Effect of Gemigliptin on Metabolic Endotoxemia and Lipemia - Full Text View

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 Drug: Placebo


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:

MedlinePlus related topics: Diabetes Type 2

U.S. FDA Resources

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


Enrollment:	10
Study Start Date:	July 2014
Study Completion Date:	July 2015
Primary Completion Date:	July 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 Other Name: Zemiglo
Placebo Comparator: Placebo Placebo (identical in appearance to gemigliptin)	Drug: 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 (Adult, Senior)
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

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

More Information


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:	April 20, 2016
Health Authority:	South Korea: Ministry of Food and Drug Safety
Individual Participant Data
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

ClinicalTrials.gov processed this record on September 27, 2016