Hybrid Method Between Low-ratio Premixed Insulin and Short Acting Insulin in Fasting Type 2 Diabetic Patients in Ramadan

Completed

• Conditions: Continous Blood Glucose Monitoring; Measurment of Blood Pressure; Calculation of Body Mass Index

• Registration Number: NCT06528002
• Lead Sponsor: Sohag University

Brief Summary

All healthy Muslim adults are required to observe the Ramadan fast, which is one of Islam's five pillars. People with Type 2 Diabetes Mellitus(T2DM). 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 Islam's five pillars. People with Type 2 Diabetes Mellitus(T2DM). 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 10.7% 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 Timeline

• Study Start: 2024-03-01
• Primary Completion: 2024-05-15
• Study Completion: 2024-06-15
• Status Verified: 2024-07
• Study First Submitted: 2024-07-15
• Study First Submitted QC: 2024-07-29
• Study First Posted: 2024-07-30
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Egyptian male and female Muslim patients,With T2DM, willing to fast Ramadan

  • . age ≥ 18 years old.
  • . type 2 diabetic patients treated with premixed insulin alone or combined with oral antidiabetic drugs (metformin, sulfonylurea: gliclazide, dipeptidyl peptidase 4 Inhibitor: sitagliptin or vildagliptin or thiazolidinediones/glitazones).

Exclusion Criteria

• type 1 diabetic patients
• uncontrolled type 2 diabetics (HbA1c > 9; but they were included if insisting on fasting despite the detailed medical advice very high-risk diabetics (according to IDF 2021 classification)9
• newly diagnosed as diabetics (< 3 months)
• patients with previous ketoacidosis or hyperosmolar hyperglycemic states, recurrent or severe hypoglycemia within the past 2 months
• type 2 diabetic patients with hypoglycemic unawareness.
• Hospitalized patients, besides pregnant and lactating females

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
effect of hyprid method of insulin in type 2 diabetic patients during fasting in ramadan	4 weeks after ramadan	This is a study aiming to assess the safety and efficacy of our hybrid method compare to last recommendation of IDF guideline of using low-ratio premix insulin regimens in type 2 diabetic patients who insist on Ramadan fasting. and this done by measurement of blood glucose level 7 times daily to detect control of blood glucose during fasting in ramadan .then will measure fasting and postprandial blood glucose level after ramadan

Trial Locations

Locations (1)

Sohag Faculty of Medicine; 🇪🇬 Sohag, Egypt