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.: PACTR201801002776119 Date of Approval: 16/11/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Cytokines and T2D in Egyptian diabetic patients
Official scientific title Association between cytokines production and T2D glycemic control in Egyptian patients
Brief summary describing the background and objectives of the trial Several investigations reported that 45.7% of diabetics were obese, and 78.5% were overweight. In addition, it has been shown that waist circumference and body max index (BMI) - as the obesity markers - are the major risk factor of developing diabetes T2. Cytokines play a very important role in nearly all aspects of inflammation and immunity. Interleukins are a type of cytokines that were first seen to be expressed by leukocytes. Cytokines have been shown to promote hepatic fatty acid syntheses and induce the liver to produce more acute-phase proteins, as well as recruit more inflammatory cells to adipose tissue and pancreatic beta-cells. Moreover, TNF-¿ is known to directly inhibit insulin signaling, resulting in insulin resistance. Therefore, inflammatory cytokines not only affect insulin resistance but may also contribute directly to beta-cell apoptosis and beta-cell failure, ultimately leading to type 2 diabetes.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) Observational
Disease(s) or condition(s) being studied Diabetes T2,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial cytokines production and T2D glycemic
Anticipated trial start date 16/11/2017
Actual trial start date 01/12/2017
Anticipated date of last follow up 15/01/2018
Actual Last follow-up date 15/02/2018
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 95
Recruitment status Not yet recruiting
Publication URL diabetology journals
Secondary Ids Issuing authority/Trial register
111/017/2018 1510/017/2018
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 Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group groups of diabetic treatments like, metformin according to the manufacturer provided 2 monthes Group2 20
Experimental Group groups of diabetic treatments like,sulphonylureas, according to the manufacturer provided 2 monthes Group3 20
Control Group groups of diabetic non 2 monthes Group1 30 Active-Treatment of Control Group
Experimental Group groups of diabetic treatments ,insulin according to the manufacturer provided 2 monthes Group 4 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
50 T2D-free controls and 100 patients diagnosed with type 2 diabetes and on any of the oral hypoglycemic agents will be recruited.T2D-free controls enrolled in the study had no type I or II diabetes. Patients with infectious diseases, autoimmune disorders, asthma, eczema, allergies, thyroid diseases, kidney failure, liver dysfunction and alcohol abuse will be excluded from the study. In addition, patients who underwent medication changes during the 2 months preceding participation will be also excluded from the study 18 Year(s) 70 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
No 03/10/2017 Beni-Suef University ethics committee
Ethics Committee Address
Street address City Postal code Country
salah salem Beni Suef 62511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The association between IL-17,IL-18, IL-23,IL-10,IL-37 and IL-35 production and glycemic control of T2D in Egyptian patients were elucidated. 15/1/2018
Secondary Outcome the association between diabetic clinical complications of T2D and inflammatory cytokines were observed 1/2/2018
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Altamin hospital Abdel salam aref Beni-Suef 62512 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
none none Beni-Suef 62512 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor none University
COLLABORATORS
Name Street address City Postal code Country
Altameen Alsehi Abdsalam Aref Beni-Suef 62512 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Wessam Al daleel wessamaddaleel@gmail.com +211103360317 Salah salem
City Postal code Country Position/Affiliation
Beni Suef 62511 Egypt Faculty of Science, Beni-Suef University
Role Name Email Phone Street address
Principal Investigator Eman Salah em4salah@yahoo.com +212005664329 Ahmad Orapy st
City Postal code Country Position/Affiliation
Beni Suef 62511 Egypt Faculty of Science, Beni-Suef University
Role Name Email Phone Street address
Public Enquiries Mohamed Zanaty zanaty012@yahoo.com +211103360317 Salah salem
City Postal code Country Position/Affiliation
Beni Suef 62511 Egypt Biotechnology Department, Postgraduate Studies for Advanced Science, Beni-Suef University, Egypt
Role Name Email Phone Street address
Scientific Enquiries Eman Ezz aldein eman_ezzeldien@yahoo.com +201204506371 25 Abasery st
City Postal code Country Position/Affiliation
Beni-Suef 62511 Egypt Physiology division, Faculty of Science, Beni-Suef University, Egypt.
REPORTING
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