Back to resultsThe Usefulness of Postprandial Triglyceride for Assessment of Cardiovascular Risk
Primary Purpose
Diabetes, Prediabetes
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Oral fat tolerance test
Sponsored by
About this trial
This is an interventional screening trial for Diabetes focused on measuring Postprandial period, triglyceride, Diabetes mellitus, type 2, Prediabetic state
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
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Sham Comparator
Arm Label
Type 2 DM
Prediabetes
Normal glucose tolerance
Arm Description
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
Intervention : Oral fat tolerance test Glucose 140-199 mg/dL after 75g oral glucose tolerance test HbA1c 5.7-6.4%
Intervention : Oral fat tolerance test No impaired fasting glucose and impaired glucose tolerance
Outcomes
Primary Outcome Measures
Changes of Triglyceride
Blood sample : drawn by a catheter before the meal and every 1 hour after meal over the 8-hour period
Secondary Outcome Measures
Changes of incretin
Full Information
NCT ID
NCT01972542
First Posted
October 23, 2013
Last Updated
October 23, 2015
Sponsor
Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01972542
Brief Title
The Usefulness of Postprandial Triglyceride for Assessment of Cardiovascular Risk
Official Title
The Usefulness of Postprandial Triglyceride for Assessment of Cardiovascular Risk in Healthy People, Impaired Glucose Tolerance and Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Prediabetes
Keywords
Postprandial period, triglyceride, Diabetes mellitus, type 2, Prediabetic state
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Type 2 DM
Arm Type
Active Comparator
Arm Description
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
Arm Title
Prediabetes
Arm Type
Active Comparator
Arm Description
Intervention : Oral fat tolerance test
Glucose 140-199 mg/dL after 75g oral glucose tolerance test HbA1c 5.7-6.4%
Arm Title
Normal glucose tolerance
Arm Type
Sham Comparator
Arm Description
Intervention : Oral fat tolerance test
No impaired fasting glucose and impaired glucose tolerance
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral fat tolerance test
Primary Outcome Measure Information:
Title
Changes of Triglyceride
Description
Blood sample : drawn by a catheter before the meal and every 1 hour after meal over the 8-hour period
Time Frame
8 hours
Secondary Outcome Measure Information:
Title
Changes of incretin
Time Frame
8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soo Lim, MD, MPH, PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
463-707
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Usefulness of Postprandial Triglyceride for Assessment of Cardiovascular Risk
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