Back to resultsEffect of Gemigliptin on Metabolic Endotoxemia and Lipemia
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Gemigliptin
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Type 2 Diabetes Mellitus focused on measuring diabetes mellitus, metabolic endotoxemia, gemigliptin, DPP-4 inhibitor
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Gemigliptin
Placebo
Arm Description
Gemigliptin 50mg qd added to subjects current diabetes treatment
Placebo (identical in appearance to gemigliptin)
Outcomes
Primary Outcome Measures
Difference between baseline and peak serum LPS
The increment of serum LPS after ingestion of high fat diet
Secondary Outcome Measures
Fasting serum LPS level
Compare fasting LPS level between treatment group
Incremental AUC of serum LPS during oral fat tolerance test
Calculated incremental AUC of serum LPS
Difference between baseline and peak serum triglyceride level
The increment of serum TG after ingestion of high fat diet
Incremental AUC of serum triglyceride level during oral fat tolerance test
Calculated incremental AUC of serum TG
Difference between baseline and peak serum apolipoprotein-B48
The increment of serum apolipoprotein-B48 after ingestion of high fat diet
Incremental AUC of serum apolipoprotein-B48 during oral fat tolerance test
Calculated incremental AUC of serum apolipoprotein-B48
Serum level of inflammatory markers (CRP, TNF-alpha, IL-6)
Compare serum level of inflammatory markers between treatment groups
mRNA expression level of inflammatory markers in the adipose tissue
Compare mRNA expression level of inflammatory markers
Full Information
NCT ID
NCT02186080
First Posted
July 4, 2014
Last Updated
April 20, 2016
Sponsor
Seoul National University Hospital
Collaborators
LG Life Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02186080
Brief Title
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
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
Collaborators
LG Life Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
diabetes mellitus, metabolic endotoxemia, gemigliptin, DPP-4 inhibitor
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gemigliptin
Arm Type
Experimental
Arm Description
Gemigliptin 50mg qd added to subjects current diabetes treatment
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (identical in appearance to gemigliptin)
Intervention Type
Drug
Intervention Name(s)
Gemigliptin
Other Intervention Name(s)
Zemiglo
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Difference between baseline and peak serum LPS
Description
The increment of serum LPS after ingestion of high fat diet
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
Secondary Outcome Measure Information:
Title
Fasting serum LPS level
Description
Compare fasting LPS level between treatment group
Time Frame
After 10 hrs of fasting
Title
Incremental AUC of serum LPS during oral fat tolerance test
Description
Calculated incremental AUC of 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
Title
Difference between baseline and peak serum triglyceride level
Description
The increment of serum TG after ingestion of high fat diet
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
Title
Incremental AUC of serum triglyceride level during oral fat tolerance test
Description
Calculated incremental AUC of serum TG
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
Title
Difference between baseline and peak serum apolipoprotein-B48
Description
The increment of serum apolipoprotein-B48 after ingestion of high fat diet
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
Title
Incremental AUC of serum apolipoprotein-B48 during oral fat tolerance test
Description
Calculated incremental AUC of 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
Title
Serum level of inflammatory markers (CRP, TNF-alpha, IL-6)
Description
Compare serum level of inflammatory markers between treatment groups
Time Frame
After 10 hr of fasting
Title
mRNA expression level of inflammatory markers in the adipose tissue
Description
Compare mRNA expression level of inflammatory markers
Time Frame
After high fat diet ingestion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Min Cho, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Gemigliptin on Metabolic Endotoxemia and Lipemia
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