Coronary Endothelial FunctionPhase 4NCT02584075
Evaluate the Effect of Exenatide Treatment on Coronary Artery Endothelial Function
A Phase 4 study testing Byetta (Exenatide) and Glucophage ( Metformin Hydrochloride) in people with Coronary Endothelial Function, run by Beijing Chao Yang Hospital.
Trial summary
Type 2 diabetes mellitus (T2DM) is an important risk factor of cardio-cerebral vascular disease such as coronary heart disease. GLP-1 is a kind of incretin secreted by the L-cell located in Ileum. It acts as an incretin hormone by protentiating glucose-stimulated insulin release. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Coronary Endothelial Function
- What is being tested?
- Byetta (Exenatide) and Glucophage ( Metformin Hydrochloride)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Jan 2018
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females or males, and aged 20 to 65 years
- Newly diagnose type 2 diabetes mellitus with BMI>25kg/m2.
- HbA1C>8%.
Who cannot join
- Type 1 diabetes mellitus, diabetic ketoacidosis, diabetic hyperosmolar coma.
- Hepatic insufficiency (ALT or AST> 1.5*ULN).
- Renal insufficiency [Creatinine clearance rate (Ccr)]<60ml/min estimated from MDRD equation).
- Thyroid disease
- Use of any anti-diabetic, anti-hypertension or anti-dyslipidemia drugs.
- Pregnant or lactating woman.
Show all 9Show fewer
- Severe anemia.
- Acute myocardial infarction or stoke.
- Other conditions at investigator's discretion.
About this study
Type 2 diabetes mellitus (T2DM) is an important risk factor of cardio-cerebral vascular disease such as coronary heart disease. GLP-1 is a kind of incretin secreted by the L-cell located in Ileum. It acts as an incretin hormone by protentiating glucose-stimulated insulin release. Recent studies reported that GLP-1 RA can protect the vascular endothelial and prevent vascular from atherosclerosis. Investigators design this study to investigate exenatide's effect on the improvement of the coronary endothelial function by evaluating endothelium dependent diastolic function and testing the vascular endothelial active substance and related inflammatory factors.
- Conditions
- Coronary Endothelial Function
- Being tested
- Byetta (Exenatide), Glucophage ( Metformin Hydrochloride)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Byetta (Exenatide)Drug
Exenatide treatment: 5 µg twice/day subcutaneous injection for 4 weeks, 10 µg twice/day subcutaneous injection for 8 weeks.
Glucophage ( Metformin Hydrochloride)Drug
Metformin 500mg Tid
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle intervention | Experimental | Not described Receives: Drug: Byetta (Exenatide); Drug: Glucophage ( Metformin Hydrochloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary endothelial function
the change of coronary flow velocity reserve (CFVR)(baseline, 12 weeks)
Measured: the change of coronary endothelial function(baseline, 12 weeks)
Secondary outcomes (6)
the changes of fasting plasma glucose (FPG)
the changes of fasting plasma glucose (FPG) (baseline, 12 weeks)
Measured: the changes of fasting plasma glucose (FPG)(baseline, 12 weeks)
the changes of HbA1C
the changes of HbA1C (baseline, 12 weeks)
Measured: the changes of HbA1C(baseline, 12 weeks)
the changes of fasting serum insulin (FINS)
the changes of fasting serum insulin (FINS) (baseline, 12 weeks)
Measured: the changes of fasting serum insulin (FINS) (baseline, 12 weeks)
the changes of IL-1B
the changes of IL-1B (baseline, 12 weeks)
Measured: the changes of IL-1B (baseline, 12 weeks)
the changes of IL-6
the changes of IL-6 (baseline, 12 weeks)
Measured: the changes of IL-6 (baseline, 12 weeks)
the changes of TNF-α
the changes of TNF-α(baseline, 12 weeks)
Measured: the changes of TNF-α(baseline, 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Endothelial FunctionStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guang Wang, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02584075
- Sponsor's protocol ID
- Exen100
- Status last verified
- Oct 2015
- First submitted
- 15 Oct 2015
- Last updated
- 22 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Effect of Exenatide Treatment on Coronary Artery Endothelial Function
- ClinicalTrials.gov ID
- NCT02584075
- Acronym / sponsor ID
- Exen100
- Conditions
- Coronary Endothelial Function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 22 Oct 2015 (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.
Type 2 diabetes mellitus (T2DM) is an important risk factor of cardio-cerebral vascular disease such as coronary heart disease. GLP-1 is a kind of incretin secreted by the L-cell located in Ileum. It acts as an incretin hormone by protentiating glucose-stimulated insulin release. Recent studies reported that GLP-1 RA can protect the vascular endothelial and prevent vascular from atherosclerosis. Investigators design this study to investigate exenatide's effect on the improvement of the coronary endothelial function by evaluating endothelium dependent diastolic function and testing the vascular endothelial active substance and related inflammatory factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention | Experimental | Drug: Byetta (Exenatide), Drug: Glucophage ( Metformin Hydrochloride) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Females or males, and aged 20 to 65 years
- Newly diagnose type 2 diabetes mellitus with BMI>25kg/m2.
- HbA1C>8%.
Key exclusion criteria (9 listed)
- Type 1 diabetes mellitus, diabetic ketoacidosis, diabetic hyperosmolar coma.
- Hepatic insufficiency (ALT or AST> 1.5*ULN).
- Renal insufficiency [Creatinine clearance rate (Ccr)]<60ml/min estimated from MDRD equation).
- Thyroid disease
- Use of any anti-diabetic, anti-hypertension or anti-dyslipidemia drugs.
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 |
|---|---|---|
| Byetta (Exenatide)Exenatide treatment: 5 µg twice/day subcutaneous injection for 4 weeks, 10 µg twice/day subcutaneous injection for 8 weeks. | Drug | Lifestyle intervention |
| Glucophage ( Metformin Hydrochloride)Metformin 500mg Tid | Drug | Lifestyle intervention |
Primary outcome
Coronary endothelial function
Time frame: the change of coronary endothelial function(baseline, 12 weeks)
the change of coronary flow velocity reserve (CFVR)(baseline, 12 weeks)
6 secondary outcomes
the changes of fasting plasma glucose (FPG)
Time frame: the changes of fasting plasma glucose (FPG)(baseline, 12 weeks)
the changes of HbA1C
Time frame: the changes of HbA1C(baseline, 12 weeks)
the changes of fasting serum insulin (FINS)
Time frame: the changes of fasting serum insulin (FINS) (baseline, 12 weeks)
the changes of IL-1B
Time frame: the changes of IL-1B (baseline, 12 weeks)
the changes of IL-6
Time frame: the changes of IL-6 (baseline, 12 weeks)
the changes of TNF-α
Time frame: the changes of TNF-α(baseline, 12 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2015.
Related trials for Coronary Endothelial Function
Not yet recruiting
Effect of Propionic Acid Supplementation on Endothelial Function
Cardiovascular Diseases, Endothelial Dysfunction
Not yet recruitingObservational study
Metabolic Changes in Heart Failure Patients Treated With Vericiguat
Heart Failure, Worsening Heart Failure
Enrolling by invitationObservational study
Blood Collection for Research Related to Certain Diseases Involving Blood Vessels
Sickle Cell Disease
RecruitingObservational study
Arterial Stiffness and Endothelial Function in Heart Failure
Heart Failure
Active, not recruiting
Sodium Lowering Vascular Effects Trial
Endothelial Dysfunction, Vascular Stiffness
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Byetta (Exenatide) and Glucophage ( Metformin Hydrochloride) in people with Coronary Endothelial Function, run by Beijing Chao Yang Hospital.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 22 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Coronary endothelial function (time frame: the change of coronary endothelial function(baseline, 12 weeks)). 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 22 Oct 2015.