Type 2 Diabetes MellitusNCT02186080
Effect of Gemigliptin on Metabolic Endotoxemia and Lipemia
A study testing Gemigliptin in people with Type 2 Diabetes Mellitus, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Gemigliptin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Gemigliptin, Placebo
- Keywords
- diabetes mellitus, metabolic endotoxemia, gemigliptin, DPP-4 inhibitor
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemigliptinDrug
Also called Zemiglo
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Gemigliptin | Experimental | Gemigliptin 50mg qd added to subjects current diabetes treatment Receives: Drug: Gemigliptin |
| Placebo | Placebo comparator | Placebo (identical in appearance to gemigliptin) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between baseline and peak serum LPS
The increment of serum LPS after ingestion of high fat diet
Measured: serum LPS before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet
Secondary outcomes (8)
Fasting serum LPS level
Compare fasting LPS level between treatment group
Measured: After 10 hrs of fasting
Incremental AUC of serum LPS during oral fat tolerance test
Calculated incremental AUC of serum LPS
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: After 10 hr of fasting
mRNA expression level of inflammatory markers in the adipose tissue
Compare mRNA expression level of inflammatory markers
Measured: After high fat diet ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- LG Life Sciences
- Responsible party
- Sponsor
- Investigators
- Young Min Cho, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186080
- Sponsor's protocol ID
- H-1401-089-550
- Status last verified
- Jul 2014
- First submitted
- 4 Jul 2014
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Gemigliptin on Metabolic Endotoxemia and Lipemia Induced by High Fat Diet in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02186080
- Acronym / sponsor ID
- H-1401-089-550
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- diabetes mellitus, metabolic endotoxemia, gemigliptin, DPP-4 inhibitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- LG Life Sciences
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 10 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemigliptin | Experimental | Drug: GemigliptinGemigliptin 50mg qd added to subjects current diabetes treatment |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (identical in appearance to gemigliptin) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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%
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GemigliptinAlso: Zemiglo | Drug | Gemigliptin |
| Placebo | Drug | Placebo |
Primary outcome
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
8 secondary outcomes
Fasting serum LPS level
Time frame: After 10 hrs of fasting
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
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
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
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
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
Serum level of inflammatory markers (CRP, TNF-alpha, IL-6)
Time frame: After 10 hr of fasting
mRNA expression level of inflammatory markers in the adipose tissue
Time frame: After high fat diet ingestion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Min Cho, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gemigliptin in people with Type 2 Diabetes Mellitus, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2016.