Effect of Gemigliptin on Metabolic Endotoxemia and Lipemia

Seoul National University Hospital10 enrolled

Overview

This is an exploratory study on the metabolic endotoxemia associated with type 2 diabetes. The investigators will measure systemic endotoxin level and lipid level after ingestion of high fat diet to evaluate the effect of gemigliptin, a DPP-4 inhibitor, on metabolic endotoxemia and lipemia induced by high fat diet.

Study subjects will be allocated to either gemigliptin or placebo. After 4 weeks of treatment and 2 weeks of wash out period, all subjects will be switched to the opposite arm. The subjects will be tested oral fat tolerance test and adipose tissue needle biopsy(only for the subjects who agreed to participate donate adipose tissue) at 3 time points: the start of 1st treatment, end of 1st treatment and end of 2nd treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

GemigliptinDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age from 20 to 75 * At least 6 months from the diagnosis of type 2 diabetes * Current diabetes treatment: life style modification and/or metformin and/or sulfornylurea * No change of the diabetes treatment (drug number and dossage) in recent 3 months * HbA1c 6.5% to 10% Exclusion Criteria: * Recent cardiovascular event in 6 months * Concurrent use of statin or fibrate or ezetimibe * Renal failure, chronic liver disease * Pregnancy or lactation * Use of other DPP-4 inhibitor or GLP-1 analogue in recent 3 months

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Difference between baseline and peak serum LPS

The increment of serum LPS after ingestion of high fat diet

Time frame: serum LPS before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet

Secondary Outcomes

Fasting serum LPS level

Compare fasting LPS level between treatment group

Time frame: After 10 hrs of fasting

Incremental AUC of serum LPS during oral fat tolerance test

Calculated incremental AUC of serum LPS

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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