Sitagliptin for the Treatment of Type 2 Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of Sitagliptin for the Treatment of Newly Diagnosed Type 2 Diabetes

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Sitagliptin 100mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sitagliptin<br>sitagliptin 100mg | Drug: Sitagliptin 100mg<br>* Sitagliptin 100mg Qd<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |