Seum Bile Acid Profile in Type 2 Diabetes and Association Between Bile Cid Profile and Adipokine or Oxidative Stress

January 17, 2019 updated by: Yonsei University

"The goal of this work is to critically test the hypothesis that there exists a different profile of bile acids (BAs) in patient with type 2 diabetes mellitus (T2DM) compared with normal controls. Through confirmation of different profile of BAs in T2DM, investigator will suggest modulation of specific bile acids as a new possible treatment target in patients with T2DM. Investigator also expect the specific BAs signature will be used to screen T2DM before hyperglycemia.

In addition, investigator will evaluate the association between each BA species and serum total glucagon like peptide-1 (GLP-1) or fibroblast growth factor-19 (FGF-19) concentrations to determine if the specific BAs profile is related with total GLP-1 or FGF-19 concentration in serum. Investigatr also evaluates the correlation between each BA species and metabolic profiles and oxidative stress marker to find possible roles of each BA component in glucose metabolism.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

362

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects are recruited from either patients who visit out-patient clinics (Diabetes center in Severance hospital) or healthy volunteers.

Description

Inclusion Criteria:

  1. pre-diabetes 1. defined according to the ADA guideline (prediabetes definition) FPG 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L) (IFG) or 2-h PG in the 75-g OGTT 140 mg/dL (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L) (IGT) or A1C 5.7-6.4% (39-46 mmol/mol)
  2. type 2 diabetes 1. defined according to the ADA guideline (DM definition) FPG ≥126 mg/dL (7.0 mmol/L) or 2-h PG ≥200 mg/dL (11.1 mmol/L) in the 75-g OGTT or A1C ≥6.5% (48 mmol/mol) or In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥200 mg/dL (11.1 mmol/L) or 2. taking any anti-diabetic medications
  3. Normal control 1. should not be included in other groups as above and 2. not taking any medication related to diabetes and dyslipidemia and 3. BMI <25kg/m2

Exclusion Criteria:

  1. subjects who refused to agree with informed consents
  2. subjects with organ-transplantation
  3. pregnant women
  4. type 1 diabetes -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1) Normal control
metabolically healthy with no obesity
3) type 2 diabetes
defined in 'inclusion criteria'
2) prediabetes
defined in 'inclusion criteria'

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bile acid profile
Time Frame: 8h fasting blood sample
Bile acids profile to predict T2DM will be measured using high performance liquid chromatography-tandem mass spectrometry.
8h fasting blood sample

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2015

Primary Completion (Actual)

July 2, 2018

Study Completion (Actual)

July 2, 2018

Study Registration Dates

First Submitted

January 6, 2016

First Submitted That Met QC Criteria

January 7, 2016

First Posted (Estimate)

January 8, 2016

Study Record Updates

Last Update Posted (Actual)

January 22, 2019

Last Update Submitted That Met QC Criteria

January 17, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2015-0503

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no plan to share data

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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