Type 2 Diabetes MellitusNCT03204799
Metagenomic Analysis of Human Gut Microbiota in Patients With Metabolic Diseases Including Diabetes
An observational study of Type 2 Diabetes Mellitus and Dyslipidemias, run by Yonsei University at 1 site in South Korea.
Trial summary
Microbiota is important for immunology, hormonal and metabolic homeostasis in human and could influence on developing diabetes and obesity. Recent studies investigates microbiota by metagenomic sequencing, however, the composite of microbiota and its metabolic role has not been fully determined. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Dyslipidemias
- What is being tested?
- Metformin, SGLT2 inhibitor and ezetimibe
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Dec 2016to 16 Dec 2019
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: type 2 diabetes patients with oral hypoglycemic agent/insulin naive
Who may be able to join
- normal group: body mass index [BMI]<23kg/m2, without diabetes mellitus history
- prediabetes group: fasting blood glucose ≥100 mg/dL and <126 mg/dL or postprandial blood glucose ≥140 mg/dL and <200 mg/dL
- type 2 diabetes according to ADA(American Diabetes Association) guideline (1) fasting blood glucose ≥126 mg/dL, (2) random blood glucose ≥200 mg/dL and with typical diabetes symptoms, (3) glycated hemoglobin A1c ≥6.5% and anti-hypoglycemic drug naive
- patients with type 2 diabetes, metformin monotherapy, SGLT2 inhibitor monotherapy
- patients with dyslipidemia, ezetimibe therapy
Who cannot join
- inflammatory bowel disease (Crohn's disease, ulcerative colitis)
- history of stomach, small intestine or colon resection operation
- on antibiotics therapy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University College of Medicine, Department of Internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes center
Seoul, 03722
Yong-ho Lee, M.D., Ph.D., 82-2-2228-1943, yholee@yuhs.ac
About this study
Official title: Metagenomic Analysis of Human Gut Microbiota in Patients With Metabolic Diseases Including Diabetes.
Microbiota is important for immunology, hormonal and metabolic homeostasis in human and could influence on developing diabetes and obesity. Recent studies investigates microbiota by metagenomic sequencing, however, the composite of microbiota and its metabolic role has not been fully determined. Metagenomics and microbiome analysis could early diagnose metabolic disorders and suggest treatment options for metabolic diseases.
In this study, the investigators investigate the composite of microbiota and deduct basic information for treatment models using metagenomic sequencing.
Read the detailed description
- Cross-section study: normal/prediabetes/drug naïve type2 diabetes: compare microbiota using metagenomic sequencing among three groups.
- Observational prospective study: metformin/sodium glucose co-transporter 2 (SGLT2) inhibitor/ezetimibe: compare microbiota using metagenomic sequencing before and after drug treatment.
- Conditions
- Type 2 Diabetes Mellitus, Dyslipidemias
- Being tested
- Metformin, SGLT2 inhibitor, ezetimibe
- Medical subject headings
- Diabetes Mellitus, Type 2, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminOther
newly diagnosed type 2 diabetes patients who start to metformin monotherapy
SGLT2 inhibitorDrug
newly diagnosed type 2 diabetes patients who start to SGLT2 inhibitor monotherapy
ezetimibeDrug
newly diagnosed dyslipidemia patients who start to ezetimibe therapy
| Study group | Role | What they receive |
|---|---|---|
| normal group | normal group (without diabetes diagnosis/treatment and in normoglycemia Receives: Other: Metformin; Drug: ezetimibe | |
| prediabetes | high risk, impaired fasting glucose, impaired glucose tolerance Receives: Other: Metformin; Drug: ezetimibe | |
| drug naive type 2 diabetes | type 2 diabetes, anti-hypoglycemic drug naive Receives: Other: Metformin; Drug: ezetimibe | |
| type 2 diabetes with metformin monotherapy | type 2 diabetes with metformin monotherapy Receives: Other: Metformin | |
| type 2 diabetes with SGLT2 inhibitor monotherapy | type 2 diabetes with SGLT2 inhibitor monotherapy Receives: Drug: SGLT2 inhibitor | |
| dyslipidemia with ezetimibe therapy | dyslipidemia with ezetimibe therapy Receives: Drug: ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metagenomic profile change
Stool metagenomic profile change in acute and chronic phase
Measured: 10 days (acute effect)
Metagenomic profile change
Stool metagenomic profile change in acute and chronic phase
Measured: 3 months (chronic effect)
Secondary outcomes (1)
blood glucose change
fasting blood glucose
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start17 Dec 2016
- Primary completionSep 2019 (estimated)
- Study completion16 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204799
- Sponsor's protocol ID
- 4-2016-0950
- Status last verified
- Jan 2019
- First submitted
- 28 Jun 2017
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metagenomic Analysis of Human Gut Microbiota in Patients With Metabolic Diseases Including Diabetes.
- ClinicalTrials.gov ID
- NCT03204799
- Acronym / sponsor ID
- 4-2016-0950
- Conditions
- Type 2 Diabetes Mellitus, Dyslipidemias
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 17 Dec 2016 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- 16 Dec 2019 (estimated)
- First posted
- 2 Jul 2017 (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.
Microbiota is important for immunology, hormonal and metabolic homeostasis in human and could influence on developing diabetes and obesity. Recent studies investigates microbiota by metagenomic sequencing, however, the composite of microbiota and its metabolic role has not been fully determined. Metagenomics and microbiome analysis could early diagnose metabolic disorders and suggest treatment options for metabolic diseases.
In this study, the investigators investigate the composite of microbiota and deduct basic information for treatment models using metagenomic sequencing.
Detailed description
- Cross-section study: normal/prediabetes/drug naïve type2 diabetes: compare microbiota using metagenomic sequencing among three groups.
- Observational prospective study: metformin/sodium glucose co-transporter 2 (SGLT2) inhibitor/ezetimibe: compare microbiota using metagenomic sequencing before and after drug treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| normal group | – | Other: Metformin, Drug: ezetimibenormal group (without diabetes diagnosis/treatment and in normoglycemia |
| prediabetes | – | Other: Metformin, Drug: ezetimibehigh risk, impaired fasting glucose, impaired glucose tolerance |
| drug naive type 2 diabetes | – | Other: Metformin, Drug: ezetimibetype 2 diabetes, anti-hypoglycemic drug naive |
| type 2 diabetes with metformin monotherapy | – | Other: Metformintype 2 diabetes with metformin monotherapy |
| type 2 diabetes with SGLT2 inhibitor monotherapy | – | Drug: SGLT2 inhibitortype 2 diabetes with SGLT2 inhibitor monotherapy |
| dyslipidemia with ezetimibe therapy | – | Drug: ezetimibedyslipidemia with ezetimibe therapy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- type 2 diabetes patients with oral hypoglycemic agent/insulin naive
Key inclusion criteria (5 listed)
- normal group: body mass index [BMI]<23kg/m2, without diabetes mellitus history
- prediabetes group: fasting blood glucose ≥100 mg/dL and <126 mg/dL or postprandial blood glucose ≥140 mg/dL and <200 mg/dL
- type 2 diabetes according to ADA(American Diabetes Association) guideline (1) fasting blood glucose ≥126 mg/dL, (2) random blood glucose ≥200 mg/dL and with typical diabetes symptoms, (3) glycated hemoglobin A1c ≥6.5% and anti-hypoglycemic drug naive
- patients with type 2 diabetes, metformin monotherapy, SGLT2 inhibitor monotherapy
- patients with dyslipidemia, ezetimibe therapy
Key exclusion criteria (3 listed)
- inflammatory bowel disease (Crohn's disease, ulcerative colitis)
- history of stomach, small intestine or colon resection operation
- on antibiotics therapy
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 |
|---|---|---|
| Metforminnewly diagnosed type 2 diabetes patients who start to metformin monotherapy | Other | drug naive type 2 diabetes, normal group, prediabetes, type 2 diabetes with metformin monotherapy |
| SGLT2 inhibitornewly diagnosed type 2 diabetes patients who start to SGLT2 inhibitor monotherapy | Drug | type 2 diabetes with SGLT2 inhibitor monotherapy |
| ezetimibenewly diagnosed dyslipidemia patients who start to ezetimibe therapy | Drug | drug naive type 2 diabetes, dyslipidemia with ezetimibe therapy, normal group, prediabetes |
Primary outcome
Metagenomic profile change
Time frame: 10 days (acute effect)
Stool metagenomic profile change in acute and chronic phase
Metagenomic profile change
Time frame: 3 months (chronic effect)
Stool metagenomic profile change in acute and chronic phase
1 secondary outcome
blood glucose change
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Individual participant dataSharing planned: No
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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 Type 2 Diabetes Mellitus and Dyslipidemias, run by Yonsei University at 1 site in South Korea.
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 5 inclusion and 3 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 10 Jan 2019. 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 South Korea. 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 Yong-ho Lee, M.D., Ph.D. (82-2-2228-1943, yholee@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metagenomic profile change (time frame: 10 days (acute effect)). The study lists 2 primary outcomes in all. 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 10 Jan 2019.