Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370247
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2023-11-07
Brief Title:
First-time Usage of SGLT2 Inhibitors in Type 2 Diabetic Patients Who Are Fasting During Ramadan Safety and Efficacy
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
First-time Usage of SGLT2 Inhibitors in Type 2 Diabetic Patients Who Are Fasting During Ramadan Safety and Efficacy
Status:
COMPLETED
Status Verified Date:
2024-04
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:
All healthy Muslim adults are required to observe the Ramadan fast which is one of Islams five pillars People with Type 2 Diabetes Mellitus frequently fast throughout Ramadan T2DM
Although fasting during Ramadan is said to have positive effects on diabetes patients such as a reduction in excess body weight and an improvement in lipid profile it can be linked to a slight increased risk for metabolic complications that need immediate attention such as hypoglycemia and hyperglycemia dehydration and diabetic ketoacidosis DKA The number of diabetics worldwide was projected to reach 537 million in 2021 Studies have shown that there are a rising number of people in this category and by 2045 there will be 738 million people worldwide who have diabetes Almost 150 million Muslims worldwide have diabetes and this number is progressively rising Research estimates that 118 million of these Muslims who have diabetes fast throughout Ramadan underscoring the need of choosing the best treatment strategy at this time Almost two-thirds of all Muslims with T2DMfast throughout the month of Ramadan according to studies from CREED Epidemiology of Diabetes and RamadanAccording to this the most recent study showed that 86 of patients with T2DMreported a fast for at least 2 weeks
Patient education which should cover information on risks lifestyle modifications glucose monitoring diet exercise and medication is a crucial component of managing diabetes during RamadanSeveral studies have demonstrated the effectiveness and safety of sodium glucose cotransporter 2 inhibitors SGLT2 I in T2DM patients who are fasting throughout Ramadan In individuals with T2DM SGLT2 inhibitors have shown to reduce cardiovascular events and slow the course of renal disease
In the literature published so far SGLT2i has shown lower rates of hypoglycemia and hypovolemia during fasting as compared to sulphonylureas SU
Although fasting during Ramadan is said to have positive effects on diabetes patients such as a reduction in excess body weight and an improvement in lipid profile it can be linked to a slight increased risk for metabolic complications that need immediate attention such as hypoglycemia and hyperglycemia dehydration and diabetic ketoacidosis DKA The number of diabetics worldwide was projected to reach 537 million in 2021 Studies have shown that there are a rising number of people in this category and by 2045 there will be 738 million people worldwide who have diabetes Almost 150 million Muslims worldwide have diabetes and this number is progressively rising Research estimates that 118 million of these Muslims who have diabetes fast throughout Ramadan underscoring the need of choosing the best treatment strategy at this time Almost two-thirds of all Muslims with T2DMfast throughout the month of Ramadan according to studies from CREED Epidemiology of Diabetes and RamadanAccording to this the most recent study showed that 86 of patients with T2DMreported a fast for at least 2 weeks
Patient education which should cover information on risks lifestyle modifications glucose monitoring diet exercise and medication is a crucial component of managing diabetes during RamadanSeveral studies have demonstrated the effectiveness and safety of sodium glucose cotransporter 2 inhibitors SGLT2 I in T2DM patients who are fasting throughout Ramadan In individuals with T2DM SGLT2 inhibitors have shown to reduce cardiovascular events and slow the course of renal disease
In the literature published so far SGLT2i has shown lower rates of hypoglycemia and hypovolemia during fasting as compared to sulphonylureas SU
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None