Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
70 participants
INTERVENTIONAL
2024-01-01
2025-12-31
Brief Summary
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Detailed Description
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Despite the significant decline in diabetes-related complications in recent decades, the same trend cannot be observed in chronic kidney disease (CKD) patients due to DKD that requires KRT. Hence, there exists a significant requirement for novel treatment approaches that can enhance glycemic control while minimizing the risk of hypoglycemia, as well as reducing cardiovascular and renal risks within this population. Irrespective of the limitations associated with estimated glomerular filtration rate (eGFR), it is crucial to develop new treatments that can effectively address these concerns.
ACE inhibitors may delay the progression of nephropathy and reduce the risks of cardiovascular events in hypertensive patients with diabetes mellitus type I and type II.
SGLT2i have become the new standard of care for slowing CKD progression in patients with type 2 diabetes mellitus (T2DM, due to their specific renal and cardiovascular protective effects that are independent of the main metabolic and glucose-lowering effects.
Research questions:
Q1. Is there a significant effect of ACEi in treatment of patients with diabetic kidney disease.
Q2: Is there is a significant effect of SGLT2i in treatment of patients with diabetic kidney disease.
Q3: Which is more significantly efficient in treatment of patients with diabetic kidney disease (ACEi versus SGLT2i)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Efficacy of ACEi
Patients receive an ACEi medication, such as lisinopril, enalapril, or ramipril. These drugs work by blocking the production of angiotensin II, a hormone that can constrict blood vessels and raise blood pressure.
lisinopril, enalapril
1. Both arms should aim to achieve optimal blood pressure control, typically defined as a systolic blood pressure below 130 mmHg and a diastolic blood pressure below 80 mmHg. This can be achieved through lifestyle modifications, additional medications, or a combination of both.
2. Maintaining good glycemic control is also important for both arms. This can be achieved through diet, exercise, and diabetes medications.
3. Both arms may also receive other supportive care measures for DKD, such as protein restriction, dietary counseling, and management of other co-morbidities like anemia and hyperlipidemia.
Efficacy of SGLT2i
Patients receive an SGLT2i medication, such as dapagliflozin, empagliflozin, or canagliflozin. These drugs work by preventing the kidneys from reabsorbing glucose from the urine, leading to lower blood sugar levels and potentially reducing the risk of kidney damage.
dapagliflozin, empagliflozin
1. Both arms should aim to achieve optimal blood pressure control, typically defined as a systolic blood pressure below 130 mmHg and a diastolic blood pressure below 80 mmHg. This can be achieved through lifestyle modifications, additional medications, or a combination of both.
2. Maintaining good glycemic control is also important for both arms. This can be achieved through diet, exercise, and diabetes medications.
3. Both arms may also receive other supportive care measures for DKD, such as protein restriction, dietary counseling, and management of other co-morbidities like anemia and hyperlipidemia.
Interventions
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lisinopril, enalapril
1. Both arms should aim to achieve optimal blood pressure control, typically defined as a systolic blood pressure below 130 mmHg and a diastolic blood pressure below 80 mmHg. This can be achieved through lifestyle modifications, additional medications, or a combination of both.
2. Maintaining good glycemic control is also important for both arms. This can be achieved through diet, exercise, and diabetes medications.
3. Both arms may also receive other supportive care measures for DKD, such as protein restriction, dietary counseling, and management of other co-morbidities like anemia and hyperlipidemia.
dapagliflozin, empagliflozin
1. Both arms should aim to achieve optimal blood pressure control, typically defined as a systolic blood pressure below 130 mmHg and a diastolic blood pressure below 80 mmHg. This can be achieved through lifestyle modifications, additional medications, or a combination of both.
2. Maintaining good glycemic control is also important for both arms. This can be achieved through diet, exercise, and diabetes medications.
3. Both arms may also receive other supportive care measures for DKD, such as protein restriction, dietary counseling, and management of other co-morbidities like anemia and hyperlipidemia.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Urosepsis and Pyelonephritis
* Lower limb amputation
* diabetic Ketoacidosis
* Euglycemic DKA
* Acute Kidney Injury
* Hypoglycemia
* Fournier Gangrene
* Hypersensitivity Reactions
* Bone fracture
* Bladder cancer
* Hyperkalemia
* Dyslipidemia
18 Years
75 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Ismael ahmed amin mohammed alaraby
Director of the Health Affairs Directorate
Principal Investigators
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Mohammed El-Tohamy, prof
Role: STUDY_DIRECTOR
Assiut University
Walaa khalifa, prof
Role: STUDY_DIRECTOR
Assiut University
Central Contacts
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Other Identifiers
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diabetic kidney
Identifier Type: -
Identifier Source: org_study_id
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