Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06557811
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Effect of Oral Semaglutide on Epicardial and Pericoronary Adipose Tissues in Type 2 Diabetes After Myocardial Infarction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Oral Semaglutide on Epicardial and Pericoronary Adipose Tissues in Type 2 Diabetes After Myocardial Infarction a Randomized and Double-blind Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SemaFatCard
Brief Summary:
The goal of this clinical trial is to investigate the ability of oral semaglutide to reduce pericardial and perivascular fat as well as coronary plaque in type 2 diabetic patients after acute myocardial infarction Patients of both sexes aged 50 years or older diagnosed with type 2 diabetes and with a previous acute myocardial infarction between more than 2 and less than 9 months ago will be included
The primary objective is to investigate the ability of oral semaglutide to reduce pericardial and perivascular fat in type 2 diabetics after myocardial infarction
The primary outcome will be composed of three measures
Measurement of pericardial adipose tissue at 180 days Measurement of the perivascular adipose tissue attenuation index at 180 days Measurement of the fat attenuation index at 180 days
To assess the degree of epicardial and perivascular fat attenuation coronary artery computed tomography will be performed and to evaluate the left ventricular ejection fraction transthoracic echocardiography will be conducted
Oral semaglutide may reduce pericardial andor perivascular fat in diabetics after acute myocardial infarction
The primary objective is to investigate the ability of oral semaglutide to reduce pericardial and perivascular fat in type 2 diabetics after myocardial infarction
The primary outcome will be composed of three measures
Measurement of pericardial adipose tissue at 180 days Measurement of the perivascular adipose tissue attenuation index at 180 days Measurement of the fat attenuation index at 180 days
To assess the degree of epicardial and perivascular fat attenuation coronary artery computed tomography will be performed and to evaluate the left ventricular ejection fraction transthoracic echocardiography will be conducted
Oral semaglutide may reduce pericardial andor perivascular fat in diabetics after acute myocardial infarction
Detailed Description:
TITLE Effect of Oral Semaglutide on Epicardial and Pericoronary Adipose Tissues in Type 2 Diabetic Patients After Myocardial Infarction
OBJECTIVE This randomized placebo-controlled study primarily aims to demonstrate the effect of oral semaglutide on pericardial and pericoronary adipose tissues atherosclerotic plaque and the vascular lumen in patients with T2D after myocardial infarction through CCT and CTA analysis with a secondary objective of analyzing anthropometric markers cardiac markers and insulin resistance
MATERIAL AND METHODS Equipment Cardiac Computed Tomography CCT and Echocardiography A standard CTA protocol using a 320 detector-row scanner Aquillion ONE Canon Medical Systems Ottawa Japan including coronary calcium score CCS and CTA will be performed To achieve a heart rate 65 bpm during acquisition patients will receive oral metoprolol 50-100 mg or intravenous metoprolol up to 15 mg in 5 mg increments Fast-acting sublingual nitrate 25-5 mg will also be administered to all patients before scanning After CCS acquisition ECG-triggered CTA will be performed with 70 mL of non-ionic contrast Iopromide 370 mg iodinemL Bayer Schering Pharma Berlin Germany injected intravenously at 50 mLs followed by 30-40 mL of saline The CTA parameters are as follows collimation 05 mm rotation time 400 ms tube voltage and current 100-120 kV and 250-550 mA adjusted to body mass index To be performed during Visits 1 and 2
Coronary Computed Tomography Angiography CTA in the proximal segment of the right coronary artery andor anterior descending coronary artery
Cardiac Markers Troponin I CK-MB C-Reactive Protein Interleukin 6
Metabolic Markers Measurement of neck circumference hepatic steatosis Abdominal Ultrasound Fasting Glycemia HbA1c Basal Insulin and HOMA-IR Cystatin C Total Cholesterol and Fractions Uric Acid TSH and Free T4
Anthropometric and Clinical Markers Body Weight Body Mass Index BMI weight height² Abdominal Waist AW AWHeight Ratio Blood Pressure and Heart Rate
STUDY DESIGN Prospective placebo-controlled double-blind single-center randomized study with 4 phases First phase Screening of chronic patients who had AMI with T2D for more than 1 month and less than 6 months in the InCor database according to inclusion criteria The patient will be called for Visit 1 inclusion If the screening is successful the patient will be fully informed about this study and will read and freely sign the Informed Consent Form ICF After this a clinical consultation will be conducted anthropometric data blood pressure and heart rate will be measured and the exams of CCT CTA Abdominal Ultrasound Echocardiography and other markers described will be ordered to enter the 1st phase of the study and receive randomized oral semaglutideplacebo treatment on the day of Visit 1 Randomization The start of randomization will be considered as day one The other phases will be counted from the start of randomization Phone calls during the 2nd and 3rd phases will ask the following questions 1 Is the patient using the medication correctly If not the patient will be invited for an extra visit 2 Is the patient experiencing any Adverse Events AE If yes the patient will be invited for an extra visit 4th Phase Visit 2 It will be asked if the patient used the medicationplacebo correctly if any AE occurred a clinical consultation will be conducted and the exams of CCT CTA Abdominal Ultrasound Echocardiography and other described markers will be ordered
STATISTICAL ANALYSIS Qualitative characteristics will be described according to the groups using absolute and relative frequencies and the association between groups will be verified at Visit 1 using chi-square tests or exact tests Quantitative characteristics will be described according to the groups using summary measures mean standard deviation median minimum and maximum and compared at baseline using Students t-test or Mann-Whitney tests according to the probability distribution of the data The characteristics of interest will be described according to the groups throughout the follow-up using summary measures and compared between groups and evaluation moments using generalized estimation equations with appropriate distributions and linkages followed by Bonferroni multiple comparisons when necessary IBM-SPSS for Windows version 220 software will be used for the analysis and Microsoft Excel 2010 software will be used for data tabulation Tests will be performed with a significance level of 5
OBJECTIVE This randomized placebo-controlled study primarily aims to demonstrate the effect of oral semaglutide on pericardial and pericoronary adipose tissues atherosclerotic plaque and the vascular lumen in patients with T2D after myocardial infarction through CCT and CTA analysis with a secondary objective of analyzing anthropometric markers cardiac markers and insulin resistance
MATERIAL AND METHODS Equipment Cardiac Computed Tomography CCT and Echocardiography A standard CTA protocol using a 320 detector-row scanner Aquillion ONE Canon Medical Systems Ottawa Japan including coronary calcium score CCS and CTA will be performed To achieve a heart rate 65 bpm during acquisition patients will receive oral metoprolol 50-100 mg or intravenous metoprolol up to 15 mg in 5 mg increments Fast-acting sublingual nitrate 25-5 mg will also be administered to all patients before scanning After CCS acquisition ECG-triggered CTA will be performed with 70 mL of non-ionic contrast Iopromide 370 mg iodinemL Bayer Schering Pharma Berlin Germany injected intravenously at 50 mLs followed by 30-40 mL of saline The CTA parameters are as follows collimation 05 mm rotation time 400 ms tube voltage and current 100-120 kV and 250-550 mA adjusted to body mass index To be performed during Visits 1 and 2
Coronary Computed Tomography Angiography CTA in the proximal segment of the right coronary artery andor anterior descending coronary artery
Cardiac Markers Troponin I CK-MB C-Reactive Protein Interleukin 6
Metabolic Markers Measurement of neck circumference hepatic steatosis Abdominal Ultrasound Fasting Glycemia HbA1c Basal Insulin and HOMA-IR Cystatin C Total Cholesterol and Fractions Uric Acid TSH and Free T4
Anthropometric and Clinical Markers Body Weight Body Mass Index BMI weight height² Abdominal Waist AW AWHeight Ratio Blood Pressure and Heart Rate
STUDY DESIGN Prospective placebo-controlled double-blind single-center randomized study with 4 phases First phase Screening of chronic patients who had AMI with T2D for more than 1 month and less than 6 months in the InCor database according to inclusion criteria The patient will be called for Visit 1 inclusion If the screening is successful the patient will be fully informed about this study and will read and freely sign the Informed Consent Form ICF After this a clinical consultation will be conducted anthropometric data blood pressure and heart rate will be measured and the exams of CCT CTA Abdominal Ultrasound Echocardiography and other markers described will be ordered to enter the 1st phase of the study and receive randomized oral semaglutideplacebo treatment on the day of Visit 1 Randomization The start of randomization will be considered as day one The other phases will be counted from the start of randomization Phone calls during the 2nd and 3rd phases will ask the following questions 1 Is the patient using the medication correctly If not the patient will be invited for an extra visit 2 Is the patient experiencing any Adverse Events AE If yes the patient will be invited for an extra visit 4th Phase Visit 2 It will be asked if the patient used the medicationplacebo correctly if any AE occurred a clinical consultation will be conducted and the exams of CCT CTA Abdominal Ultrasound Echocardiography and other described markers will be ordered
STATISTICAL ANALYSIS Qualitative characteristics will be described according to the groups using absolute and relative frequencies and the association between groups will be verified at Visit 1 using chi-square tests or exact tests Quantitative characteristics will be described according to the groups using summary measures mean standard deviation median minimum and maximum and compared at baseline using Students t-test or Mann-Whitney tests according to the probability distribution of the data The characteristics of interest will be described according to the groups throughout the follow-up using summary measures and compared between groups and evaluation moments using generalized estimation equations with appropriate distributions and linkages followed by Bonferroni multiple comparisons when necessary IBM-SPSS for Windows version 220 software will be used for the analysis and Microsoft Excel 2010 software will be used for data tabulation Tests will be performed with a significance level of 5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None