Evaluate the Effect of Saxagliptin on Gut Microbiota in Patients With Newly Diagnosed Type 2 Diabetes

Beijing Chao Yang Hospital100 enrolled

Overview

The intestinal microflora imbalance has been associated with obesity and type 2 diabetes. The researchers' study aimed to investigate the effect of saxagliptin on gut microbiota in patients with newly diagnosed type 2 diabetes.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Type 2 Diabetes Obesity

Interventions

Saxagliptin (Bristol-Myers Squibb Company)DRUG

6-month treatment of Saxagliptin 5mg Qd

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Females or males, and aged 20 to 65 years. * Newly diagnosed type 2 diabetes * HbA1C ≥7% and HbA1C \<9% Exclusion Criteria: * Hepatic insufficiency (ALT or AST\> 1.5\*ULN) * Renal insufficiency \[Creatinine clearance rate (Ccr)\]\<60ml/min estimated from MDRD equation) * Coronary artery disease * Thyroid disease * Infectious disease * Systemic inflammatory disease * Cancer * Subjects who were taking agents known to influence gut microbiota * Pregnant or lactating woman * Other conditions at investigator's discretion

Outcomes

Primary Outcomes

gut microbiota

Time frame: Change from Baseline Bacteroidetes abundances and composition of gut microbiota at 6 months

Secondary Outcomes

The improvement of intestinal microflora imbalance

Time frame: Bacteroidetes abundances and composition of gut microbiota (baseline, 4 weeks, 8 weeks and 12 weeks)

The change of inflammatory markers

The effect on plasma levels of inflammatory markers, such as IL-1B, IL-6 and TNF-α(baseline, 12 weeks)

Time frame: The change of inflammatory markers (baseline, 12 weeks)

Data from ClinicalTrials.gov

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