Gut Microbiota and Bile Acids in Type 2 Diabetes Mellitus

NCT04194515 | Unknown

• 1 other identifier: 201901022A3C601
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Metformin; YH1

Keywords

Bile acid; Microbiota

Outcome Measures

Primary Outcomes (1)

• bile acid profile

  before and after YH1 or metformin treatment

  one month

Study Arms (2)

YH1 group

Drug: YH1

Metformin group

Drug: metformin

Interventions

YH1 DRUG

YH1 treatment for one month

YH1 group

metformin DRUG

metformin treatment for one month

Metformin group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients and treatment-naïve male patients with type 2 diabetes

You may qualify if:

• Treatment-naïve male patients with type 2 diabetes;
• Aged 20-65 years;
• Body mass index (BMI) ≥ 24 kg/m2; 4.7 % ≤ glycated hemoglobin (HbA1c) \< 9 %;
• Low-density cholesterol (LDL-C) ≥ 130 mg/dl; 6.Expected to receive metformin 500 mg tid or YH1 6g tid for one month

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Yueh-Hsiang Huang, MD

CONTACT

+886975360240; igighuang@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 11, 2019
• Study Start: January 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

TW (1)