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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-70
SponsorThe Affiliated Hospital of Xuzhou Medical University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: efficacy difference of GLP-1RAExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
6 month after GLP-1 RA treatment
2

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

Time frame
1 month after sample integration
3

Genotype identification in patients with T2DM

Blood samples were collected from T2DM patients for genotyping

Time frame
1 month after sample collecting

Secondary outcomes

1

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

Time frame
6 months after GLP-1 RA treatment

Other outcomes

Sponsors and contacts

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