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

NCT06370247 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-04-17

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Sohag University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-25
Primary Completion
2023-06-25
Completion
2023-09-25

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06370247 on ClinicalTrials.gov