Evaluation of the Effect of Gemigliptin on Metabolic Endotoxemia and Lipemia Induced by High Fat Diet in Patients With Type 2 Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- Gemigliptin
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Seoul National University Hospital
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Difference between baseline and peak serum LPS
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
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
Arms & Interventions
Gemigliptin
Gemigliptin 50mg qd added to subjects current diabetes treatment
Intervention: Gemigliptin
Placebo
Placebo (identical in appearance to gemigliptin)
Intervention: Placebo
Outcomes
Primary Outcomes
Difference between baseline and peak 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
The increment of serum LPS after ingestion of high fat diet
Secondary Outcomes
- Fasting serum LPS level(After 10 hrs of fasting)
- Incremental AUC of serum LPS during oral fat tolerance test(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(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(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(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(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)(After 10 hr of fasting)
- mRNA expression level of inflammatory markers in the adipose tissue(After high fat diet ingestion)