SGLT2 Inhibitors, First Time UseNCT06370247
First-time Usage of SGLT2 Inhibitors in Type 2 Diabetic Patients Who Are Fasting During Ramadan: Safety and Efficacy
A study testing HbA1c, serum creatinine, eGFR urine analysis and serum electrolyte Na and K in people with SGLT2 Inhibitors, First Time Use and Type2 Diabetes, run by Sohag University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- SGLT2 Inhibitors, First Time Use, Type2 Diabetes, Fasting in Ramadan
- What is being tested?
- HbA1c, serum creatinine, eGFR urine analysis and serum electrolyte Na and K
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Apr 2023to 25 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- *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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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).
- Being tested
- HbA1c, serum creatinine, eGFR urine analysis and serum electrolyte Na and K
- Keywords
- SGLT2 inhibitors, type 2 DM, fasting inramadan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HbA1c, serum creatinine, eGFR urine analysis and serum electrolyte Na and KDiagnostic test
HbA1c, serum creatinine, eGFR urine analysis and serum electrolyte Na and K will measure
| Study group | Role | What they receive |
|---|---|---|
| patients With T2DM, willing to fast Ramadan and treated with SGLT2 inhibitors | Other | 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. Receives: Diagnostic Test: HbA1c, serum creatinine, eGFR urine analysis and serum electrolyte Na and K |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood glucose level monitoring
measurement of HbA1c in percent
Measured: 6 weeks after ramadan
safety of SGLT2 inhibitors usage during ramadan
measurement of serum creatinine mg/dl
Measured: 6 weeks after ramadan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start25 Apr 2023
- Primary completion25 Jun 2023
- Study completion25 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SGLT2 Inhibitors, First Time UseStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Ahmed Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370247
- Sponsor's protocol ID
- Soh-Med-23-04-07PD.
- Status last verified
- Apr 2024
- First submitted
- 7 Nov 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40322737
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-time Usage of SGLT2 Inhibitors in Type 2 Diabetic Patients Who Are Fasting During Ramadan: Safety and Efficacy
- ClinicalTrials.gov ID
- NCT06370247
- Acronym / sponsor ID
- Soh-Med-23-04-07PD.
- Keywords
- SGLT2 inhibitors, type 2 DM, fasting inramadan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 25 Jun 2023 (actual)
- Study completion
- 25 Sep 2023 (actual)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients With T2DM, willing to fast Ramadan and treated with SGLT2 inhibitors | Other | Diagnostic Test: HbA1c, serum creatinine, eGFR urine analysis and serum electrolyte Na and KEgyptian 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- *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 who will discontinue the SGLT2i during Ramadan and those who will fast for less than 15 days will be excluded from the final analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HbA1c, serum creatinine, eGFR urine analysis and serum electrolyte Na and KHbA1c, serum creatinine, eGFR urine analysis and serum electrolyte Na and K will measure | Diagnostic test | patients With T2DM, willing to fast Ramadan and treated with SGLT2 inhibitors |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Derived from this study: PubMed 40322737Khalil 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HbA1c, serum creatinine, eGFR urine analysis and serum electrolyte Na and K in people with SGLT2 Inhibitors, First Time Use and Type2 Diabetes, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood glucose level monitoring (time frame: 6 weeks after ramadan). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06370247, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.