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

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).

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes; SGLT2 Inhibitors, First Time Use; Fasting in Ramadan
• Intervention / Treatment: Diagnostic test: HbA1c, serum creatinine, eGFR urine analysis and serum electrolyte Na and K

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood glucose level monitoring	measurement of HbA1c in percent	6 weeks after ramadan
safety of SGLT2 inhibitors usage during ramadan	measurement of serum creatinine mg/dl	6 weeks after ramadan

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2023
• Primary Completion (Actual): June 25, 2023
• Study Completion (Actual): September 25, 2023

Study Registration Dates

• First Submitted: November 7, 2023
• First Submitted That Met QC Criteria: April 13, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 13, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: SGLT2 inhibitors; type 2 DM; fasting inramadan
• Other Study ID Numbers: Soh-Med-23-04-07PD.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No