Metagenomic Analysis of Human Gut Microbiota in Patients With Metabolic Diseases Including Diabetes.
Overview
- Phase
- Not Applicable
- Intervention
- Metformin
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Yonsei University
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Metagenomic profile change
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
normal group
normal group (without diabetes diagnosis/treatment and in normoglycemia
Intervention: Metformin
normal group
normal group (without diabetes diagnosis/treatment and in normoglycemia
Intervention: ezetimibe
prediabetes
high risk, impaired fasting glucose, impaired glucose tolerance
Intervention: Metformin
prediabetes
high risk, impaired fasting glucose, impaired glucose tolerance
Intervention: ezetimibe
drug naive type 2 diabetes
type 2 diabetes, anti-hypoglycemic drug naive
Intervention: Metformin
drug naive type 2 diabetes
type 2 diabetes, anti-hypoglycemic drug naive
Intervention: ezetimibe
type 2 diabetes with metformin monotherapy
type 2 diabetes with metformin monotherapy
Intervention: Metformin
type 2 diabetes with SGLT2 inhibitor monotherapy
type 2 diabetes with SGLT2 inhibitor monotherapy
Intervention: SGLT2 inhibitor
dyslipidemia with ezetimibe therapy
dyslipidemia with ezetimibe therapy
Intervention: ezetimibe
Outcomes
Primary Outcomes
Metagenomic profile change
Time Frame: 3 months (chronic effect)
Stool metagenomic profile change in acute and chronic phase
Secondary Outcomes
- blood glucose change(3 months)