Type 2 Diabetes Clinical Trial
— CATCH-EMOfficial title:
Stress Cardiac Magnetic Resonance of Asymptomatic Type 2 Diabetics With Cardiovascular High Risk to Measure Empagliflozin Impact on Myocardial Blood Flow (CATCH-EM)
The study design is a double blinded randomised control trial study that aims to conduct a randomised controlled trial of empagliflozin and determine if empagliflozin will improve myocardial blood flow in asymptomatic high risk type 2 diabetic patients. Also, to determine a cut-off using maximum upslope ratio and myocardial perfusion reserve index in which patients would demonstrate an improvement in myocardial blood flow.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | December 31, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 90 Years |
Eligibility | Inclusion Criteria: - Onset of type 2 diabetes at =30yrs old with no history of ketoacidosis - 40-90yrs old - Any 2 risk factors which include: i) Smoking (ie. current or ex-smokers) ii) Dyslipidaemia (defined as low density lipoprotein =2.6mmol/L, triglyceride >1.7mmol/L or decreased high density lipoprotein cholesterol <1.04mmol/L [man] or <1.29mmol/L [woman] or on lipid-lowering agent)(17, 18) iii) Hypertension (ie. systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg or patients treated for hypertension) iv) Obesity (using definition adapted for chinese ethnicity, body mass index >25kg/m2)(19) v) Family history of premature heart disease (defined as 1st degree relative [ie. parent or sibling] with development of atherosclerotic cardiovascular disease or cardiovascular related death <55 years of age in male and <65 years of age in female) - HbA1c = 6.5% and <10.0% Exclusion Criteria: - Angina pectoris or chest discomfort - Prior coronary artery bypass grafts - Coronary artery stenting within 6 months of study enrolment - Previous myocardial infarct - Any contraindication for stress CMR testing - Renal impairment with eGFR <45ml/min/1.73m2 - Limited life expectancy <5 years, for example due to pulmonary disease, cancer or significant hepatic failure - Contraindication to dual antiplatelet therapy - Contraindication to empagliflozin or other SGLT2 inhibitors - Unable to take empagliflozin - Patients currently on empagliflozin or given empagliflozin in the last 6 months - Planned need for concomitant cardiac surgery or coronary intervention - Refusal or inability to sign an informed consent. - Potential for non-compliance towards the requirements in the trial protocol (especially the medical treatment) or follow-up visits |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in myocardial blood flow as measured by stress CMR (ie. maximum upslope ratio and myocardial perfusion reserve index) between patients receiving empagliflozin and patients not receiving empagliflozin. | 36 months | ||
Primary | Cut-off value for maximum upslope ratio to predict =10% increase in myocardial blood flow as result of empagliflozin. | 36 months | ||
Primary | Cut-off value for myocardial perfusion index to predict =10% increase in myocardial blood flow as result of empagliflozin. | 36 months | ||
Secondary | Change in myocardial blood flow (MBF) in the intervention arm patients comparing patients with positive stress CMR to patients with negative stress CMR. | 36 months | ||
Secondary | Left ventricular ejection fraction. | 36 months | ||
Secondary | Left ventricular volumes. | 36 months | ||
Secondary | Left ventricular myocardial mass. | 36 months | ||
Secondary | Right ventricular ejection fraction. | 36 months | ||
Secondary | Right ventricular volumes. | 36 months | ||
Secondary | Right ventricular myocardial mass. | 36 months | ||
Secondary | Composite of empagliflozin therapy complication (eg. Urinary tract infection, acute renal failure). | 36 months | ||
Secondary | Progression in patient symptoms diagnoses. | The Seattle Angina Questionnaire (SAQ) will be administered at time of baseline CMR and at follow-up CMR in order to determine if there is an improvement in patient symptoms. | 36 months | |
Secondary | Improvement in exercise tolerance through performing a cardiopulmonary exercise test. | 36 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05219994 -
Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum
|
N/A | |
Completed |
NCT04056208 -
Pistachios Blood Sugar Control, Heart and Gut Health
|
Phase 2 | |
Completed |
NCT02284893 -
Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
|
Phase 3 | |
Completed |
NCT04274660 -
Evaluation of Diabetes and WELLbeing Programme
|
N/A | |
Active, not recruiting |
NCT05887817 -
Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR)
|
Phase 4 | |
Active, not recruiting |
NCT05566847 -
Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes
|
N/A | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Completed |
NCT04965506 -
A Study of IBI362 in Chinese Patients With Type 2 Diabetes
|
Phase 2 | |
Recruiting |
NCT06115265 -
Ketogenic Diet and Diabetes Demonstration Project
|
N/A | |
Active, not recruiting |
NCT03982381 -
SGLT2 Inhibitor or Metformin as Standard Treatment of Early Stage Type 2 Diabetes
|
Phase 4 | |
Completed |
NCT04971317 -
The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages
|
N/A | |
Completed |
NCT04496154 -
Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood
|
N/A | |
Completed |
NCT04023539 -
Effect of Cinnamomum Zeylanicum on Glycemic Levels of Adult Patients With Type 2 Diabetes
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Enrolling by invitation |
NCT05530356 -
Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
|
||
Completed |
NCT04097600 -
A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets
|
Phase 1 | |
Completed |
NCT03960424 -
Diabetes Management Program for Hispanic/Latino
|
N/A | |
Completed |
NCT05378282 -
Identification of Diabetic Nephropathy Biomarkers Through Transcriptomics
|
||
Active, not recruiting |
NCT06010004 -
A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes
|
Phase 3 | |
Completed |
NCT03653091 -
Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes
|
N/A |