Myocardial Infarction Clinical Trial
Official title:
Effect of Dapagliflozin on the Progression From Prediabetes to T2DM in Subjects With Myocardial Infarction
It is hypothesize that, because dapagliflozin will reverse the metabolic defects responsible
for the development of prediabetes (i.e. insulin resistance and beta cell dysfunction) and
progression from prediabetes to T2DM (beta cell dysfunction) and will cause weight loss, it
will markedly reduce the progression from prediabetes to T2DM and reverse glucose tolerance
to NGT in patients with prediabetes experiencing acute myocardial infarction. Further, it is
hypothesized that the hemodynamic actions of dapagliflzoin will exert cardiovascular benefit
in subjects with prediabetes and acute MI by reducing cardiac remodeling, preserve LV
function and decrease the risk of development of heart failure and hospitalization for heart
failure.
Hence, aim to examine the impact of SGLT2 inhibitor on T2DM and cardiovascular risk in
patients with prediabetes and cardiovascular disease.
The primary objective of the study is to examine the effect of dapagliflozin (10 mg) on the
progression from prediabetes to T2DM in patients with prediabetes who experience acute
myocardial infarction (MI). A secondary objective is to examine the effect of dapagliflozin
on a composite of CV outcome including incidence and hospitalization for heart failure in
patients with prediabetes with acute MI. Other secondary outcome is the change from baseline
to end of study in LD systolic and diastolic function.
Status | Not yet recruiting |
Enrollment | 576 |
Est. completion date | January 31, 2021 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Acute MI according to AHA criteria 4 weeks prior to recruitment 2. eGFR >60 ml/min 3. stable body weight (+2 kg) in the preceding 3 months 4. diagnosis of prediabetes based upon the ADA criteria (FPG=100-125 mg/dl, and/or 2-hour plasma glucose=140-199 mg/dl Exclusion Criteria: 1. eGFR<60 ml/min 2. T2DM or T1DM according to the ADA criteria 3. Subjects receiving medications known to affect glucose tolerance 4. Pregnancy or lactation 5. Major organ disease like cancer, chronic pulmonary or liver disease |
Country | Name | City | State |
---|---|---|---|
Qatar | Heart Hospital, Hamad Medical Coorporation | Doha |
Lead Sponsor | Collaborator |
---|---|
Hamad Medical Corporation |
Qatar,
Abdul-Ghani M, Migahid O, Megahed A, Adams J, Triplitt C, DeFronzo RA, Zirie M, Jayyousi A. Combination Therapy With Exenatide Plus Pioglitazone Versus Basal/Bolus Insulin in Patients With Poorly Controlled Type 2 Diabetes on Sulfonylurea Plus Metformin: — View Citation
Abdul-Ghani M, Migahid O, Megahed A, Adams J, Triplitt C, DeFronzo RA, Zirie M, Jayyousi A. Erratum. Combination Therapy With Exenatide Plus Pioglitazone Versus Basal/Bolus Insulin in Patients With Poorly Controlled Type 2 Diabetes on Sulfonylurea Plus Me — View Citation
Abdul-Ghani M, Migahid O, Megahed A, Singh R, Kamal D, DeFronzo RA, Jayyousi A. Insulin secretion predicts the response to therapy with exenatide plus pioglitazone, but not to basal/bolus insulin in poorly controlled T2DM patients: Results from the Qatar — View Citation
Abdul-Ghani MA, DeFronzo RA. Pathophysiology of prediabetes. Curr Diab Rep. 2009 Jun;9(3):193-9. Review. — View Citation
Abdul-Ghani MA, Puckett C, Triplitt C, Maggs D, Adams J, Cersosimo E, DeFronzo RA. Initial combination therapy with metformin, pioglitazone and exenatide is more effective than sequential add-on therapy in subjects with new-onset diabetes. Results from th — View Citation
Abdul-Ghani MA, Tripathy D, DeFronzo RA. Contributions of beta-cell dysfunction and insulin resistance to the pathogenesis of impaired glucose tolerance and impaired fasting glucose. Diabetes Care. 2006 May;29(5):1130-9. Review. — View Citation
Al-Jobori H, Daniele G, Cersosimo E, Triplitt C, Mehta R, Norton L, DeFronzo RA, Abdul-Ghani M. Empagliflozin and Kinetics of Renal Glucose Transport in Healthy Individuals and Individuals With Type 2 Diabetes. Diabetes. 2017 Jul;66(7):1999-2006. doi: 10. — View Citation
Al-Lawati JA, Sulaiman KJ, Al-Zakwani I, Alsheikh-Ali AA, Panduranga P, Al-Habib KF, Al-Suwaidi J, Al-Mahmeed W, Al-Faleh H, El-Asfar A, Al-Motarreb A, Ridha M, Bulbanat B, Al-Jarallah M, Bazargani N, Asaad N, Amin H. Systolic Blood Pressure on Admission — View Citation
Dankner R, Abdul-Ghani MA, Gerber Y, Chetrit A, Wainstein J, Raz I. Predicting the 20-year diabetes incidence rate. Diabetes Metab Res Rev. 2007 Oct;23(7):551-8. — View Citation
Genuth S, Alberti KG, Bennett P, Buse J, Defronzo R, Kahn R, Kitzmiller J, Knowler WC, Lebovitz H, Lernmark A, Nathan D, Palmer J, Rizza R, Saudek C, Shaw J, Steffes M, Stern M, Tuomilehto J, Zimmet P; Expert Committee on the Diagnosis and Classification — View Citation
Lambers Heerspink HJ, de Zeeuw D, Wie L, Leslie B, List J. Dapagliflozin a glucose-regulating drug with diuretic properties in subjects with type 2 diabetes. Diabetes Obes Metab. 2013 Sep;15(9):853-62. doi: 10.1111/dom.12127. Epub 2013 Jun 5. — View Citation
Oliva RV, Bakris GL. Blood pressure effects of sodium-glucose co-transport 2 (SGLT2) inhibitors. J Am Soc Hypertens. 2014 May;8(5):330-9. doi: 10.1016/j.jash.2014.02.003. Epub 2014 Feb 12. Review. — View Citation
Sulaiman K, Panduranga P, Al-Zakwani I, Alsheikh-Ali AA, AlHabib KF, Al-Suwaidi J, Al-Mahmeed W, AlFaleh H, Elasfar A, Al-Motarreb A, Ridha M, Bulbanat B, Al-Jarallah M, Bazargani N, Asaad N, Amin H. Clinical characteristics, management, and outcomes of a — View Citation
Verma S, Garg A, Yan AT, Gupta AK, Al-Omran M, Sabongui A, Teoh H, Mazer CD, Connelly KA. Effect of Empagliflozin on Left Ventricular Mass and Diastolic Function in Individuals With Diabetes: An Important Clue to the EMPA-REG OUTCOME Trial? Diabetes Care. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence rate of T2DM | T2DM in Myocardial patients with prediabetes | 36 months |
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