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

Phase 4

• Conditions: Type 2 Diabetes; Obesity
• Interventions: Drug: Saxagliptin (Bristol-Myers Squibb Company)

• Registration Number: NCT02583438
• Lead Sponsor: Beijing Chao Yang Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-10
• Study Start: 2015-10
• Study First Submitted: 2015-10-14
• Study First Submitted QC: 2015-10-21
• Last Update Submitted: 2015-10-21
• Study First Posted: 2015-10-22
• Last Update Posted: 2015-10-22
• Primary Completion: 2017-10
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lifestyle intervention	Saxagliptin (Bristol-Myers Squibb Company)	-

Primary Outcome Measures

Name	Time	Method
gut microbiota	Change from Baseline Bacteroidetes abundances and composition of gut microbiota at 6 months

Secondary Outcome Measures

Name	Time	Method
The improvement of intestinal microflora imbalance	Bacteroidetes abundances and composition of gut microbiota (baseline, 4 weeks, 8 weeks and 12 weeks)
The change of inflammatory markers	The change of inflammatory markers (baseline, 12 weeks)	The effect on plasma levels of inflammatory markers, such as IL-1B, IL-6 and TNF-α(baseline, 12 weeks)