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.: PACTR201803003178234 Date of Approval: 09/03/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Toxoplasma gondii as a possible causative pathogen of type-1 diabetes mellitus: Evidence from case-control and experimental studies
Official scientific title Toxoplasma gondii as a possible causative pathogen of type-1 diabetes mellitus: Evidence from case-control and experimental studies
Brief summary describing the background and objectives of the trial Toxoplasma gondii is the causative parasite of an important worldwide disease. This obligate intracellular parasite can infect and replicate inside any nucleated cells including those of pancreas. Insulin is a hormone secreted by the pancreas and is responsible for controlling blood glucose concentration. Deficiency of insulin production accounts for the occurrence of type-1 diabetes mellitus (T1D). Thus, theoretically, toxoplasmosis could play a possible role in the development of T1D. However, the studies on this theory are still insufficient; therefore, this work was designed. This study included three groups; a group of type-1 diabetic patients, a group of type-2 diabetic patients and a control group of healthy individuals. All groups were tested for serum glucose level and measurement of serum anti- Toxoplasma IgG to determine if there is an association between the seropositivity of toxoplasmosis and diabetes. Additionally, an experimental animal study was done to investigate the same relationship between toxoplasmosis and development of diabetes. In the experimental study three mice groups were included; a control group, an acutely infected mice with T. gondii, and a chronic infection group. All mice groups were subjected to measurement of serum glucose concentrations. After sacrifaction of mice, the pancreatic tissues were fixed in 10% formalin and processed in blocks and stained with haematoxylin and eosin and immunohistochemical markers (CD4, CD68, Caspase-3 and Ki96) to study if toxoplasmosis is able to induce insulitis " a prediabetic state" in pancreas of infected animals.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied the relation between toxoplasmosis and diabetes
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/06/2016
Actual trial start date 05/06/2016
Anticipated date of last follow up 01/01/2017
Actual Last follow-up date 01/01/2017
Anticipated target sample size (number of participants) 104
Actual target sample size (number of participants) 104
Recruitment status Stopped early/ terminated
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
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
Control Group group III ONCE Measurement of anti-Toxoplasma IgG 30 Placebo
Experimental Group group I ONCE Measurement of anti-Toxoplasma IgG 44
Experimental Group GROUP II ONCE Measurement of anti-Toxoplasma IgG 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with symptoms of diabetes (thirst, polydipsia, polyuria, weight loss) were diagnosed as having diabetes once fasting plasma glucose level of ¿ 126 mg/dL (¿ 7.0 mmol/L); and/or 2-h value in 75 g oral glucose tolerance test (OGTT) of ¿ 200 mg/dL (¿ 11.1 mmol/L); and/or random plasma glucose level of ¿ 200 mg/dL Age below 10 years BMI > 30 10 Year(s) 60 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 03/01/2016 Menuofia Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
3 Yassin Abdel Gaffar St. Shebin El-Kom 02048 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Serum level of anti-Toxoplasma IgG at morning
Secondary Outcome serum glucose level at morning
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University Hospital 3 Yassin Abdel Gaffar St. Shebin Elkom 02048 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Menoufia Faculty of Medicine 3 Yassin Abdel Gaffar St. Shebin Elkom 02048 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Menoufia Faculty of Medicine 3 Yassin Abdel Gaffar St. Shebin Elkom 02048 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Engy Victor Nassief Beshay 3 Yassin Abdel Gaffar St. Shebin Elkom 02048 Egypt
Samar A. El-Refai 3 Yassin Abdel Gaffar St. Shebin Elkom 02048 Egypt
Mohamed A. Helwa 3 Yassin Abdel Gaffar St. Shebin Elkom 02048 Egypt
Amany Fawzy Atia 3 Yassin Abdel Gaffar St. Shebin Elkom 02048 Egypt
Marwa Mohammed Dawoud 3 Yassin Abdel Gaffar St. Shebin Elkom 02048 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Engy Beshay engy.victor77@yahoo.com 01201421955 3 Yassin Abdel Gaffar St.
City Postal code Country Position/Affiliation
Shebin Elkom 02048 Egypt Lecturer of Parasitology, Menoufia Faculty of Medicine
Role Name Email Phone Street address
Public Enquiries Samar El-Refai mmdah1976@gmail.com 01090229696 3 Yassin Abdel Gaffar St.
City Postal code Country Position/Affiliation
Shebin Elkom 02048 Egypt Lecturer of Parasitology, Menoufia Faculty of Medicine
Role Name Email Phone Street address
Scientific Enquiries Amany Atia amanyatia80@yahoo.com 01023020134 3 Yassin Abdel Gaffar St.
City Postal code Country Position/Affiliation
Shebin Elkom 02048 Egypt Lecturer of Parasitology, Menoufia Faculty of Medicine
REPORTING
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