- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07302464
Sodium Glucose Co-Transporter 2 Inhibitors on Estimated Glomerular Filtration Rate in Diabetic Versus Non-Diabetic Chronic Kidney Disease Patients
Effect of Sodium Glucose Co-Transporter 2 Inhibitors on Estimated Glomerular Filtration Rate in Diabetic Versus Non-Diabetic Chronic Kidney Disease Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Glucose reabsorption is mediated by the sodium-glucose cotransporter (SGLT) 2, which reabsorbs 90% of glucose, and SGLT1, which reabsorbs the remaining 10%.
The relationship between hyperglycaemia and the development of renal disease is complex. Hyperglycaemia-induced complications are mediated by several metabolic pathways, among which accumulation of Advanced Glycation End-products with abnormalities of the glycosylation of macromolecules and increased glucose flux through the polyol pathway seem to be the most important.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt, 11591
- Ain Shams University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 18 years.
- Both sexes.
- Chronic kidney disease (CKD) participants with stages 3 and 4.
Exclusion Criteria:
- Patients with type 1 diabetes mellitus (DM).
- Patients with decompensated Chronic liver disease.
- Patients with uncontrolled hypertension.
- Patients with blood pressure (BP) > 110/70.
- Patients already on the same medication (Sodium Glucose Co-Transporter 2 Inhibitors).
- Patients with a history of recurrent or recent urinary tract infection (UTI).
- Patients with glycated hemoglobin (HbA1c) ≤10.
- Adult polycystic kidney disease.
- All patients on immunosuppressive medications.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Study group
Chronic kidney disease (CKD) participants with type 2 diabetes mellitus (T2DM)
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All candidates start therapy with sodium glucose co-transporter 2 (SGLT2) inhibitors with a dose of 10mg daily Dapagliflozin for 6 months
|
|
Control group
Chronic kidney disease (CKD) participants without diabetes mellitus
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All candidates start therapy with sodium glucose co-transporter 2 (SGLT2) inhibitors with a dose of 10mg daily Dapagliflozin for 6 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the estimated glomerular filtration rate
Time Frame: 6 months post-procedure
|
Change in the estimated glomerular filtration rate (eGFR) was recorded.
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6 months post-procedure
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Endocrine System Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Metabolic Diseases
- Glucose Metabolism Disorders
- Renal Insufficiency
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Diabetes Mellitus
- Renal Insufficiency, Chronic
Other Study ID Numbers
- FMASU MS 603/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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