First-time Usage of SGLT2 Inhibitors in Type 2 Diabetic Patients Who Are Fasting During Ramadan: Safety and Efficacy

NCT ID: NCT06370247

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-25
• Study Completion Date: 2023-09-25

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 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 Ramadan.According 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 Ramadan.Several 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).

Conditions

SGLT2 Inhibitors, First Time Use; Type2 Diabetes; Fasting in Ramadan

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

patients With T2DM, willing to fast Ramadan and treated with SGLT2 inhibitors

Egyptian male and female Muslim patients, aged ≥ 18 years old. With T2DM, willing to fast Ramadan and treated with SGLT2 inhibitors (empagliflozin, dapagliflozin) as an add-on to metformin or other oral hypoglycemic agent.

Group Type: OTHER

HbA1c, serum creatinine, eGFR urine analysis and serum electrolyte Na and K

Intervention Type: DIAGNOSTIC_TEST

HbA1c, serum creatinine, eGFR urine analysis and serum electrolyte Na and K will measure

Interventions

HbA1c, serum creatinine, eGFR urine analysis and serum electrolyte Na and K

HbA1c, serum creatinine, eGFR urine analysis and serum electrolyte Na and K will measure

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Egyptian male and female Muslim patients,
• aged ≥ 18 years old.
• patients with T2DM
• willing to fast Ramadan and treated with SGLT2 inhibitors (empagliflozin, dapagliflozin) as an add-on to metformin or other oral hypoglycemic agent.

Exclusion Criteria

• *Patients with chronic liver disease (serum levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase above 2 times upper limit of normal value).

• Patients with chronic renal disease (estimated glomerular filtration rate (eGFR) <25 ml/min/1.73 m2).
• Patients on renal dialysis
• patients with a history of ketoacidosis in the past six months patients had a history of malignancy during the past three years.
• Also, subjects with strokes including transient ischemic attack (TIA),
• patients with diabetic foot infection, amputation (non-traumatic even minor), or gangrene were excluded.
• In addition to pregnant or breast-feeding women.
• Besides, those who had a history of frequent urinary tract infections (UTI) were also excluded from the study.

Patients who will discontinue the SGLT2i during Ramadan and those who will fast for less than 15 days will be excluded from the final analysis.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Hany Ahmed Mohamed

lecturer of internal medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag Faculty of Medicine

Sohag, , Egypt

Countries

Egypt

References

Khalil HAM, Abdelal SK, El-Rawy AF, Abodahab ALH. First-Time Usage of SGLT2 Inhibitors in Patients With Type 2 Diabetes Who Are Fasting Ramadan: Efficacy and Safety. J Diabetes Res. 2025 Apr 25;2025:4321423. doi: 10.1155/jdr/4321423. eCollection 2025.

Reference Type: DERIVED

PMID: 40322737 (View on PubMed)

Other Identifiers

Soh-Med-23-04-07PD.

Identifier Type: -

Identifier Source: org_study_id