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Clinical Trial Details

Trial ID: L2940
Source ID: NCT02186080
Associated Drug: Gemigliptin
Title: Effect of Gemigliptin on Metabolic Endotoxemia and Lipemia
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Gemigliptin|DRUG: Placebo
Outcome Measures: Primary: Difference between baseline and peak serum LPS, The increment of serum LPS after ingestion of high fat diet, serum LPS before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet | Secondary: Fasting serum LPS level, Compare fasting LPS level between treatment group, After 10 hrs of fasting|Incremental AUC of serum LPS during oral fat tolerance test, Calculated incremental AUC of serum LPS, serum LPS before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet|Difference between baseline and peak serum triglyceride level, The increment of serum TG after ingestion of high fat diet, serum TG before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet|Incremental AUC of serum triglyceride level during oral fat tolerance test, Calculated incremental AUC of serum TG, serum TG before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet|Difference between baseline and peak serum apolipoprotein-B48, The increment of serum apolipoprotein-B48 after ingestion of high fat diet, serum apolipoprotein-B48 before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet|Incremental AUC of serum apolipoprotein-B48 during oral fat tolerance test, Calculated incremental AUC of serum apolipoprotein-B48, serum apolipoprotein-B48 before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet|Serum level of inflammatory markers (CRP, TNF-alpha, IL-6), Compare serum level of inflammatory markers between treatment groups, After 10 hr of fasting|mRNA expression level of inflammatory markers in the adipose tissue, Compare mRNA expression level of inflammatory markers, After high fat diet ingestion
Sponsor/Collaborators: Sponsor: Seoul National University Hospital | Collaborators: LG Life Sciences
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 10
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2014-07
Completion Date: 2015-07
Results First Posted:
Last Update Posted: 2016-04-21
Locations: Seoul National University Hospital, Seoul, 110-744, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT02186080