Type 2 Diabetes
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Sitagliptin 100mg Qd
Sponsors
Beijing Chao Yang Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients 18-65 years old newly diagnosed with type 2 diabetes * HbA1c ≥ 7%
Exclusion criteria
* The positive of diabetes antibodies * Anti-diabetic drugs therapy before participation * Pancreatitis * Coronary artery disease * Liver function impairment * Renal function impairment * History of intestinal surgery * Chronic hypoxic diseases (emphysema and cor pulmonale) * Infectious disease * Hematological disease * Systemic inflammatory disease * Cancer * Pregnant * Ingesting agents known to influence glucose or lipid metabolism; * Any antibiotics or probiotics in the past three months prior to the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c change | Changes in HbA1c from baseline at 1 month and 3 months during follow-up | Changes in HbA1c from baseline at 1 month and 3 months during follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fasting blood glucose change | Changes in fasting blood glucose from baseline at 1 month and 3 months during follow-up | 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 | 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 | Changes in Glycated Albumin from baseline at 1 month and 3 months during follow-up |
Countries
China
Contacts
Primary ContactJia Liu, MD
Backup ContactYan Duan, MD
Outcome results
None listed