The Usefulness of Postprandial Triglyceride for Assessment of Cardiovascular Risk

NCT ID: NCT01972542

Last Updated: 2015-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Prediabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Type 2 DM

Intervention : Oral fat tolerance test

well or moderately controlled type 2 diabetes mellitus (HbA1c \< 10%) No dipeptidyl peptidase-4 -inhibitor, Glucagon-like peptide-1 agonist, thiazolidinediones

Group Type ACTIVE_COMPARATOR

Oral fat tolerance test

Intervention Type DIETARY_SUPPLEMENT

Prediabetes

Intervention : Oral fat tolerance test

Glucose 140-199 mg/dL after 75g oral glucose tolerance test HbA1c 5.7-6.4%

Group Type ACTIVE_COMPARATOR

Oral fat tolerance test

Intervention Type DIETARY_SUPPLEMENT

Normal glucose tolerance

Intervention : Oral fat tolerance test

No impaired fasting glucose and impaired glucose tolerance

Group Type SHAM_COMPARATOR

Oral fat tolerance test

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Oral fat tolerance test

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo Lim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Soo Lim, MD, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SNUBH-ENDO4

Identifier Type: -

Identifier Source: org_study_id

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