Diabetes Mellitus, Type 2NCT04194515
Gut Microbiota and Bile Acids in Type 2 Diabetes Mellitus
An observational study of Diabetes Mellitus, Type 2 and Metformin, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, men only
- Conditions the study is for
- Diabetes Mellitus, Type 2, Metformin, YH1
- What is being tested?
- YH1 and metformin
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2020to 31 Dec 2021
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients and treatment-naïve male patients with type 2 diabetes
Who may be able to join
- 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 %;
- 5.Low-density cholesterol (LDL-C) ≥ 130 mg/dl; 6.Expected to receive metformin 500 mg tid or YH1 6g tid for one month
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, 333
Yueh-Hsiang Huang, MD, 886975360240, igighuang@gmail.com
About this study
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
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
- Being tested
- YH1, metformin
- Keywords
- Bile acid, Microbiota
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YH1Drug
YH1 treatment for one month
metforminDrug
metformin treatment for one month
| Study group | Role | What they receive |
|---|---|---|
| YH1 group | Not described Receives: Drug: YH1 | |
| Metformin group | Not described Receives: Drug: metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
bile acid profile
before and after YH1 or metformin treatment
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start1 Jan 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194515
- Sponsor's protocol ID
- 201901022A3C601
- Status last verified
- Jan 2021
- First submitted
- 9 Dec 2019
- Last updated
- 27 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04194515
- Acronym / sponsor ID
- 201901022A3C601
- Conditions
- Diabetes Mellitus, Type 2, Metformin, YH1
- Keywords
- Bile acid, Microbiota
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YH1 group | – | Drug: YH1 |
| Metformin group | – | Drug: metformin |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients and treatment-naïve male patients with type 2 diabetes
Key inclusion criteria (4 listed)
- 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 %;
- 5.Low-density cholesterol (LDL-C) ≥ 130 mg/dl; 6.Expected to receive metformin 500 mg tid or YH1 6g tid for one month
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YH1YH1 treatment for one month | Drug | YH1 group |
| metforminmetformin treatment for one month | Drug | Metformin group |
Primary outcome
bile acid profile
Time frame: one month
before and after YH1 or metformin treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Metformin, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yueh-Hsiang Huang, MD (+886975360240, igighuang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bile acid profile (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.