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

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

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes Mellitus; Dyslipidemias
• Intervention / Treatment: Other: Metformin; Drug: ezetimibe; Drug: SGLT2 inhibitor

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Yonsei University College of Medicine, Department of internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes Center
    • Contact: Yong-ho Lee, M.D., Ph.D.; Phone Number: 82-2-2228-1943; Email: yholee@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

type 2 diabetes patients with oral hypoglycemic agent/insulin naive

Description

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 Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
normal group; normal group (without diabetes diagnosis/treatment and in normoglycemia	Other: Metformin; newly diagnosed type 2 diabetes patients who start to metformin monotherapy; Drug: ezetimibe; newly diagnosed dyslipidemia patients who start to ezetimibe therapy
prediabetes; high risk, impaired fasting glucose, impaired glucose tolerance	Other: Metformin; newly diagnosed type 2 diabetes patients who start to metformin monotherapy; Drug: ezetimibe; newly diagnosed dyslipidemia patients who start to ezetimibe therapy
drug naive type 2 diabetes; type 2 diabetes, anti-hypoglycemic drug naive	Other: Metformin; newly diagnosed type 2 diabetes patients who start to metformin monotherapy; Drug: ezetimibe; newly diagnosed dyslipidemia patients who start to ezetimibe therapy
type 2 diabetes with metformin monotherapy	Other: Metformin; newly diagnosed type 2 diabetes patients who start to metformin monotherapy
type 2 diabetes with SGLT2 inhibitor monotherapy	Drug: SGLT2 inhibitor; newly diagnosed type 2 diabetes patients who start to SGLT2 inhibitor monotherapy
dyslipidemia with ezetimibe therapy	Drug: ezetimibe; newly diagnosed dyslipidemia patients who start to ezetimibe therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metagenomic profile change	Stool metagenomic profile change in acute and chronic phase	10 days (acute effect)
Metagenomic profile change	Stool metagenomic profile change in acute and chronic phase	3 months (chronic effect)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood glucose change	fasting blood glucose	3 months

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2016
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): December 16, 2019

Study Registration Dates

• First Submitted: June 28, 2017
• First Submitted That Met QC Criteria: June 28, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): January 10, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Endocrine System Diseases; Lipid Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2; Dyslipidemias; Metabolic Diseases; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Metformin; Sodium-Glucose Transporter 2 Inhibitors; Ezetimibe
• Other Study ID Numbers: 4-2016-0950

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No