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Evaluation of the Effect of Sitagliptin on Gut Microbiota in Patients With Newly Diagnosed Type 2 Diabetes

Sponsor
Second Affiliated Hospital of Soochow University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02900417
Collaborator
(none)
9
Enrollment
1
Arm
2
Duration (Months)

Study Details

Study Description

Brief Summary

The present study will recruit 9 newly diagnosed type 2 diabetic patient to receive sitagliptin 100mg daily for 12 weeks. The aim of this study was to investigate the composition of gut microbiota before and after the therapy of sitagliptin.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

The present study will included 9 newly diagnosed type 2 diabetic patient to receive sitagliptin 100mg daily for 12 weeks. These patients will receive 75g oral glucose tolerance test and fasting plasma glucose levels, lipids levels, fasting insulin levels and 2 hour post-load plasma glucose levels will be measured. Stool samples will be collected before the initiation of the use of sitagliptin. After 12 weeks, all patients will have fasting plasma glucose levels, lipids levels, fasting insulin levels tested. Stool samples will be collected again.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
9 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
Evaluation of the Effect of Sitagliptin on Gut Microbiota in Patients With Newly Diagnosed Type 2 Diabetes
Study Start Date :
Sep 1, 2016
Anticipated Primary Completion Date :
Nov 1, 2016
Anticipated Study Completion Date :
Nov 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: sitagliptin

All the patients will receive sitagliptin 100mg daily.

Drug: Sitagliptin
All the patients will receive sitagliptin 100mg daily
Other Names:
  • Sitagliptin phosphate (Januvia; Merck)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The changes of the composition of gut microbiota before and after the use of sitagliptin [12 weeks]

    Secondary Outcome Measures

    1. Changes of HbA1c levels [12 weeks]

    2. Changes of fasting plasma glucose levels, lipids levels and insulin sensitivity [12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Newly-diagnosed type 2 diabetic patients aged between 40-70 years
    Exclusion Criteria:

    • Any chronic disease (other than diabetes)

    • Alcohol consumption/smoking

    • Pregnancy/breastfeeding

    • The use of antibiotics, pro-prebiotics within 3 months

    • History of intestinal surgery

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Second Affiliated Hospital of Soochow University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ji Hu, MD.,PhD., Second Affiliated Hospital of Soochow University
    ClinicalTrials.gov Identifier:
    NCT02900417
    Other Study ID Numbers:
    • SecondSoochowU
    First Posted:
    Sep 14, 2016
    Last Update Posted:
    Sep 14, 2016
    Last Verified:
    Sep 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Ji Hu, MD.,PhD., Second Affiliated Hospital of Soochow University
    type 2 diabetes
    gut microbiota
    sitagliptin
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Sitagliptin Phosphate

    Study Results

    No Results Posted as of Sep 14, 2016