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:
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
  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

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, Type 2
Diabetes Mellitus
Endotoxemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Bacteremia
Sepsis
Infection
Toxemia
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014