Evaluation of the Effect of Gemigliptin on Metabolic Endotoxemia and Lipemia Induced by High Fat Diet in Patients With Type 2 Diabetes
This study is not yet open for participant recruitment.
(see Contacts and Locations)
Verified July 2014 by Seoul National University Hospital
Sponsor:
Seoul National University Hospital
Collaborator:
LG Life Science
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT02186080
First received: July 4, 2014
Last updated: July 9, 2014
Last verified: July 2014
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes Mellitus |
Drug: Gemigliptin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Evaluation of the Effect of Gemigliptin on Metabolic Endotoxemia and Lipemia Induced by High Fat Diet in Patients With Type 2 Diabetes |
Resource links provided by NLM:
Further study details as provided by Seoul National University Hospital:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]The increment of serum LPS after ingestion of high fat diet
Secondary Outcome Measures:
- Fasting serum LPS level [ Time Frame: After 10 hrs of fasting ] [ Designated as safety issue: No ]Compare fasting LPS level between treatment group
- Incremental AUC of serum LPS during oral fat tolerance test [ 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 ] [ Designated as safety issue: No ]Calculated incremental AUC of serum LPS
- Difference between baseline and peak serum triglyceride level [ 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 ] [ Designated as safety issue: No ]The increment of serum TG after ingestion of high fat diet
- Incremental AUC of serum triglyceride level during oral fat tolerance test [ 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 ] [ Designated as safety issue: No ]Calculated incremental AUC of serum TG
- Difference between baseline and peak serum apolipoprotein-B48 [ 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 ] [ Designated as safety issue: No ]The increment of serum apolipoprotein-B48 after ingestion of high fat diet
- Incremental AUC of serum apolipoprotein-B48 during oral fat tolerance test [ 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 ] [ Designated as safety issue: No ]Calculated incremental AUC of serum apolipoprotein-B48
- Serum level of inflammatory markers (CRP, TNF-alpha, IL-6) [ Time Frame: After 10 hr of fasting ] [ Designated as safety issue: No ]Compare serum level of inflammatory markers between treatment groups
- mRNA expression level of inflammatory markers in the adipose tissue [ Time Frame: After high fat diet ingestion ] [ Designated as safety issue: No ]Compare mRNA expression level of inflammatory markers
| Estimated Enrollment: | 10 |
| Study Start Date: | July 2014 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Gemigliptin
Gemigliptin 50mg qd added to subjects current diabetes treatment
|
Drug: Gemigliptin |
| Placebo Comparator: Placebo |
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| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02186080
Please refer to this study by its ClinicalTrials.gov identifier: NCT02186080
Contacts
| Contact: Young Min Cho, MD, PhD | 82-2-2072-1965 | ymchomd@snu.ac.kr |
Locations
| Korea, Republic of | |
| Seoul National University Hospital | Not yet recruiting |
| Seoul, Korea, Republic of, 110-744 | |
| Contact: Young Min Cho, MD, PhD 82-2-2072-1965 ymchomd@snu.ac.kr | |
| Principal Investigator: Young Min Cho, MD, PhD | |
Sponsors and Collaborators
Seoul National University Hospital
LG Life Science
More Information
No publications provided
| Responsible Party: | Seoul National University Hospital |
| ClinicalTrials.gov Identifier: | NCT02186080 History of Changes |
| Other Study ID Numbers: | H-1401-089-550 |
| Study First Received: | July 4, 2014 |
| Last Updated: | July 9, 2014 |
| Health Authority: | South Korea: Ministry of Food and Drug Safety |
Keywords provided by Seoul National University Hospital:
|
diabetes mellitus metabolic endotoxemia gemigliptin DPP-4 inhibitor |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on February 27, 2015