Nephroprotective Effect of Nicorandil in Type 2 Diabetes Mellitus
NCT ID: NCT06430125
Last Updated: 2024-05-28
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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RECRUITING
PHASE3
46 participants
INTERVENTIONAL
2023-02-28
2025-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Control group
this group will include 23 patients who will receive metformin 2gm/day. The initial dose of metformin will be 1 g/day taken orally with the meal. After 7 days (week 1), the dose will be up titrated to daily dose of 2,000 mg/day. Treatment duration will be 12 weeks .
No interventions assigned to this group
Nicorandil group
this group will include 23 patients who will receive a combination of metformin 2g/day and nicorandil 10 mg twice daily. The initial dose of metformin will be 1 g/day taken orally with the meal. After 7 days (week 1), the dose will be uptitrated to daily dose of 2,000 mg/day. Treatment duration will be 12 weeks .
Nicorandil 10 MG Oral Tablet
Nicorandil 10 MG oral tablet twice daily
Interventions
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Nicorandil 10 MG Oral Tablet
Nicorandil 10 MG oral tablet twice daily
Eligibility Criteria
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Inclusion Criteria
* Age range between 18 and 60 years old.
* Both sexes.
* Stage 1and Stage 2 CKD according to KDIGO .
* Controlled HTN .
Exclusion Criteria
* Patients with hypersensitivity to nicorandil.
* Other Causes of CKD or Nephropathy eg : Uncontrolled HTN , Renal Malignancy , collagen disease as Amyloidosis and some autoimmune disease as ( SLE and Rh.fever ) .
* Uncontrolled HTN and its antihypertensive medications ( ACEI , ARB ) and other antihypertensive medications .
* Patients receiving nephrotoxic drugs as aminoglycosides, non-steroidal anti inflammatory drugs and contrast media.
18 Years
60 Years
ALL
No
Sponsors
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Tanta University
OTHER
Responsible Party
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Mohammed Atta Ali El-Hazzab
Principal Investigator
Locations
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Tanta University
Tanta, EL Gharbia, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Nicorandil Nephroprotective
Identifier Type: -
Identifier Source: org_study_id
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