Effect of Gemigliptin on Metabolic Endotoxemia and Lipemia

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02186080
• Other study ID #: H-1401-089-550
• Status: Completed
• Phase: N/A
• First received: July 4, 2014
• Last updated: April 20, 2016
• Start date: July 2014
• Est. completion date: July 2015

Study information

• Verified date: July 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Endotoxemia
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Gemigliptin

• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	LG Life Sciences

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Fasting serum LPS level	Compare fasting LPS level between treatment group	After 10 hrs of fasting	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Serum level of inflammatory markers (CRP, TNF-alpha, IL-6)	Compare serum level of inflammatory markers between treatment groups	After 10 hr of fasting	No
Secondary	mRNA expression level of inflammatory markers in the adipose tissue	Compare mRNA expression level of inflammatory markers	After high fat diet ingestion	No