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).

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Key information

Conditions

SGLT2 Inhibitors, First Time Use Fasting in Ramadan Type2 Diabetes

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sohag Faculty of Medicine

Sohag, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Diagnostic Test

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

Primary outcomes

blood glucose level monitoring

Time frame: 6 weeks after ramadan

measurement of HbA1c in percent
safety of SGLT2 inhibitors usage during ramadan

Time frame: 6 weeks after ramadan

measurement of serum creatinine mg/dl

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Apr 17, 2024
Registry last updated: Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed