Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT06761820
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-07
First Post:
2024-12-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect the Glycemic Control on Cardiac Function
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Evaluation the Effect of Glycemic Control on Cardiac Function in Patients with Type 2 Diabetes Mellitus
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluation of the effect of the Glycemic control on cardiac function in patients with type 2 diabetes mellitus
Detailed Description:
Type 2 Diabetes Mellitus (T2DM) is one of the most common metabolic disorders worldwide and its development is primarily caused by a combination of two main factors: defective insulin secretion by pancreatic β-cells and the inability of insulin-sensitive tissues to respond to insulin diabetes mellitus is a chronic, metabolic disease characterized by elevated levels of blood glucose, which leads over time to damage to the heart,vasculature, eyes, kidneys and nerves.
Over 90% of diabetes mellitus cases are T2DM, a conditionmarked by deficient insulin secretion by pancreatic islet β-cells, tissue insulin resistance (IR) and aninadequate compensatory insulin secretory response . Progression of the disease makes insulinsecretion unable to maintain glucose homeostasis, producing hyperglycaemia.
T2DM is a multisystem disease with a strong correlation with CVD development T2DM leads to a two- to four-fold increase in the mortality rate of adults from heart disease and is associated with both micro- and macro-vascular complications, the latter consisting of accelerated atherosclerosis leading to severe peripheral vascular disease, premature coronary artery disease (CAD) . These factors lead to T2DM being considered a significant risk factor for CVD \]. These include the role of IR in atherosclerosis, vascular function, oxidative stress, hypertension, macrophage accumulation and inflammation Factors implicated in cardiovascular risk outcomes from T2DM and the interactions between them. T2DM derived hyperglycemia, hyperinsulinemia and IR causes endothelial dysfunction, diabetic dyslipidemia and inflammation leading to atherosclerosis leading to CVD.
In addition, it is well documented that type 2 DM is associated with enhancement of platelet and hemostatic activities
Clinical trials have shown that intensive glucose control reduces the risk for microvascular complications among patients with type 2 diabetes, but its effect on CVD, including coronary heart disease (CHD), and peripheral arterial disease, is uncertain . Early data from the UKPDS (United Kingdom Prospective Diabetes Study) 34 suggested a protective effect of improved glucose control on CVD, CVD deaths, and all-causes mortality
Poor glycemic control and insulin resistance are associated with deterioration of heart failure and LV dysfunction . However, available data suggest no difference in the risk of worsening heart failure between subjecting patients to intensive glycemic control and standard treatment arms . The relationship between glycated hemoglobin (Hba1c) and LVEF remains unclear
Over 90% of diabetes mellitus cases are T2DM, a conditionmarked by deficient insulin secretion by pancreatic islet β-cells, tissue insulin resistance (IR) and aninadequate compensatory insulin secretory response . Progression of the disease makes insulinsecretion unable to maintain glucose homeostasis, producing hyperglycaemia.
T2DM is a multisystem disease with a strong correlation with CVD development T2DM leads to a two- to four-fold increase in the mortality rate of adults from heart disease and is associated with both micro- and macro-vascular complications, the latter consisting of accelerated atherosclerosis leading to severe peripheral vascular disease, premature coronary artery disease (CAD) . These factors lead to T2DM being considered a significant risk factor for CVD \]. These include the role of IR in atherosclerosis, vascular function, oxidative stress, hypertension, macrophage accumulation and inflammation Factors implicated in cardiovascular risk outcomes from T2DM and the interactions between them. T2DM derived hyperglycemia, hyperinsulinemia and IR causes endothelial dysfunction, diabetic dyslipidemia and inflammation leading to atherosclerosis leading to CVD.
In addition, it is well documented that type 2 DM is associated with enhancement of platelet and hemostatic activities
Clinical trials have shown that intensive glucose control reduces the risk for microvascular complications among patients with type 2 diabetes, but its effect on CVD, including coronary heart disease (CHD), and peripheral arterial disease, is uncertain . Early data from the UKPDS (United Kingdom Prospective Diabetes Study) 34 suggested a protective effect of improved glucose control on CVD, CVD deaths, and all-causes mortality
Poor glycemic control and insulin resistance are associated with deterioration of heart failure and LV dysfunction . However, available data suggest no difference in the risk of worsening heart failure between subjecting patients to intensive glycemic control and standard treatment arms . The relationship between glycated hemoglobin (Hba1c) and LVEF remains unclear
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: