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

NCT06256419 | Recruiting

• 1 other identifier: XYFY2023-KL479-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus; Susceptibility, Genetic

Keywords

Type 2 Diabetes Mellitus; GLP-1 RA; gene polymorphism; susceptibility gene; variation

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• Incidence and severity of possible adverse reaction within 6 month after GLP-1 RA treatment

  6 months after GLP-1 RA treatment

Study Arms (1)

efficacy difference of GLP-1RA

EXPERIMENTAL

Responders group and non-responders group

Drug: GLP-1 receptor agonist; Drug: responders group and nonresponders group

Interventions

GLP-1 receptor agonist DRUG

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.

efficacy difference of GLP-1RA

responders group and nonresponders group DRUG

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.

efficacy difference of GLP-1RA

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead

Study Sites (1)

China, Jiangsu, Department of Endocrinology

Xuzhou, China, 221006, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tao Wang, Ph.D

CONTACT

13815344640; misswt2011@126.com

Xiaoxing Yin, Ph.D

CONTACT

13605218523; yinxx@xzmc.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)