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

Type 2 Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02650830
• Other study ID #: 4-2015-0503
• Status: Completed
• Start date: September 12, 2015
• Est. completion date: July 2, 2018

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 362
• Est. completion date: July 2, 2018
• Est. primary completion date: July 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Fatty Liver
• Glucose Intolerance
• Liver Diseases
• Metabolic Syndrome
• Metabolic Syndrome X
• Non-alcoholic Fatty Liver Disease
• Prediabetes
• Prediabetic State
• Type 2 Diabetes

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University College of Medicine	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	bile acid profile	Bile acids profile to predict T2DM will be measured using high performance liquid chromatography-tandem mass spectrometry.	8h fasting blood sample