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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04194515
Other study ID # 201901022A3C601
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date December 31, 2021

Study information

Verified date January 2021
Source Chang Gung Memorial Hospital
Contact Yueh-Hsiang Huang, MD
Phone +886975360240
Email igighuang@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender Male
Age group 20 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
YH1
YH1 treatment for one month
metformin
metformin treatment for one month

Locations

Country Name City State
Taiwan Chang Gung Memorial Hospital Taoyuan

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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