Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| LG Life Sciences | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemigliptin | Experimental | Gemigliptin 50mg qd added to subjects current diabetes treatment |
|
| Placebo | Placebo Comparator | Placebo (identical in appearance to gemigliptin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemigliptin | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Young Min Cho, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C534891 | LC15-0444 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| 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 |