Gut Microbiota and Bile Acids in Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04194515
• Other study ID #: 201901022A3C601
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Metformin
• YH1

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