Gut Microbiota and Bile Acids in Type 2 Diabetes Mellitus
NCT ID: NCT04194515
Last Updated: 2021-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
50 participants
OBSERVATIONAL
2020-01-01
2021-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Metagenomic Analysis of Human Gut Microbiota in Patients With Metabolic Diseases Including Diabetes
NCT03204799
The Alteration of Gut Microbiota and Analysis of Related Factors in Newly Diagnosed Type 2 Diabetes Patients
NCT05752851
Altered Faecal Microbiome and Metabolome in CT1D, AT1D and T2D
NCT05252728
Fecal Microbiota Transplantation on Type 2 Diabetes Mellitus
NCT01790711
Dissecting Host-microbiome Modifiers of Type 2 Diabetes Risk
NCT04579900
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
YH1 group
YH1
YH1 treatment for one month
Metformin group
metformin
metformin treatment for one month
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
YH1
YH1 treatment for one month
metformin
metformin treatment for one month
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
20 Years
65 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chang Gung Memorial Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
201901022A3C601
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.