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.: PACTR202310555394577 Date of Approval: 13/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Quality of Life in Children with Carotid Intima-Medial Thickness after Juvenile diabetes
Official scientific title Quality of Life in Children with Carotid Intima-Medial Thickness after Juvenile diabetes
Brief summary describing the background and objectives of the trial Intimo-medial thickness (IMT) is a measure of the combined thickness of intima and media layers of carotid artery, most commonly assessed by B-mode ultrasound. Increase in carotid intima–media thickness (CIMT) may result from hypertrophy of intimal or medial layers or both because cellular/molecular mechanisms that increase CIMT are also the factors responsible for development and progression of atherosclerosis. The purpose of this study was to investigate the impact of carotid intima- medial thickness on quality of life of children after juvenile diabetes.
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Circulatory System,Haematological Disorders,Nutritional, Metabolic, Endocrine,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 16/02/2023
Actual trial start date 30/04/2023
Anticipated date of last follow up 10/05/2023
Actual Last follow-up date 31/05/2023
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Duration of diabetes Hemoglobin A1C lipid profile carotid intima medial thickness Quality of life qu measured one time only 2 months till measurements finished Duration of diabetes Hemoglobin A1C lipid profile carotid intima medial thickness Quality of life questionnaire 50 Historical
Control Group Carotid intima thickness one time one month carotid intima thickness measured by laboratory investigations 50 Historical
Experimental Group heamoglobin A1C one time one month lab investigation for haemoglobin 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Age ranged from 5 to 13 years. • Height not less than one meter. • Their BMI is within normal range. • Children are normally developed physically with no alterations in posture or bone alignment proper joint function and efficient movement. • Children will not follow instructions. • Children with any cardiopulmonary problems. • Attitude and psychiatric disorders, length discrepancy; and seizures. • Children with neurological problems. Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 5 Year(s) 13 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 12/02/2023 Faculty of Physical Therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
El Zayat Giza 0002 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Carotid intima medial thickness one month
Secondary Outcome Quality of life Questionnaire one month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El Menia University out patient clinic El Menia University street El Menia 0002 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ass.Prof. Radwa Saeid Abdulrahman El Zayat Giza 0002 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical Therapy Cairo University El zayat Giza 0002 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Assist. Prof. Dr. Mostafa Soliman Mostafa Ali El zayat Giza 0002 Egypt
Prof.Dr.Reem Abdelsalam Abdelaziz El zayat Giza 0002 Egypt
Dr. Nour El Bakry El Zayat Giza 0002 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Radwa Mahmoud radwakku@gmail.com 00201027713662 El Zayat
City Postal code Country Position/Affiliation
Giza 0002 Egypt Assistant Professor
Role Name Email Phone Street address
Public Enquiries Mostafa Ali drmostafamalak@cu.edu.eg 00201027713662 El zayat
City Postal code Country Position/Affiliation
Giza 0002 Egypt Assistant Professor
Role Name Email Phone Street address
Scientific Enquiries Reem Abdulsalam Reemabdelsalam3@gmail.com 00201027713662 El Zayat
City Postal code Country Position/Affiliation
Giza 0002 Egypt Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes I Here by we the authors of this work are obligated to share data and obtained results soon as this work is finished Study Protocol the study will be available within 2 years and data will be given by a clear URL mentioned in the URL section below after publication the results of this study will be given by a third party that was not involved in the study
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