Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201907856711564 Date of Approval: 04/07/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Effect of Lisinopril and Verapamil on Circulating Angiopoietin 2 and Endostatin in Hypertensive Diabetic Patients with Nephropathy
Official scientific title The Effect of Lisinopril and Verapamil on Circulating Angiopoietin 2 and Endostatin in Hypertensive Diabetic Patients with Nephropathy
Brief summary describing the background and objectives of the trial Angiogenesis is a multistep process implicated in the pathophysiology and progression of diabetic nephropathy (DN). The use of angiotensin-converting enzyme inhibitors (ACEI) and calcium channel blockers (CCB) have an important role in DN. We performed a randomized-controlled trial of Lisinopril alone (an ACEI) or in combination with verapamil (a CCB) as a therapy for DN in type 2 diabetes mellitus (T2DM) patients with hypertension (HTN) and urinary albumin creatinine ratio (UACR) (30-300 mg/g) and evaluate their effect on UACR, the angiogenic proteins; Angiopoietin 2 (Ang-2); and Endostatin (EST).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Kidney Disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/12/2018
Actual trial start date 01/01/2019
Anticipated date of last follow up 30/03/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 40
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
2402018 research ethics committee faculty of pharmacy ain shams university
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group lisinopril 5 mg 3 months T2DM with HTN and (UACR) (30-300 mg/g) who received oral lisinopril tablets once daily 20 Active-Treatment of Control Group
Experimental Group verapamil plus lisinopril 120 mg and 5 mg 3 months T2DM with HTN and (UACR) (30-300 mg/g) who received oral verapamil and lisinopril tablets once daily 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
T2DM patients aged between 45 and 65 years. 5 years’ disease duration. Active DN in the form of microalbuminuria (UACR: 30-300 mg/g) in two of three samples over a 3 months’ period prior to study. Hemoglobin A1C (HbA1c) ≤8.5%. Active urinary tract infection. End Stage Renal disease. End Stage Liver disease. Cancer. Hematological disorders. Patients taking immunosuppressive medicine. a recent history of acute myocardial infarction, stroke, or occlusive. Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/10/2018 research ethics comittee ain shams university
Ethics Committee Address
Street address City Postal code Country
African union organization beside the Ain Shams University specialized hospital in Abbaseya cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome urinary albumin creatinine ratio,endostatin and angiopoitien 2 kidney damage biomarkers at study start and after 3 months
Secondary Outcome fasting blood glucose, glycated hemoglobin and lipid profile at study start and after 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ain shams university hospital African union organization beside the Ain Shams University specialized hospital in Abbaseya. cairo 11566 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohammed Salem 4th district - 6th of october giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of pharmacy ain shams university African union organization street CAIRO Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Dr. AlAliaa Sallam hadayk elquba cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammed Salem drmsalem25@gmail.com 00201022525677 4th district six of october city
City Postal code Country Position/Affiliation
giza Egypt faculty of pharmacy ahram canadian university
Role Name Email Phone Street address
Scientific Enquiries AlAliaa Sallam alia.sallam@pharma.asu.edu.eg 00201060791541 hadayk elquba
City Postal code Country Position/Affiliation
cairo Egypt faculty of pharmacy ain shams univeristy
Role Name Email Phone Street address
Public Enquiries Hala Elmosalamy hala_elmosalamy@hotmail.com 00201061669913 nasr city
City Postal code Country Position/Affiliation
cairo Egypt faculty of pharmacy ain shams univeristy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes ALL enrolled patients assessed for hypertension , diabetes mellitus, lipid profile& kidney function before & at the study end. all laboratory data are listed in a collective sheet to be analyzed at the study end. Informed Consent Form maximum 12 months at the study end open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information