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.: PACTR201910650895114 Date of Approval: 21/10/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Predictive value of glycated albumin (GA%) versus glycosylated hemoglobin (HbA1c%) in follow up of glucose homeostasis in hemodialysis-maintained type -2 diabetic patients
Official scientific title Predictive value of glycated albumin (GA%) versus glycosylated hemoglobin (HbA1c%) in follow up of glucose homeostasis in hemodialysis-maintained type -2 diabetic patients
Brief summary describing the background and objectives of the trial The best glycemic marker for glucose control in hemodialysis patients is still debated. HbA1c% measurement relies on a relatively stable RBC survival, which is the case in patients on HD. The metabolic turnover of albumin is faster than haemoglobin. So, GA% may be used as an index of short-term glycaemic control. Aim of the work: Find out the predictive value of GA% versus HbA1c% in monitoring of glucose homeostasis in type-2 diabetic patients maintained on hemodialysis.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/01/2018
Actual trial start date
Anticipated date of last follow up 01/01/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group abdominal ultrasound once 15 minutes Through the abdominal wall, organs inside the pelvis can be seen, such as the urinary bladder or the ovaries and uterus in women. Because water is an excellent conductor for ultrasound waves, visualizing these structures often requires a well-filled urinary bladder 20 Uncontrolled
Experimental Group haemodialsis 3times/ week 6 months patient's blood is drawn out through a tube at a rate of 200–400 mL/min. The tube is connected to a 15, 16, or 17 gauge needle inserted in the dialysis fistula or graft, or connected to one port of a dialysis catheter. The blood is then pumped through the dialyzer, and then the processed blood is pumped back into the patient's bloodstream through another tube 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
type-2 diabetic patients maintained on regular hemodialysis recently (less than one-year duration) Type-1 DM; Conditions that affect blood homeostasis such as acute and chronic blood loss, recent blood transfusion, hemolytic anemia, splenomegaly, haemoglobinopathies, Liver cirrhosis, HIV positivity patients and Alcohol abuse subjects Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 75 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 01/01/2018 FacultyofMedicineResearch Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Minia University Minia 61111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Diagnostic accuracy of HbA1c is higher than GA. 6 months
Secondary Outcome HOMA-IR is superior for both as regard sensitivity (100%) and diagnostic accuracy (85%) in such issue. 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Minia University Hemodialysis unit Minia University Minia 61111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Minia University Minia University Minia 61111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Elham Ahmed Minia University Minia 61111 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Elham Ahmed Minia University Minia 61111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Elham Ahmed elhamo2011@gmail.com +20862156056 Minia University
City Postal code Country Position/Affiliation
Minia 61111 Egypt Assisstant Profeesor
Role Name Email Phone Street address
Public Enquiries Elham Ahmed elhamo2011@gmail.com +20862156056 Minia University
City Postal code Country Position/Affiliation
Minia 61111 Egypt Assisstant Profeesor
Role Name Email Phone Street address
Scientific Enquiries Elham Ahmed elhamo2011@gmail.com +20862156056 Minia University
City Postal code Country Position/Affiliation
Minia 61111 Egypt Assisstant Profeesor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes demographic ,clinical and laboratory Study Protocol 2 years controlled
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