Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528002
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Hybrid Method Between Low-ratio Premixed Insulin and Short Acting Insulin in Fasting Type 2 Diabetic Patients in Ramadan
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Hybrid Method Between Low-ratio Premixed Insulin and Short Acting Insulin in Fasting Type 2 Diabetic Patients in Ramadan Safety and Efficacy
Status:
COMPLETED
Status Verified Date:
2024-07
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:
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 MellitusT2DM frequently fast throughout Ramadan However many Muslim patients insist on fasting in spite of medical warning So the investigators aim in the current study to assess safety and efficacy of our hybrid method using of low-ratio premixed insulin take at Iftar and short acting insulin take at Suhoor compare to last recommendation of IDF guideline of using low-ratio premix insulin regimens in type 2 diabetic patients who insist on Ramadan fasting
Detailed Description:
All healthy Muslim adults are required to observe the Ramadan fast which is one of Islams five pillars People with Type 2 Diabetes MellitusT2DM frequently fast throughout Ramadan
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
Similarly an increase in hyperglycemic episodes was also noted in another study conducted by the Benghazi Diabetes and Endocrine Centre BDEC on 493 T2DM patients fasting during Ramadan where 107 experienced hyperglycemia Therefore appropriate treatment adjustments including insulin regimen are necessary to avoid both hypo and hyperglycemia during Ramadan fasting
T2DM patients well-controlled on premixed insulin or multiple doses injections should not fast and they have the legitimate exemption for this However many Muslim patients insist on fasting inspite of medical warning So the investigators aim in the current study to assess safety and efficacy of our hybrid method using of low-ratio premixed insulin take at Iftar and short acting insulin take at Suhoor compare to last recommendation of IDF guideline of using low-ratio premix insulin regimens in type 2 diabetic patients who insist on Ramadan fasting
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
Similarly an increase in hyperglycemic episodes was also noted in another study conducted by the Benghazi Diabetes and Endocrine Centre BDEC on 493 T2DM patients fasting during Ramadan where 107 experienced hyperglycemia Therefore appropriate treatment adjustments including insulin regimen are necessary to avoid both hypo and hyperglycemia during Ramadan fasting
T2DM patients well-controlled on premixed insulin or multiple doses injections should not fast and they have the legitimate exemption for this However many Muslim patients insist on fasting inspite of medical warning So the investigators aim in the current study to assess safety and efficacy of our hybrid method using of low-ratio premixed insulin take at Iftar and short acting insulin take at Suhoor compare to last recommendation of IDF guideline of using low-ratio premix insulin regimens in type 2 diabetic patients who insist on Ramadan fasting
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