Evaluate the Effect of Saxagliptin on Gut Microbiota in P... | NCT02583438

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

NCT02583438

Sponsor

Beijing Chao Yang Hospital

Status

Unknown status

Last Update Posted

Oct 22, 2015Estimated

Enrollment

100Estimated

Phase

Phase 4

Conditions

Type 2 Diabetes
Obesity

Interventions

Saxagliptin (Bristol-Myers Squibb Company)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Oct 2017Estimated

Completion Date

Jan 2018Estimated

First Submitted Date

Oct 14, 2015

First Submission Date that Met QC Criteria

Oct 21, 2015

First Posted Date

Oct 22, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 21, 2015

Last Update Posted Date

Oct 22, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Guang Wang, Department of Endocrinology, Beijing Chao Yang HospitalPrincipal Investigator

Lead Sponsor

Beijing Chao Yang HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lifestyle intervention	Experimental		Drug: Saxagliptin (Bristol-Myers Squibb Company)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Saxagliptin (Bristol-Myers Squibb Company)	Drug	6-month treatment of Saxagliptin 5mg Qd	Lifestyle intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
gut microbiota		Change from Baseline Bacteroidetes abundances and composition of gut microbiota at 6 months

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D009765	Obesity

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C502994	saxagliptin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided