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

Obesity Clinical Trial

Official title:

Beijing Chao-yang Hospital, Capital Medical University

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02583438
• Other study ID #: Saxa015
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 14, 2015
• Last updated: October 21, 2015
• Start date: October 2015
• Est. completion date: January 2018

Study information

• Verified date: October 2015
• Source: Beijing Chao Yang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes

Intervention

Drug:
• Saxagliptin (Bristol-Myers Squibb Company)
6-month treatment of Saxagliptin 5mg Qd

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gut microbiota		Change from Baseline Bacteroidetes abundances and composition of gut microbiota at 6 months	Yes
Secondary	The improvement of intestinal microflora imbalance		Bacteroidetes abundances and composition of gut microbiota (baseline, 4 weeks, 8 weeks and 12 weeks)	Yes
Secondary	The change of inflammatory markers	The effect on plasma levels of inflammatory markers, such as IL-1B, IL-6 and TNF-a(baseline, 12 weeks)	The change of inflammatory markers (baseline, 12 weeks)	Yes