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

• Conditions: Type 2 Diabetes Mellitus; Dyslipidemias
• Interventions: Drug: SGLT2 inhibitor; Other: Metformin; Drug: ezetimibe

• Registration Number: NCT03204799
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study Start: 2016-12-17
• Study First Submitted: 2017-06-28
• Study First Submitted QC: 2017-06-28
• Study First Posted: 2017-07-02
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-08
• Last Update Posted: 2019-01-10
• Primary Completion: 2019-09
• Study Completion: 2019-12-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
type 2 diabetes with SGLT2 inhibitor monotherapy	SGLT2 inhibitor	type 2 diabetes with SGLT2 inhibitor monotherapy
drug naive type 2 diabetes	Metformin	type 2 diabetes, anti-hypoglycemic drug naive
type 2 diabetes with metformin monotherapy	Metformin	type 2 diabetes with metformin monotherapy
normal group	Metformin	normal group (without diabetes diagnosis/treatment and in normoglycemia
prediabetes	Metformin	high risk, impaired fasting glucose, impaired glucose tolerance
dyslipidemia with ezetimibe therapy	ezetimibe	dyslipidemia with ezetimibe therapy
normal group	ezetimibe	normal group (without diabetes diagnosis/treatment and in normoglycemia
prediabetes	ezetimibe	high risk, impaired fasting glucose, impaired glucose tolerance
drug naive type 2 diabetes	ezetimibe	type 2 diabetes, anti-hypoglycemic drug naive

Primary Outcome Measures

Name	Time	Method
Metagenomic profile change	3 months (chronic effect)	Stool metagenomic profile change in acute and chronic phase

Secondary Outcome Measures

Name	Time	Method
blood glucose change	3 months	fasting blood glucose

Trial Locations

Locations (1)

Yonsei University College of Medicine, Department of Internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes center; 🇰🇷 Seoul, Korea, Republic of