Clinical trial NCT02186080: Effect of Gemigliptin on Metabolic Endotoxemia and Lipemia
Official title: Evaluation of the Effect of Gemigliptin on Metabolic Endotoxemia and Lipemia Induced by High Fat Diet in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes mellitus
metabolic endotoxemia
gemigliptin
DPP-4 inhibitor
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: LG Life Sciences
First posted: 2014-07-10
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference between baseline and peak serum LPS
timeFrame: 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:
measure: Fasting serum LPS level
timeFrame: After 10 hrs of fasting
measure: Incremental AUC of serum LPS during oral fat tolerance test
timeFrame: serum LPS before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet
measure: Difference between baseline and peak serum triglyceride level
timeFrame: serum TG before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet
measure: Incremental AUC of serum triglyceride level during oral fat tolerance test
timeFrame: serum TG before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet
measure: Difference between baseline and peak serum apolipoprotein-B48
timeFrame: serum apolipoprotein-B48 before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet
measure: Incremental AUC of serum apolipoprotein-B48 during oral fat tolerance test
timeFrame: serum apolipoprotein-B48 before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet
measure: Serum level of inflammatory markers (CRP, TNF-alpha, IL-6)
timeFrame: After 10 hr of fasting
measure: mRNA expression level of inflammatory markers in the adipose tissue
timeFrame: After high fat diet ingestion
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Young Min Cho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: