Gut Microbiota and Bile Acids in Type 2 Diabetes Mellitus

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04194515

Enrollment

Registered

2019-12-11

Start date

2020-01-01

Completion date

2021-12-31

Last updated

2021-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Metformin, YH1

Keywords

Bile acid, Microbiota

Brief summary

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.

Interventions

DRUGYH1

YH1 treatment for one month

DRUGmetformin

metformin treatment for one month

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

20 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
bile acid profile	one month	before and after YH1 or metformin treatment

Countries

Taiwan

Contacts

Primary ContactYueh-Hsiang Huang, MD

igighuang@gmail.com+886975360240

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026