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.: PACTR201712002777310 Date of Approval: 17/11/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Glycemic and Inflammatory status of Type2 Diabetes after Antiviral Therapy for HCV
Official scientific title Changes in Glycemic and Inflammatory status of Type2 Diabetes after Antiviral Therapy for HCV Genotype 4 Patients
Brief summary describing the background and objectives of the trial Infection with hepatitis C virus (HCV) is a major cause of chronic hepatitis, cirrhosis and hepatocellular carcinoma worldwide. Growing evidence shows that HCV increases the risk of incident type 2 diabetes mellitus (T2DM) in predisposed individuals. The mechanism whereby HCV induces T2DM is insulin resistance (IR). HCV was shown to impair the hepatocyte insulin signaling pathway by several mechanisms, including the stimulus to the production of tumour necrosis factor-¿, serine phosphorylation of the insulin receptors (IRS), the over-expression of the suppressor of cytokines (SOC-3) and the induction of SOC-7. The virus-induced metabolic derange-ments may interact with host-related genetic and environmental factors, aggravating insulin resistance and possibly leading to the development of T2DM. An imbalance in the adipocytokine profile and the presence of liver steatosis/steatohepatitis could contribute to this scenario. If HCV is directly involved in the development of IR and T2DM, it is reasonable to hypothesise that its clearance might result in a parallel decrease in the risk of T2DM incidence. Conversely, a successful eradication of HCV would improve clinical outcomes in patients with established T2DM.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) Observational
Disease(s) or condition(s) being studied Diabetes T2,Infections and Infestations,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied hepatitis C virus HCV
Purpose of the trial Treatment: Drugs
Anticipated trial start date 25/11/2017
Actual trial start date 04/12/2017
Anticipated date of last follow up 30/03/2018
Actual Last follow-up date 15/05/2018
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 95
Recruitment status Not yet recruiting
Publication URL Gasterenterology and diabetes journals
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 groups of treatments ,Sof/DCV/SMV/RBV according to the manufacturer provided 3 monthes Group1 30 Active-Treatment of Control Group
Experimental Group groups of treatments,Sof/DCV/SMV/RBV+ matformin according to the manufacturer provided 3 monthes Group2 30
Experimental Group groups of treatments ,Sof/DCV/SMV/RBV+ sulphonylurea + insulin according to the manufacturer provided 3 monthes Group3 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
100 Patients diagnosed with type 2 diabetes and HCV-GT4 and treated with two direct antiviral agents (DAAs) will be follow up at 1-baseline, 2-after treatment(12 wks) and 3-12 wks after the end of treatments Patients with other infectious diseases, autoimmune disorders, asthma, eczema, allergies, thyroid diseases, kidney failure, liver decompensation and alcohol abuse will be excluded from the study. 22 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
No 01/11/2017 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 glycemic status (F. glucose, HbA1c, F. insulin, HOMA-IR) was improved after after antiviral treatments 15/3/2018
Secondary Outcome changes in IL1,6,-17,23 and Gluc T2 gene polymorphism in diabetic patients treated with DAAs. 15-4-2018
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
General Hospital Kornish Beni-Suef 62511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
none
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
None
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Zanaty zanaty012@yahoo.com +212005564389 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
Public Enquiries Adel Men adel_men2020@yahoo.com +21005451764 Salah salem
City Postal code Country Position/Affiliation
Beni Suef 62511 Egypt Faculty of Science, Beni-Suef University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Abdel Gabbar hhmgabar@yahoo.com +212005564389 Ahmad Orapy st
City Postal code Country Position/Affiliation
Beni Suef 62511 Egypt Biochemistry Division, Chemistry Department, Faculty of Science, Beni-Suef University, Egypt
REPORTING
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Changes to trial information