Gut Microbiota and Bile Acids in Type 2 Diabetes Mellitus

• Conditions: YH1; Diabetes Mellitus, Type 2; Metformin
• Interventions: Drug: YH1; Drug: metformin

• Registration Number: NCT04194515
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-11
• Study Start: 2020-01-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-01-27
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
YH1 group	YH1	-
Metformin group	metformin	-

Primary Outcome Measures

Name	Time	Method
bile acid profile	one month	before and after YH1 or metformin treatment

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan