The Usefulness of Postprandial Triglyceride for Assessment of Cardiovascular Risk

Diabetes Clinical Trial

Official title:

The Usefulness of Postprandial Triglyceride for Assessment of Cardiovascular Risk in Healthy People, Impaired Glucose Tolerance and Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01972542
• Other study ID #: SNUBH-ENDO4
• Status: Completed
• Phase: N/A
• First received: October 23, 2013
• Last updated: October 23, 2015
• Start date: June 2013
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The hypertriglyceridemia at fasting status has been known to be an important risk factor for cardiovascular disease (CVD). Recently, postprandial triglyceride (TG) levels draw an attention as a superior predictor of CVD because of non-fasting state for more than 12 hours and importance of triglyceride-rich lipoprotein.

We aim to investigate the relationship of postprandial triglyceride after fat tolerance test and intima-medial thickness and to suggest normal reference of postprandial triglyceride after fat tolerance test. In addition, we evaluate the correlation of postprandial triglyceride and incretin secretion after fat tolerance test Ultimately, we want to estimate clinical importance of postprandial triglyceride in assessment of cardiovascular risk.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

Inclusion Criteria:

• age : 19 ~ 70 yrs

• Type 2 diabetes : HbA1c <10%

• Prediabetic state : HbA1c 5.7~6.4%

Exclusion Criteria:

• Type 1 diabetes, secondary diabetes

• dipeptidyl peptidase-4 -inhibitor, glucagon-like peptide-1 agonist, thiazolidinediones users

• Thyroid disease with abnormal thyroid function test

• Liver disease with abnormal liver function test

• severe kidney disease

• pregnant or lactating women

• current smoker

• severe obesity

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Diabetes
• Prediabetes

Intervention

Dietary Supplement:
• Oral fat tolerance test

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Triglyceride	Blood sample : drawn by a catheter before the meal and every 1 hour after meal over the 8-hour period	8 hours	No
Secondary	Changes of incretin		8 hours	No