Effect of Gemigliptin on Metabolic Endotoxemia and Lipemia

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Placebo; Drug: Gemigliptin

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
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Gemigliptin; Gemigliptin 50mg qd added to subjects current diabetes treatment	Drug: Gemigliptin; Other Names: Zemiglo
PLACEBO_COMPARATOR: Placebo; Placebo (identical in appearance to gemigliptin)	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between baseline and peak serum LPS	The increment of serum LPS after ingestion of high fat diet	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 Measures

Outcome Measure	Measure Description	Time Frame
Fasting serum LPS level	Compare fasting LPS level between treatment group	After 10 hrs of fasting
Incremental AUC of serum LPS during oral fat tolerance test	Calculated incremental AUC of serum LPS	serum LPS before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet
Difference between baseline and peak serum triglyceride level	The increment of serum TG after ingestion of high fat diet	serum TG before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet
Incremental AUC of serum triglyceride level during oral fat tolerance test	Calculated incremental AUC of serum TG	serum TG before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet
Difference between baseline and peak serum apolipoprotein-B48	The increment of serum apolipoprotein-B48 after ingestion of high fat diet	serum apolipoprotein-B48 before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet
Incremental AUC of serum apolipoprotein-B48 during oral fat tolerance test	Calculated incremental AUC of serum apolipoprotein-B48	serum apolipoprotein-B48 before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet
Serum level of inflammatory markers (CRP, TNF-alpha, IL-6)	Compare serum level of inflammatory markers between treatment groups	After 10 hr of fasting
mRNA expression level of inflammatory markers in the adipose tissue	Compare mRNA expression level of inflammatory markers	After high fat diet ingestion

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: LG Life Sciences

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (ACTUAL): July 1, 2015
• Study Completion (ACTUAL): July 1, 2015

Study Registration Dates

• First Submitted: July 4, 2014
• First Submitted That Met QC Criteria: July 9, 2014
• First Posted (ESTIMATE): July 10, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): April 21, 2016
• Last Update Submitted That Met QC Criteria: April 20, 2016
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: diabetes mellitus; DPP-4 inhibitor; metabolic endotoxemia; gemigliptin
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Endocrine System Diseases; Sepsis; Bacteremia; Toxemia; Diabetes Mellitus; Diabetes Mellitus, Type 2; Endotoxemia
• Other Study ID Numbers: H-1401-089-550

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO