Gut Microbiota and Bile Acids in Type 2 Diabetes Mellitus

January 25, 2021 updated by: Chang Gung Memorial Hospital

Gut Microbiota and Bile Acids Mediate the Clinical Benefits of Metformin and YH1 in Patients With Treatment-naïve Type 2 Diabetes Mellitus: A Pilot Observational Study

The investigators will evaluate the stool microbiota, serum and fecal bile acid composition, and changes in blood glucose and lipid profile before and after one month of metformin or YH1 treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Outpatients and treatment-naïve male patients with type 2 diabetes

Description

Inclusion Criteria:

  1. Treatment-naïve male patients with type 2 diabetes;
  2. Aged 20-65 years;
  3. Body mass index (BMI) ≥ 24 kg/m2; 4.7 % ≤ glycated hemoglobin (HbA1c) < 9 %;

5.Low-density cholesterol (LDL-C) ≥ 130 mg/dl; 6.Expected to receive metformin 500 mg tid or YH1 6g tid for one month

Exclusion Criteria:

  1. type 1,or other specific types of diabetes;
  2. female;
  3. history of oral hypoglycemic agents (OHAs) treatment or insulin therapy;
  4. use of lipid-lowering drugs within the past six months;
  5. serious gastrointestinal (GI) tract diseases, including peptic ulcers and GI tract bleeding;
  6. hepatic insufficiency with ALT >72 U/L or renal insufficiency with an eGFR < 60 mL/min/1.73 m2;
  7. history of stressful situations, including diabetic ketoacidosis, nonketotic hyperosmolar diabetic coma, infectious disease, or surgery in the previous month;
  8. mental illness;
  9. current smoking status, alcohol or drug abuse;
  10. hemoglobin disease or chronic anemia;
  11. underlying conditions that could lead to poor compliance;
  12. severe organic diseases, including cancer, coronary heart disease, myocardial infarction or cerebrovascular disease;
  13. continuous antibiotic or probiotics use for over 3 days within 3 months prior to enrollment;
  14. continuous use of weight loss drug for over 1 month;
  15. history of YH1 therapy, or Chinese medicine treatment within the past one month.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
YH1 group
Drug: YH1
YH1 treatment for one month
Metformin group
Drug: metformin
metformin treatment for one month

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bile acid profile
Time Frame: one month
before and after YH1 or metformin treatment
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

December 9, 2019

First Submitted That Met QC Criteria

December 10, 2019

First Posted (Actual)

December 11, 2019

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201901022A3C601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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