Metagenomic Analysis of Human Gut Microbiota in Patients With Metabolic Diseases Including Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Metagenomic Analysis of Human Gut Microbiota in Patients With Metabolic Diseases Including Diabetes.

Conditions
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Type 2 Diabetes Mellitus, Dyslipidemias

Intervention / Treatment
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* Other: Metformin
* Drug: SGLT2 inhibitor
* Drug: ezetimibe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: inflammatory bowel disease (Crohn's disease, ulcerative colitis) history of stomach, small intestine or colon resection operation on antibiotics therapy

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| normal group<br>normal group (without diabetes diagnosis/treatment and in normoglycemia | Other: Metformin<br>* newly diagnosed type 2 diabetes patients who start to metformin monotherapy<br>Drug: ezetimibe<br>* newly diagnosed dyslipidemia patients who start to ezetimibe therapy<br>|
| prediabetes<br>high risk, impaired fasting glucose, impaired glucose tolerance | Other: Metformin<br>* newly diagnosed type 2 diabetes patients who start to metformin monotherapy<br>Drug: ezetimibe<br>* newly diagnosed dyslipidemia patients who start to ezetimibe therapy<br>|
| drug naive type 2 diabetes<br>type 2 diabetes, anti-hypoglycemic drug naive | Other: Metformin<br>* newly diagnosed type 2 diabetes patients who start to metformin monotherapy<br>Drug: ezetimibe<br>* newly diagnosed dyslipidemia patients who start to ezetimibe therapy<br>|
| type 2 diabetes with metformin monotherapy<br>type 2 diabetes with metformin monotherapy | Other: Metformin<br>* newly diagnosed type 2 diabetes patients who start to metformin monotherapy<br>|
| type 2 diabetes with SGLT2 inhibitor monotherapy<br>type 2 diabetes with SGLT2 inhibitor monotherapy | Drug: SGLT2 inhibitor<br>* newly diagnosed type 2 diabetes patients who start to SGLT2 inhibitor monotherapy<br>|
| dyslipidemia with ezetimibe therapy<br>dyslipidemia with ezetimibe therapy | Drug: ezetimibe<br>* newly diagnosed dyslipidemia patients who start to ezetimibe therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metagenomic profile change | Stool metagenomic profile change in acute and chronic phase | 10 days (acute effect) | 
| Metagenomic profile change | Stool metagenomic profile change in acute and chronic phase | 3 months (chronic effect) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood glucose change | fasting blood glucose | 3 months |