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

Completed

• Conditions: Type 2 Diabetes; Prediabetes; Metabolic Syndrome; Non-alcoholic Fatty Liver Disease

• Registration Number: NCT02650830
• Lead Sponsor: Yonsei University

Brief Summary

"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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-12
• Study First Submitted: 2016-01-06
• Study First Submitted QC: 2016-01-07
• Study First Posted: 2016-01-08
• Primary Completion: 2018-07-02
• Study Completion: 2018-07-02
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-17
• Last Update Posted: 2019-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 362

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
bile acid profile	8h fasting blood sample	Bile acids profile to predict T2DM will be measured using high performance liquid chromatography-tandem mass spectrometry.

Trial Locations

Locations (1)

Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of