A Phase 4 interventional study of Sitagliptin 100mg in Type 2 Diabetes, sponsored by Beijing Chao Yang Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-07-28.
Sponsored by Beijing Chao Yang Hospital · Phase 4, Interventional, and Basic science
Patients newly diagnosed with T2D will be recruited and will receive sitagliptin treatment for 3 months. The gut microbiome of the participants before and after the treatment and the effectiveness of sitagliptin treatment on type 2 diabetes will be evaluated.
The dipeptidyl peptidase-4 inhibitor sitagliptin is a classic anti-diabetic drug(1) and is widely applied to both scientific research and clinical trial(2-6). This clinical trial aims to study the effectiveness of sitagliptin treatment in T2D patients and related change of gut microbiome. 50 Patients newly diagnosed with T2D will be recruited. With patient's informed consent, patient-related vital signs (such as age, height, weight, body mass index), laboratory indicators (including glycated hemoglobin, glycated albumin, low-density lipoprotein, total cholesterol, triglycerides), fasting blood glucose, insulin levels and Insulin resistance index (HOMA-IR)(7) will be recorded and analyzed. The feces of the patients will be collected to analyze the gut microbiome. All of the patients will receive the sitagliptin treatment for 3 months. The gut microbiome of the patients and the effectiveness of sitagliptin treatment on diabetes will be evaluated at indicated times during follow-up.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 50 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Beijing Chao Yang Hospital is the lead sponsor of 135 studies on the registry; 49 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
sitagliptin 100mg
Drug: Sitagliptin 100mg
Sitagliptin 100mg Qd
HbA1c change
Changes in HbA1c from baseline at 1 month and 3 months during follow-up
Time frame: Changes in HbA1c from baseline at 1 month and 3 months during follow-up
fasting blood glucose change
Changes in fasting blood glucose from baseline at 1 month and 3 months during follow-up
Time frame: Changes in fasting blood glucose from baseline at 1 month and 3 months during follow-up
HOMA-IR change
Changes in HOMA-IR from baseline at 1 month and 3 months during follow-up
Time frame: Changes in HOMA-IR from baseline at 1 month and 3 months during follow-up
Glycated Albumin（GSA）change
Changes in Glycated Albumin from baseline at 1 month and 3 months during follow-up
Time frame: Changes in Glycated Albumin from baseline at 1 month and 3 months during follow-up
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Beijing Chao Yang Hospital