Type 2 Diabetes Mellitus
Conditions
Keywords
diabetes mellitus, metabolic endotoxemia, gemigliptin, DPP-4 inhibitor
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.
Interventions
DRUGGemigliptin
DRUGPlacebo
Sponsors
LG Life Sciences
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference between baseline and peak 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 | The increment of serum LPS after ingestion of high fat diet |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Calculated incremental AUC of serum LPS |
| 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 | The increment of serum TG after ingestion of 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 | Calculated incremental AUC of serum TG |
| Fasting serum LPS level | After 10 hrs of fasting | Compare fasting LPS level between treatment group |
| Serum level of inflammatory markers (CRP, TNF-alpha, IL-6) | After 10 hr of fasting | Compare serum level of inflammatory markers between treatment groups |
| 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 | Calculated incremental AUC of serum apolipoprotein-B48 |
| mRNA expression level of inflammatory markers in the adipose tissue | After high fat diet ingestion | Compare mRNA expression level of inflammatory markers |
| 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 | The increment of serum apolipoprotein-B48 after ingestion of high fat diet |
Countries
South Korea
Outcome results
None listed