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Effect of Gemigliptin on Metabolic Endotoxemia and Lipemia

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ClinicalTrials.gov Identifier: NCT02186080
Recruitment Status : Completed
First Posted : July 10, 2014
Last Update Posted : April 21, 2016
Sponsor:
Collaborator:
LG Life Sciences
Information provided by (Responsible Party):
Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Gemigliptin Drug: Placebo Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Gemigliptin
Gemigliptin 50mg qd added to subjects current diabetes treatment
Drug: Gemigliptin
Other Name: Zemiglo
Placebo Comparator: Placebo
Placebo (identical in appearance to gemigliptin)
Drug: Placebo



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Fasting serum LPS level [ Time Frame: After 10 hrs of fasting ]
    Compare fasting LPS level between treatment group

  2. 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 ]
    Calculated incremental AUC of serum LPS

  3. 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 ]
    The increment of serum TG after ingestion of high fat diet

  4. 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 ]
    Calculated incremental AUC of serum TG

  5. 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 ]
    The increment of serum apolipoprotein-B48 after ingestion of high fat diet

  6. 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 ]
    Calculated incremental AUC of serum apolipoprotein-B48

  7. Serum level of inflammatory markers (CRP, TNF-alpha, IL-6) [ Time Frame: After 10 hr of fasting ]
    Compare serum level of inflammatory markers between treatment groups

  8. mRNA expression level of inflammatory markers in the adipose tissue [ Time Frame: After high fat diet ingestion ]
    Compare mRNA expression level of inflammatory markers



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186080


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
LG Life Sciences
Investigators
Principal Investigator: Young Min Cho, MD, PhD Seoul National University Hospital

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02186080     History of Changes
Other Study ID Numbers: H-1401-089-550
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: July 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Endotoxemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Bacteremia
Sepsis
Infection
Toxemia
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes