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 volunteersQualifiers
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
Single group
Treatments tested in this trial
GLP-1 receptor agonist
DrugEligible 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
DrugFor 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
Trial outcomes
Primary outcomes
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
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
Genotype identification in patients with T2DM
Blood samples were collected from T2DM patients for genotyping
Secondary outcomes
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
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