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

Yonsei University

Status: Unknown

Conditions: Dyslipidemias; Type 2 Diabetes Mellitus

Treatments: Drug: ezetimibe; Drug: SGLT2 inhibitor; Other: Metformin

Study type: Observational

Funder types: Other

Identifiers

NCT03204799

4-2016-0950

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

150 participants in 6 patient groups

normal group

Description:

normal group (without diabetes diagnosis/treatment and in normoglycemia

Treatment:

Drug: ezetimibe

Other: Metformin

prediabetes

Description:

high risk, impaired fasting glucose, impaired glucose tolerance

Treatment:

Drug: ezetimibe

Other: Metformin

drug naive type 2 diabetes

Description:

type 2 diabetes, anti-hypoglycemic drug naive

Treatment:

Drug: ezetimibe

Other: Metformin

type 2 diabetes with metformin monotherapy

Description:

type 2 diabetes with metformin monotherapy

Treatment:

Other: Metformin

type 2 diabetes with SGLT2 inhibitor monotherapy

Description:

type 2 diabetes with SGLT2 inhibitor monotherapy

Treatment:

Drug: SGLT2 inhibitor

dyslipidemia with ezetimibe therapy

Description:

dyslipidemia with ezetimibe therapy

Treatment:

Drug: ezetimibe