NCT01972542

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 30, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 27, 2015

Status Verified

October 1, 2015

Enrollment Period

2.1 years

First QC Date

October 23, 2013

Last Update Submit

October 23, 2015

Conditions

DiabetesPrediabetes

Keywords

Postprandial periodtriglycerideDiabetes mellitus, type 2Prediabetic state

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Changes of incretin

    8 hours

Study Arms (3)

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

Oral fat tolerance testDIETARY_SUPPLEMENT
Normal glucose tolerancePrediabetesType 2 DM

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age : 19 \~ 70 yrs
  • Type 2 diabetes : HbA1c \<10%
  • Prediabetic state : HbA1c 5.7\~6.4%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, 463-707, South Korea

Location

MeSH Terms

Conditions

Diabetes MellitusPrediabetic StateDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Soo Lim, MD, MPH, PhD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 23, 2013

First Posted

October 30, 2013

Study Start

June 1, 2013

Primary Completion

July 1, 2015

Study Completion

August 1, 2015

Last Updated

October 27, 2015

Record last verified: 2015-10

Locations

KR(1)