Clinical trial NCT06528002: Hybrid Method Between Low-ratio Premixed Insulin and Short Acting Insulin in Fasting Type 2 Diabetic Patients in Ramadan
Official title: Hybrid Method Between Low-ratio Premixed Insulin and Short Acting Insulin in Fasting Type 2 Diabetic Patients in Ramadan: Safety and Efficacy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Continous Blood Glucose Monitoring
Calculation of Body Mass Index
Measurment of Blood Pressure
Keywords: type 2 DM.fasting in ramadan .insulin therapy
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will carry out on Muslim type 2 DM patients willing to fast Ramadan during the year 2024 attending outpatient clinic, Sohag faculty of medicine, Sohag university, Egypt.

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.

Eligibility criteria: 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

Primary outcomes:
measure: effect of hyprid method of insulin in type 2 diabetic patients during fasting in ramadan
timeFrame: 4 weeks after ramadan
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag Faculty of Medicine
Study officials:
affiliation: sohag university .faculty of medicine
name: Sara Kasem Abdelal, lecturer
role: STUDY_CHAIR
affiliation: sohag university .faculty of medicine
name: Ahmed Faysal El_Rawy, lecturer
role: STUDY_CHAIR
affiliation: sohag university .faculty of medicine
name: Marwa zanaty Elsayed, lecturer
role: STUDY_CHAIR
References: