Effect of Gene Polymorphisms on GLP-1 Receptor Agonists Response in Patients With T2DM
Department of Pharmacy, the Affiliated Hospital of Xuzhou Medical University
1 other identifier
interventional
338
1 country
1
Brief Summary
- 1.This is an prospective study to evaluate the effect of gene polymorphisms on therapeutic responses to glucagon like peptide-1 receptor agonist (GLP-1 RA) in patients with T2DM.
- 2.T2DM patients and healthy subjects were recruited to identify genotypes and detect the level of T2DM susceptibility genes expression levels in the plasma of healthy participants and T2DM patients.
- 3.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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes-mellitus
Started Jan 2019
Longer than P75 for not_applicable type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2019
CompletedFirst Submitted
Initial submission to the registry
August 27, 2021
CompletedFirst Posted
Study publicly available on registry
September 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 2, 2024
CompletedNovember 12, 2024
November 1, 2024
4.7 years
August 27, 2021
November 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
Change from baseline HbA1c at 1 month
In order to observe the change from baseline HbA1c at 1 month after GLP-1 RA treatment
1 month after GLP-1 RA treatment
Change from baseline FPG at 1 month
In order to observe the change from baseline FPG at 1 month after GLP-1 RA treatment
1 month after GLP-1 RA treatment
Change from baseline PPG at 1 month
In order to observe the change from baseline PPG at 1 month after GLP-1 RA treatment
1 month after GLP-1 RA treatment
Change from baseline serum lipids at 1 month
In order to observe the change from baseline serum lipids at 1 month after GLP-1 RA treatment
1 month after GLP-1 RA treatment
Change from baseline HbA1c at 3 month
In order to observe the change from baseline HbA1c at 3 month after GLP-1 RA treatment
3 month after GLP-1 RA treatment
Change from baseline FPG at 3 month
In order to observe the change from baseline FPG at 3 month after GLP-1 RA treatment
3 month after GLP-1 RA treatment
Change from baseline PPG at 3 month
In order to observe the change from baseline PPG at 3 month after GLP-1 RA treatment
3 month after GLP-1 RA treatment
Change from baseline serum lipids at 3 month
In order to observe the change from baseline serum lipids at 3 month after GLP-1 RA treatment
3 month after GLP-1 RA treatment
Change from baseline HbA1c at 6 month
In order to observe the change from baseline HbA1c at 6 month after GLP-1 RA treatment
6 month after GLP-1 RA treatment
Change from baseline FPG at 6 month
In order to observe the change from baseline FPG at 6 month after GLP-1 RA treatment
6 month after GLP-1 RA treatment
Change from baseline PPG at 6 month
In order to observe the change from baseline PPG at 6 month after GLP-1 RA treatment
6 month after GLP-1 RA treatment
Change from baseline serum lipids at 6 month
In order to observe the change from baseline serum lipids at 6 month after GLP-1 RA treatment
6 month after GLP-1 RA treatment
Secondary Outcomes (3)
incidence and severity of possible adverse reaction within 1 month after GLP-1 RA treatment
1 month after GLP-1 RA treatment
incidence and severity of possible adverse reaction within 3 month after GLP-1 RA treatment
3 month after GLP-1 RA treatment
incidence and severity of possible adverse reaction within 6 month after GLP-1 RA treatment
6 month after GLP-1 RA treatment
Study Arms (1)
GLP-1 RA therapy
EXPERIMENTALGLP-1 RA was injected subcutaneously at standard dose and frequency for consecutive 6 months.
Interventions
GLP-1 RA was injected subcutaneously at standard dose and frequency for consecutive 6 months in patients with T2DM
Eligibility Criteria
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, 3 months, and 6 months after GLP-1 RA 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Endocrinology
Xuzhou, Jiangsu, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Renhao Wang, Ph.D
The Affiliated Hospital of Xuzhou Medical University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2021
First Posted
September 8, 2021
Study Start
January 10, 2019
Primary Completion
October 1, 2023
Study Completion
January 2, 2024
Last Updated
November 12, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share