The Usefulness of Postprandial Triglyceride for Assessmen... | NCT01972542

Studies
The Usefulness of Postprandial Triglyceride for Assessment of Cardiovascular Risk

NCT01972542

Sponsor

Seoul National University Bundang Hospital

Status

Completed

Last Update Posted

Oct 27, 2015Estimated

Enrollment

80Actual

Phase

Not Applicable

Conditions

Diabetes
Prediabetes

Interventions

Oral fat tolerance test

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Jul 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Oct 23, 2013

First Submission Date that Met QC Criteria

Oct 24, 2013

First Posted Date

Oct 30, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2015

Last Update Posted Date

Oct 27, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Soo Lim, Professor, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Type 2 DM	Active Comparator	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	Dietary Supplement: Oral fat tolerance test
Prediabetes	Active Comparator	Intervention : Oral fat tolerance test Glucose 140-199 mg/dL after 75g oral glucose tolerance test HbA1c 5.7-6.4%	Dietary Supplement: Oral fat tolerance test
Normal glucose tolerance	Sham Comparator	Intervention : Oral fat tolerance test No impaired fasting glucose and impaired glucose tolerance	Dietary Supplement: Oral fat tolerance test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral fat tolerance test	Dietary Supplement		Normal glucose tolerance Prediabetes Type 2 DM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
Changes of incretin		8 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Soo Lim, MD, MPH, PhD	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam		463-707	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D011236	Prediabetic State
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided