Dyslipidemias, Type 2 Diabetes Mellitus
Conditions
Brief 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. 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
1. Cross-section study: normal/prediabetes/drug naïve type2 diabetes: compare microbiota using metagenomic sequencing among three groups. 2. Observational prospective study: metformin/sodium glucose co-transporter 2 (SGLT2) inhibitor/ezetimibe: compare microbiota using metagenomic sequencing before and after drug treatment.
Interventions
OTHERMetformin
newly diagnosed type 2 diabetes patients who start to metformin monotherapy
DRUGSGLT2 inhibitor
newly diagnosed type 2 diabetes patients who start to SGLT2 inhibitor monotherapy
DRUGezetimibe
newly diagnosed dyslipidemia patients who start to ezetimibe therapy
Sponsors
Yonsei University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metagenomic profile change | 10 days (acute effect) | Stool metagenomic profile change in acute and chronic phase |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood glucose change | 3 months | fasting blood glucose |
Countries
South Korea
Contacts
Primary ContactYong-ho Lee, M.D., Ph.D.
Outcome results
None listed