Diabetic PatientsPhase 4SemaFatCardNCT06557811
Effect of Oral Semaglutide on Epicardial and Pericoronary Adipose Tissues in Type 2 Diabetes After Myocardial Infarction
A Phase 4 study testing Semaglutide in people with Diabetic Patients and Acute Myocardial Infarction, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Diabetic Patients, Acute Myocardial Infarction
- What is being tested?
- Semaglutide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2024to 1 Sep 2026
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient aged 50 years or older at the time of screening, diagnosed with type 2 diabetes and with a previous acute myocardial infarction more than 2 and less than 9 months ago, with the following conditions:
- Signed Informed Consent Form.
- BMI ≥ 25 and < 40 kg/m².
- The following glucose-lowering agents are permitted: any insulin, insulin analogs, sulfonylureas, meglitinides, biguanides, thiazolidinediones, alpha-glucosidase inhibitors, and SGLT-2 inhibitors (iSGLT2).
- Patients using iSGLT2 will not be excluded because they receive this medication at no cost at InCor with benefits for the treatment of type 2 diabetes. Furthermore, there would be an impact on ethical issues and the control of this prescription in other clinics. Thus, we will list the patients using SGLT2 inhibitors and statistically evaluate the comparison with the group that did not use this medication.
Who cannot join
- Patients with type 1 diabetes.
- Type 2 diabetes currently or previously treated (within 90 days prior to screening) with any GLP-1RA and DPP-4 inhibitor.
- Those not properly treated for previously diagnosed hypothyroidism.
- Diagnosed with NYHA class IV heart failure.
- Myocardial infarction more than 9 months after diagnosis.
- Any of the following: myocardial infarction, stroke, or hospitalization for unstable angina or transient ischemic attack within 60 days before screening.
Show all 19Show fewer
- Any contraindication present in the package insert for the use of GLP1-RA or Oral Semaglutide.
- Desire to become pregnant.
- Previous history of pancreatitis (acute or chronic).
- Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
- History of major surgical procedures involving the stomach, potentially affecting the absorption of the test product (e.g., subtotal and total gastrectomy, vertical gastrectomy, gastric bypass surgery).
- Planned and known coronary, carotid, or peripheral arterial revascularization on the day of screening.
- Chronic or intermittent hemodialysis, peritoneal dialysis, or severe renal insufficiency (corresponding to eGFR < 30 mL/min/1.73 m²) - due to CT specifications reported below.
- History or presence of malignant neoplasm in the last 5 years (except basal cell and squamous cell skin cancer and carcinoma in situ).
- History of diabetic ketoacidosis.
- Participation in another clinical trial investigating a drug.
- Participation in a clinical trial specifically evaluating stent(s) will be allowed.
- Uncontrolled systemic arterial hypertension with multiple antihypertensive agents.
- Any disorder that, in the opinion of the researcher, may compromise patient safety or protocol compliance.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
ARO (Academic Research Organization)
São Paulo, São Paulo, 05403-900
ARO InCor, 551126615795, aro@incor.usp.br
About this study
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
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.
Read more
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 and/or perivascular fat in diabetics after acute myocardial infarction.
Read the 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 (2.5-5 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 iodine/mL, Bayer Schering Pharma, Berlin, Germany), injected intravenously at 5.0 mL/s, followed by 30-40 mL of saline. The CTA parameters are as follows: collimation 0.5 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 and/or 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), AW/Height 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 semaglutide/placebo 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 medication/placebo 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 Student's 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 22.0 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%.
- Conditions
- Diabetic Patients, Acute Myocardial Infarction
- Being tested
- Semaglutide
- Keywords
- Diabetes, Acute myocardial infarction, Oral Semaglutide
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Also called Rybelsus
After randomization, each patient will receive four blisters of 3 mg tablets (semaglutide or placebo) and four blisters of 7 mg tablets (semaglutide or placebo), to be taken before breakfast. After 60 days, the patient will receive a 14 mg dose (a total of 16 blisters with 7 tablets each). The possibility of maintaining the 14 mg dose of the study drug or reducing it to 7 mg will be evaluated depending on side effects and tolerability.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Other | 2 groups: This group will receive semaglutide Receives: Drug: Semaglutide |
| Placebo | Other | 2 groups: This group will receive placebo (control population). Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of pericardial adipose tissue at 180 days
Measurement of pericardial adipose tissue (cm³)
Measured: 180 days
Measurement of the fat attenuation index at 180 days
Measurement of the fat attenuation index (Hounsfield units (HU))
Measured: 180 days
Measurement of the perivascular adipose tissue attenuation index at 180 days
Measurement of the perivascular adipose tissue attenuation index (Hounsfield units (HU))
Measured: 180 days
Secondary outcomes (23)
Determination of metabolic marker levels fasting blood glucose
Determination of metabolic marker level: fasting blood glucose (mg/dL)
Measured: 180 days
Determination of metabolic marker levels HbA1c
Determination of metabolic marker level: HbA1c (%)
Measured: 180 days
Determination of metabolic marker levels Insulin
Determination of metabolic marker level: Insulin (µU/mL)
Measured: 180 days
Determination of metabolic marker levels HOMA-IR
Determination of metabolic marker level:HOMA-IR
Measured: 180 days
Determination of metabolic marker levels total cholesterol and fractions
Determination of metabolic marker levels:total cholesterol and fractions (mg/dL)
Measured: 180 days
Determination of metabolic marker levels uric acid
Determination of metabolic marker levels:uric acid (mg/dL)
Measured: 180 days
Determination of metabolic marker levels TSH
Determination of metabolic marker levels:TSH (µUI/mL)
Measured: 180 days
Determination of metabolic marker levels free T4
Determination of metabolic marker levels: free T4 (ng/dL)
Measured: 180 days
Determination of complete blood count with platelet count
Determination of complete blood count: Hemoglobin (g/dL)
Measured: 180 days
Determination of complete blood count
Determination of complete blood count: Hematocrit (%)
Measured: 180 days
Determination of platelet count
Determination of platelet count (x10^3/µL)
Measured: 180 days
Determination of cardiac marker levels Troponin I
Measure of cardiac marker level: Troponin I (ng/mL)
Measured: 180 days
Determination of cardiac marker levels CK-MB
Measure of cardiac marker level: CK-MB (ng/mL)
Measured: 180 days
Determination of cardiac marker levels C-Reactive Protein
Measure of cardiac marker level: C-Reactive Protein (mg/L)
Measured: 180 days
Determination of cardiac marker levels Interleukin 6
Measure of cardiac marker level:Interleukin 6 (pg/mL)
Measured: 180 days
Determination of cardiac marker levels NT-proBNP
Measure of cardiac marker level: NT-proBNP (pg/mL)
Measured: 180 days
Determination of anthropometric measurements body mass index
Determination of anthropometric measurement: body mass index (kg/m2)
Measured: 180 days
Determination of anthropometric measurements Neck Circumference
Determination of anthropometric measurement: Neck Circumference (cm)
Measured: 180 days
Determination of anthropometric measurements Body Weight
Determination of anthropometric measurement: Body Weight (kg)
Measured: 180 days
Determination of anthropometric measurements Abdominal Waist
Determination of anthropometric measurement: Abdominal Waist (cm)
Measured: 180 days
Determination of anthropometric measurements Waist-to-Height Ratio
Determination of anthropometric measurement:Waist-to-Height Ratio
Measured: 180 days
Determination of anthropometric measurements Blood Pressure
Determination of anthropometric measurement: Blood Pressure (mmHg)
Measured: 180 days
Determination of anthropometric measurements Heart Rate
Determination of anthropometric measurement:Heart Rate (bpm)
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Diabetic PatientsStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Diabetic patients who suffered acute myocardial infarction will be divided into 2 groups, an arm that will receive medication and another arm placebo (control population).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Vicente Serrano Jr, University of Sao Paulo General Hospital
- Investigators
- Carlos V Serrano Junior, MD PHD, Principal investigator, InCOR- University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557811
- Sponsor's protocol ID
- 75667623.1.0000.0068
- Acronym
- SemaFatCard
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tsaban G, Wolak A, Avni-Hassid H, Gepner Y, Shelef I, Henkin Y, Schwarzfuchs D, Cohen N, Bril N, Rein M, Serfaty D, Kenigsbuch S, Tene L, Zelicha H, Yaskolka-Meir A, Komy O, Bilitzky A, Chassidim Y, Ceglarek U, Stumvoll M, Bluher M, Thiery J, Dicker D, Rudich A, Stampfer MJ, Shai I. Dynamics of intrapericardial and extrapericardial fat tissues during long-term, dietary-induced, moderate weight loss. Am J Clin Nutr. 2017 Oct;106(4):984-995. doi: 10.3945/ajcn.117.157115. Epub 2017 Aug 16.
PubMed 28814394Iacobellis G. Epicardial adipose tissue in endocrine and metabolic diseases. Endocrine. 2014 May;46(1):8-15. doi: 10.1007/s12020-013-0099-4. Epub 2013 Nov 23.
PubMed 24272604Lazaros G, Antonopoulos A, Antoniades C, Tousoulis D. The Role of Epicardial Fat in Pericardial Diseases. Curr Cardiol Rep. 2018 Apr 19;20(6):40. doi: 10.1007/s11886-018-0986-7.
PubMed 29675684Russo R, Di Iorio B, Di Lullo L, Russo D. Epicardial adipose tissue: new parameter for cardiovascular risk assessment in high risk populations. J Nephrol. 2018 Dec;31(6):847-853. doi: 10.1007/s40620-018-0491-5. Epub 2018 Apr 27.
PubMed 29704210Nagy E, Jermendy AL, Merkely B, Maurovich-Horvat P. Clinical importance of epicardial adipose tissue. Arch Med Sci. 2017 Jun;13(4):864-874. doi: 10.5114/aoms.2016.63259. Epub 2016 Oct 26.
PubMed 28721155Horckmans M, Bianchini M, Santovito D, Megens RTA, Springael JY, Negri I, Vacca M, Di Eusanio M, Moschetta A, Weber C, Duchene J, Steffens S. Pericardial Adipose Tissue Regulates Granulopoiesis, Fibrosis, and Cardiac Function After Myocardial Infarction. Circulation. 2018 Feb 27;137(9):948-960. doi: 10.1161/CIRCULATIONAHA.117.028833. Epub 2017 Nov 22.
PubMed 29167227Young LH, Viscoli CM, Curtis JP, Inzucchi SE, Schwartz GG, Lovejoy AM, Furie KL, Gorman MJ, Conwit R, Abbott JD, Jacoby DL, Kolansky DM, Pfau SE, Ling FS, Kernan WN; IRIS Investigators. Cardiac Outcomes After Ischemic Stroke or Transient Ischemic Attack: Effects of Pioglitazone in Patients With Insulin Resistance Without Diabetes Mellitus. Circulation. 2017 May 16;135(20):1882-1893. doi: 10.1161/CIRCULATIONAHA.116.024863. Epub 2017 Feb 28.
PubMed 28246237Kernan WN, Viscoli CM, Furie KL, Young LH, Inzucchi SE, Gorman M, Guarino PD, Lovejoy AM, Peduzzi PN, Conwit R, Brass LM, Schwartz GG, Adams HP Jr, Berger L, Carolei A, Clark W, Coull B, Ford GA, Kleindorfer D, O'Leary JR, Parsons MW, Ringleb P, Sen S, Spence JD, Tanne D, Wang D, Winder TR; IRIS Trial Investigators. Pioglitazone after Ischemic Stroke or Transient Ischemic Attack. N Engl J Med. 2016 Apr 7;374(14):1321-31. doi: 10.1056/NEJMoa1506930. Epub 2016 Feb 17.
PubMed 26886418Bouchi R, Terashima M, Sasahara Y, Asakawa M, Fukuda T, Takeuchi T, Nakano Y, Murakami M, Minami I, Izumiyama H, Hashimoto K, Yoshimoto T, Ogawa Y. Luseogliflozin reduces epicardial fat accumulation in patients with type 2 diabetes: a pilot study. Cardiovasc Diabetol. 2017 Mar 3;16(1):32. doi: 10.1186/s12933-017-0516-8.
PubMed 28253918Ascaso JF, Pardo S, Real JT, Lorente RI, Priego A, Carmena R. Diagnosing insulin resistance by simple quantitative methods in subjects with normal glucose metabolism. Diabetes Care. 2003 Dec;26(12):3320-5. doi: 10.2337/diacare.26.12.3320.
PubMed 14633821Bastarrika G, Broncano J, Schoepf UJ, Schwarz F, Lee YS, Abro JA, Costello P, Zwerner PL. Relationship between coronary artery disease and epicardial adipose tissue quantification at cardiac CT: comparison between automatic volumetric measurement and manual bidimensional estimation. Acad Radiol. 2010 Jun;17(6):727-34. doi: 10.1016/j.acra.2010.01.015. Epub 2010 Apr 3.
PubMed 20363161Hindso L, Jakobsen LS, Jacobsen C, Lynnerup N, Banner J. Epicardial adipose tissue volume estimation by postmortem computed tomography of eviscerated hearts. Forensic Sci Med Pathol. 2017 Dec;13(4):468-472. doi: 10.1007/s12024-017-9930-1. Epub 2017 Nov 2.
PubMed 29098638Oda S, Utsunomiya D, Funama Y, Yuki H, Kidoh M, Nakaura T, Takaoka H, Matsumura M, Katahira K, Noda K, Oshima S, Tokuyasu S, Yamashita Y. Effect of iterative reconstruction on variability and reproducibility of epicardial fat volume quantification by cardiac CT. J Cardiovasc Comput Tomogr. 2016 Mar-Apr;10(2):150-5. doi: 10.1016/j.jcct.2015.10.006. Epub 2015 Nov 3.
PubMed 26560351Ding X, Terzopoulos D, Diaz-Zamudio M, Berman DS, Slomka PJ, Dey D. Automated pericardium delineation and epicardial fat volume quantification from noncontrast CT. Med Phys. 2015 Sep;42(9):5015-26. doi: 10.1118/1.4927375.
PubMed 26328952Spearman JV, Renker M, Schoepf UJ, Krazinski AW, Herbert TL, De Cecco CN, Nietert PJ, Meinel FG. Prognostic value of epicardial fat volume measurements by computed tomography: a systematic review of the literature. Eur Radiol. 2015 Nov;25(11):3372-81. doi: 10.1007/s00330-015-3765-5. Epub 2015 Apr 30.
PubMed 25925354
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06557811
- Acronym / sponsor ID
- SemaFatCard / 75667623.1.0000.0068
- Conditions
- Diabetic Patients, Acute Myocardial Infarction
- Keywords
- Diabetes, Acute myocardial infarction, Oral Semaglutide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 16 Aug 2024 (actual)
- 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.
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 and/or 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 (2.5-5 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 iodine/mL, Bayer Schering Pharma, Berlin, Germany), injected intravenously at 5.0 mL/s, followed by 30-40 mL of saline. The CTA parameters are as follows: collimation 0.5 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 and/or 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), AW/Height 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 semaglutide/placebo 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 medication/placebo 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 Student's 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 22.0 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Diabetic patients who suffered acute myocardial infarction will be divided into 2 groups, an arm that will receive medication and another arm placebo (control population).
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Other | Drug: Semaglutide2 groups: This group will receive semaglutide |
| Placebo | Other | Drug: Semaglutide2 groups: This group will receive placebo (control population). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patient aged 50 years or older at the time of screening, diagnosed with type 2 diabetes and with a previous acute myocardial infarction more than 2 and less than 9 months ago, with the following conditions:
- Signed Informed Consent Form.
- BMI ≥ 25 and < 40 kg/m².
- The following glucose-lowering agents are permitted: any insulin, insulin analogs, sulfonylureas, meglitinides, biguanides, thiazolidinediones, alpha-glucosidase inhibitors, and SGLT-2 inhibitors (iSGLT2).
- Patients using iSGLT2 will not be excluded because they receive this medication at no cost at InCor with benefits for the treatment of type 2 diabetes. Furthermore, there would be an impact on ethical issues and the control of this prescription in other clinics. Thus, we will list the patients using SGLT2 inhibitors and statistically evaluate the comparison with the group that did not use this medication.
Key exclusion criteria (19 listed)
- Patients with type 1 diabetes.
- Type 2 diabetes currently or previously treated (within 90 days prior to screening) with any GLP-1RA and DPP-4 inhibitor.
- Those not properly treated for previously diagnosed hypothyroidism.
- Diagnosed with NYHA class IV heart failure.
- Myocardial infarction more than 9 months after diagnosis.
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 |
|---|---|---|
| SemaglutideAlso: RybelsusAfter randomization, each patient will receive four blisters of 3 mg tablets (semaglutide or placebo) and four blisters of 7 mg tablets (semaglutide or placebo), to be taken before breakfast. After 60 days, the patient will receive a 14 mg dose (a total of 16 blisters with 7 tablets each). The possibility of maintaining the 14 mg dose of the study drug or reducing it to 7 mg will be evaluated depending on side effects and tolerability. | Drug | Placebo, Semaglutide |
Primary outcome
Measurement of pericardial adipose tissue at 180 days
Time frame: 180 days
Measurement of pericardial adipose tissue (cm³)
Measurement of the fat attenuation index at 180 days
Time frame: 180 days
Measurement of the fat attenuation index (Hounsfield units (HU))
Measurement of the perivascular adipose tissue attenuation index at 180 days
Time frame: 180 days
Measurement of the perivascular adipose tissue attenuation index (Hounsfield units (HU))
23 secondary outcomes
Determination of metabolic marker levels fasting blood glucose
Time frame: 180 days
Determination of metabolic marker levels HbA1c
Time frame: 180 days
Determination of metabolic marker levels Insulin
Time frame: 180 days
Determination of metabolic marker levels HOMA-IR
Time frame: 180 days
Determination of metabolic marker levels total cholesterol and fractions
Time frame: 180 days
Determination of metabolic marker levels uric acid
Time frame: 180 days
Determination of metabolic marker levels TSH
Time frame: 180 days
Determination of metabolic marker levels free T4
Time frame: 180 days
Determination of complete blood count with platelet count
Time frame: 180 days
Determination of complete blood count
Time frame: 180 days
Determination of platelet count
Time frame: 180 days
Determination of cardiac marker levels Troponin I
Time frame: 180 days
Determination of cardiac marker levels CK-MB
Time frame: 180 days
Determination of cardiac marker levels C-Reactive Protein
Time frame: 180 days
Determination of cardiac marker levels Interleukin 6
Time frame: 180 days
Determination of cardiac marker levels NT-proBNP
Time frame: 180 days
Determination of anthropometric measurements body mass index
Time frame: 180 days
Determination of anthropometric measurements Neck Circumference
Time frame: 180 days
Determination of anthropometric measurements Body Weight
Time frame: 180 days
Determination of anthropometric measurements Abdominal Waist
Time frame: 180 days
Determination of anthropometric measurements Waist-to-Height Ratio
Time frame: 180 days
Determination of anthropometric measurements Blood Pressure
Time frame: 180 days
Determination of anthropometric measurements Heart Rate
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Background: PubMed 28814394Tsaban G, Wolak A, Avni-Hassid H, Gepner Y, Shelef I, Henkin Y, Schwarzfuchs D, Cohen N, Bril N, Rein M, Serfaty D, Kenigsbuch S, Tene L, Zelicha H, Yaskolka-Meir A, Komy O, Bilitzky A, Chassidim Y, Ceglarek U, Stumvoll M, Bluher M, Thiery J, Dicker D, Rudich A, Stampfer MJ, Shai I. Dynamics of intrapericardial and extrapericardial fat tissues during long-term, dietary-induced, moderate weight loss. Am J Clin Nutr. 2017 Oct;106(4):984-995. doi: 10.3945/ajcn.117.157115. Epub 2017 Aug 16.
- Background: PubMed 24272604Iacobellis G. Epicardial adipose tissue in endocrine and metabolic diseases. Endocrine. 2014 May;46(1):8-15. doi: 10.1007/s12020-013-0099-4. Epub 2013 Nov 23.
- Background: PubMed 29675684Lazaros G, Antonopoulos A, Antoniades C, Tousoulis D. The Role of Epicardial Fat in Pericardial Diseases. Curr Cardiol Rep. 2018 Apr 19;20(6):40. doi: 10.1007/s11886-018-0986-7.
- Background: PubMed 29704210Russo R, Di Iorio B, Di Lullo L, Russo D. Epicardial adipose tissue: new parameter for cardiovascular risk assessment in high risk populations. J Nephrol. 2018 Dec;31(6):847-853. doi: 10.1007/s40620-018-0491-5. Epub 2018 Apr 27.
- Background: PubMed 28721155Nagy E, Jermendy AL, Merkely B, Maurovich-Horvat P. Clinical importance of epicardial adipose tissue. Arch Med Sci. 2017 Jun;13(4):864-874. doi: 10.5114/aoms.2016.63259. Epub 2016 Oct 26.
- Background: PubMed 29167227Horckmans M, Bianchini M, Santovito D, Megens RTA, Springael JY, Negri I, Vacca M, Di Eusanio M, Moschetta A, Weber C, Duchene J, Steffens S. Pericardial Adipose Tissue Regulates Granulopoiesis, Fibrosis, and Cardiac Function After Myocardial Infarction. Circulation. 2018 Feb 27;137(9):948-960. doi: 10.1161/CIRCULATIONAHA.117.028833. Epub 2017 Nov 22.
- Background: PubMed 28246237Young LH, Viscoli CM, Curtis JP, Inzucchi SE, Schwartz GG, Lovejoy AM, Furie KL, Gorman MJ, Conwit R, Abbott JD, Jacoby DL, Kolansky DM, Pfau SE, Ling FS, Kernan WN; IRIS Investigators. Cardiac Outcomes After Ischemic Stroke or Transient Ischemic Attack: Effects of Pioglitazone in Patients With Insulin Resistance Without Diabetes Mellitus. Circulation. 2017 May 16;135(20):1882-1893. doi: 10.1161/CIRCULATIONAHA.116.024863. Epub 2017 Feb 28.
- Background: PubMed 26886418Kernan WN, Viscoli CM, Furie KL, Young LH, Inzucchi SE, Gorman M, Guarino PD, Lovejoy AM, Peduzzi PN, Conwit R, Brass LM, Schwartz GG, Adams HP Jr, Berger L, Carolei A, Clark W, Coull B, Ford GA, Kleindorfer D, O'Leary JR, Parsons MW, Ringleb P, Sen S, Spence JD, Tanne D, Wang D, Winder TR; IRIS Trial Investigators. Pioglitazone after Ischemic Stroke or Transient Ischemic Attack. N Engl J Med. 2016 Apr 7;374(14):1321-31. doi: 10.1056/NEJMoa1506930. Epub 2016 Feb 17.
- Background: PubMed 28253918Bouchi R, Terashima M, Sasahara Y, Asakawa M, Fukuda T, Takeuchi T, Nakano Y, Murakami M, Minami I, Izumiyama H, Hashimoto K, Yoshimoto T, Ogawa Y. Luseogliflozin reduces epicardial fat accumulation in patients with type 2 diabetes: a pilot study. Cardiovasc Diabetol. 2017 Mar 3;16(1):32. doi: 10.1186/s12933-017-0516-8.
- Background: PubMed 14633821Ascaso JF, Pardo S, Real JT, Lorente RI, Priego A, Carmena R. Diagnosing insulin resistance by simple quantitative methods in subjects with normal glucose metabolism. Diabetes Care. 2003 Dec;26(12):3320-5. doi: 10.2337/diacare.26.12.3320.
- Background: PubMed 20363161Bastarrika G, Broncano J, Schoepf UJ, Schwarz F, Lee YS, Abro JA, Costello P, Zwerner PL. Relationship between coronary artery disease and epicardial adipose tissue quantification at cardiac CT: comparison between automatic volumetric measurement and manual bidimensional estimation. Acad Radiol. 2010 Jun;17(6):727-34. doi: 10.1016/j.acra.2010.01.015. Epub 2010 Apr 3.
- Background: PubMed 29098638Hindso L, Jakobsen LS, Jacobsen C, Lynnerup N, Banner J. Epicardial adipose tissue volume estimation by postmortem computed tomography of eviscerated hearts. Forensic Sci Med Pathol. 2017 Dec;13(4):468-472. doi: 10.1007/s12024-017-9930-1. Epub 2017 Nov 2.
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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.
Carlos V Serrano Junior, MD PHD principal investigator
InCOR- University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide in people with Diabetic Patients and Acute Myocardial Infarction, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 19 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 26 Aug 2024. 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 Brazil. 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. 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?
Contact ARO InCOR HC FMUSP (551126615795, aro@incor.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of pericardial adipose tissue at 180 days (time frame: 180 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06557811, which also lists 22 linked publications.
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 26 Aug 2024.