Coronary Microvascular Dysfunction Clinical Trial
Official title:
Effect of Intact GLP-1 (7-36) and GLP-1 Metabolite (9-36) on Coronary and Peripheral Vascular Function in Adults
Verified date | March 2019 |
Source | Bispebjerg Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
GLP-1 is an agent for treatment of type 2 diabetes and may have protective effects on the
cardiovascular system. The mechanism is complex and there seems to be a dual function with
intact GLP-1 (7-36), acting through the GLP-1 receptor, and the GLP-1 (9-36) metabolite
acting independently of the GLP-1 receptor.
Coronary flow reserve (CFR) is the ratio of flow through the coronary arteries during stress
to during rest and it reflects coronary microcirculation. Impaired CFR is a strong predictor
of poor prognosis of cardiovascular disease.
The aim of the study is to investigate the acute effects of GLP-1 on coronary
microcirculation and endothelial function in adults with obesity.
Status | Completed |
Enrollment | 25 |
Est. completion date | June 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 35 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Age 35-70 years - BMI > 25 kg/m2. - Central obesity (measured by waist circumference, defined as = 94cm for men and = 80 cm for women) - Non smokers (6 months abstinent is required) - Normal creatinine - For fertile women; negative pregnancy test and use of safe anticonception. - Speak and understand Danish or English - Mental ability to follow and understand the study Exclusion Criteria: - Known Diabetes - Known hypertension (untreated hypertension = 160/100 at inclusion is accepted) - Haemoglobin < 6.5 mmol/l - Allergy towards Januvia or Exenatide, Adenosin or Glycerylnitrate - Documented significant stenosis of the left anterior descending artery (LAD) at coronary angiography or CT-angiography or regional dysfunction documented during dipyridamol stress-echocardiography. If stress test at baseline shows significant stenosis the patient will be excluded from the study. - Pregnancy - Severe asthma - Active cancer, severe co-morbidity with limited life-expectancy, severe hepatic co-morbidity, chronic alcohol abuse, atrial fibrillation, chronic or previous acute pancreatitis, inflammatory bowel disease. |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Research in Endocrinology, Bispebjerg University Hospital | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Mette Zander | Hvidovre University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Coronary Flow Reserve | Coronary flow reserve (CFR) reflects microvessel coronary function and is the ratio between echocardiographic measured coronary flow velocity in LAD during adenosine induced myocardial hyperaemia and rest. The outcome is measured at every infusion/intervention (4 times). |
At baseline and after 2 hours of infusion | |
Secondary | Endothelial function (Assessed by Flow Mediated Dilation) | Assessed by Flow Mediated Dilation (FMD) The outcome is measured at every infusion/intervention (4 times). | At baseline and after 1 hour of infusion |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06306066 -
Coronary Thermo-dilution Derived Flow-indices in Chronic Coronary Syndrome
|
||
Recruiting |
NCT05288361 -
The DISCOVER INOCA Prospective Multi-center Registry
|
||
Terminated |
NCT04614467 -
A Placebo-Controlled Trial of CLBS16 in Subjects With Coronary Microvascular Dysfunction
|
Phase 2 | |
Recruiting |
NCT06089031 -
Belgian Registry on Coronary Function Testing
|
||
Enrolling by invitation |
NCT06083155 -
The NetherLands Registry of Invasive Coronary Vasomotor Function Testing (NL-CFT)
|
||
Completed |
NCT05009667 -
A Prospective, Multi-center Clinical Trial for Evaluating the Effectiveness and Safety of Online Coronary Angiography-Derived Index of Microcirculatory Resistance (caIMR)
|
||
Active, not recruiting |
NCT05197361 -
Microvascular Coronary Resistance and Absolute Coronary FLOW in Patients With Percutaneous Intervention of a Chronic Total Occlusion
|
||
Not yet recruiting |
NCT06332131 -
Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature
|
||
Recruiting |
NCT05825339 -
Absolute Flow for Ischemia With No Obstructive Coronary Arteries
|
||
Recruiting |
NCT05294887 -
Randomized Trial to Examine a Differential Therapeutic Response in Symptomatic Patients With Non-obstructive Coronary Artery Disease
|
Phase 4 | |
Not yet recruiting |
NCT05790876 -
Super Saturated Oxygen (SSO2) Therapy in Patients With ST-segment Elevation Myocardial Infarction (STEMI) and Action on Coronary Microcirculation Dysfunction
|
N/A | |
Completed |
NCT04959357 -
The Evaluation of Left Ventricular Systolic Function in Different Types of Ischemic Heart Disease
|
||
Recruiting |
NCT06393478 -
Southeastern Europe Microcirculation Registry
|
||
Completed |
NCT04523168 -
Feasibility and Efficacy of Coronary Sinus Narrowing in Patients With Coronary Microvascular Dysfunction
|
N/A | |
Recruiting |
NCT05711719 -
Vericiguat in Patients With Metabolic Syndrome and Coronary Vascular Dysfunction
|
Phase 2 | |
Recruiting |
NCT06294730 -
COronary Microcirculation and Troponin Elevation in Septic Shock
|
||
Recruiting |
NCT05841485 -
COVID-19 Microvascular Evaluation Trial
|
||
Recruiting |
NCT03876223 -
Women's Ischemia Syndrome Evaluation (WISE) Pre-HFpEF
|
||
Completed |
NCT05471739 -
Simultaneous Assessment of Coronary Microvascular Dysfunction and Ischemia With Non-obstructed Coronary Arteries With Intracoronary Electrocardiogram and Intracoronary Doppler
|
||
Completed |
NCT01014949 -
Microcirculation Assessment in Diabetes and Metabolic Syndrome
|
N/A |