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

Primary Purpose

Type 2 Diabetes, Obesity

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Saxagliptin (Bristol-Myers Squibb Company)
Sponsored by
Beijing Chao Yang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Gut Microbiota, inflammatory marker, Glucose and lipid metabolism

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Lifestyle intervention

    Arm Description

    Outcomes

    Primary Outcome Measures

    gut microbiota

    Secondary Outcome Measures

    The improvement of intestinal microflora imbalance
    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)

    Full Information

    First Posted
    October 14, 2015
    Last Updated
    October 21, 2015
    Sponsor
    Beijing Chao Yang Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02583438
    Brief Title
    Evaluate the Effect of Saxagliptin on Gut Microbiota in Patients With Newly Diagnosed Type 2 Diabetes
    Official Title
    Beijing Chao-yang Hospital, Capital Medical University
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2015 (undefined)
    Primary Completion Date
    October 2017 (Anticipated)
    Study Completion Date
    January 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Beijing Chao Yang Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes, Obesity
    Keywords
    Gut Microbiota, inflammatory marker, Glucose and lipid metabolism

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Lifestyle intervention
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Saxagliptin (Bristol-Myers Squibb Company)
    Intervention Description
    6-month treatment of Saxagliptin 5mg Qd
    Primary Outcome Measure Information:
    Title
    gut microbiota
    Time Frame
    Change from Baseline Bacteroidetes abundances and composition of gut microbiota at 6 months
    Secondary Outcome Measure Information:
    Title
    The improvement of intestinal microflora imbalance
    Time Frame
    Bacteroidetes abundances and composition of gut microbiota (baseline, 4 weeks, 8 weeks and 12 weeks)
    Title
    The change of inflammatory markers
    Description
    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)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

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

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