We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Usefulness of Postprandial Triglyceride for Assessment of Cardiovascular Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01972542
Recruitment Status : Completed
First Posted : October 30, 2013
Last Update Posted : October 27, 2015
Sponsor:
Information provided by (Responsible Party):
Soo Lim, Seoul National University Bundang Hospital

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.


Condition or disease Intervention/treatment
Diabetes Prediabetes Dietary Supplement: Oral fat tolerance test

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: The Usefulness of Postprandial Triglyceride for Assessment of Cardiovascular Risk in Healthy People, Impaired Glucose Tolerance and Type 2 Diabetes
Study Start Date : June 2013
Primary Completion Date : July 2015
Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 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

Dietary Supplement: Oral fat tolerance test
Active Comparator: Prediabetes

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
Sham Comparator: Normal glucose tolerance

Intervention : Oral fat tolerance test

No impaired fasting glucose and impaired glucose tolerance

Dietary Supplement: Oral fat tolerance test



Primary Outcome Measures :
  1. Changes of Triglyceride [ Time Frame: 8 hours ]
    Blood sample : drawn by a catheter before the meal and every 1 hour after meal over the 8-hour period


Secondary Outcome Measures :
  1. Changes of incretin [ Time Frame: 8 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972542


Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Soo Lim, MD, MPH, PhD Seoul National University Bundang Hospital

Responsible Party: Soo Lim, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01972542     History of Changes
Other Study ID Numbers: SNUBH-ENDO4
First Posted: October 30, 2013    Key Record Dates
Last Update Posted: October 27, 2015
Last Verified: October 2015

Keywords provided by Soo Lim, Seoul National University Bundang Hospital:
Postprandial period
triglyceride
Diabetes mellitus, type 2
Prediabetic state

Additional relevant MeSH terms:
Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases