓ ≥3.0%) after taking GLP-1 receptor agonist for 6 months. According to the above grouping, the variables that can predict the efficacy of the drug were identified, and the weight of the influence of these variables on the efficacy was evaluated.


Locations(1)

China, Jiangsu, Department of Endocrinology

Xuzhou, China, China

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NCT06256419


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