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The Usefulness of Postprandial Triglyceride for Assessment of Cardiovascular Risk

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Seoul National University Bundang Hospital
Sponsor:
Information provided by (Responsible Party):
Soo Lim, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01972542
First received: October 23, 2013
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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 Intervention
Diabetes
Prediabetes
Dietary Supplement: Oral fat tolerance test

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Changes of Triglyceride [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: June 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01972542

Contacts
Contact: Soo Lim, MD, MPH, PhD +82-31-787-7035 limsoo@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Korea, Republic of, 463-707
Contact: Soo Lim, MD, MPH, PhD    +82-31-787-7035    limsoo@snu.ac.kr   
Principal Investigator: Soo Lim, MD, MPH, PhD         
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Soo Lim, MD, MPH, PhD Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Soo Lim, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01972542     History of Changes
Other Study ID Numbers: SNUBH-ENDO4
Study First Received: October 23, 2013
Last Updated: July 7, 2014
Health Authority: Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 27, 2014