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NCT Number: NCT02186080

Effect of Gemigliptin on Metabolic Endotoxemia and Lipemia

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gemigliptin

Drug

Other names: Zemiglo

Placebo

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • LG Life Sciences

Registry information

Official study title

Evaluation of the Effect of Gemigliptin on Metabolic Endotoxemia and Lipemia Induced by High Fat Diet in Patients With Type 2 Diabetes

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 10, 2014
Registry last updated
Apr 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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