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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03204799
• Other study ID #: 4-2016-0950
• Status: Recruiting
• Start date: December 17, 2016
• Est. completion date: December 16, 2019

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: Yong-ho Lee, M.D., Ph.D.
• Phone: 82-2-2228-1943
• Email: yholee[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 16, 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Dyslipidemias
• Metabolic Diseases
• Type 2 Diabetes Mellitus

Intervention

Other:
• Metformin
newly diagnosed type 2 diabetes patients who start to metformin monotherapy

Drug:
• SGLT2 inhibitor
newly diagnosed type 2 diabetes patients who start to SGLT2 inhibitor monotherapy
• ezetimibe
newly diagnosed dyslipidemia patients who start to ezetimibe therapy

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University College of Medicine, Department of Internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metagenomic profile change	Stool metagenomic profile change in acute and chronic phase	10 days (acute effect)
Primary	Metagenomic profile change	Stool metagenomic profile change in acute and chronic phase	3 months (chronic effect)
Secondary	blood glucose change	fasting blood glucose	3 months