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.: PACTR201407000856135 Date of Approval: 16/07/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Prevention effect of fenofibrate/pioglitazone in obese diabetic patients
Official scientific title Effect of fenofibrate alone and in combination on serum sirtuin 1 and fetuin A levels
Brief summary describing the background and objectives of the trial we are studying the effect of fenofibrate alone and in combination with pioglitazone on serum sirtuin 1 and fetuin A in obese postmenopausal females with type 2 diabetes mellitus
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,T2DM, obesity
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/08/2014
Actual trial start date 01/08/2014
Anticipated date of last follow up 01/10/2014
Actual Last follow-up date 01/10/2014
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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
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 fenofibrate 160 mg/day 8 weeks prevention 20
Experimental Group fenofibrate/pioglitazone 160 mg/day and 15 mg/day 8 weeks prevention 20
Experimental Group fenofibrate 160 mg/day 8 weeks fenofibrate to obese patients 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Subjects suffering from type 2 DM for at least 5 years and body mass index (BMI) > 30 for diabetic patients groups, Over 50 years of age for females, No definite indication for receiving, and no contraindication to receiving fenofibrate (and pioglitazone for Group 2) in addition to their existing therapy. Subjects with type 1 diabetes, Allergy to any fibrate drugs, Allergy or contraindication for pioglitazone drug (for Group 2), History of pancreatitis or pulmonary embolism or deep venous thrombosis, Use of any other investigational agents in last 8 weeks, Unstable condition including recent MI, heart failure, prior organ transplant, severe renal or liver dysfunction, history of myositis or untreated hypothyroidism, Pregnancy and lactation. 50 Year(s) 90 Year(s) Female
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 01/07/2014 faulty of pharmacy, ain shams university
Ethics Committee Address
Street address City Postal code Country
african union organization st. cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome serum sirtuin 1 level before intervention and after 8 weeks of intervention
Secondary Outcome serum fetuin A level before intervention and after 8 weeks of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
national institute of diabetes and endocrinology 16 El Kasr El Aini St. Cairo 11411 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self-funding african union organization st. cairo 11562 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of pharmacy, ain shams university african union organization st. Cairo 11562 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hala O. El-mesallamy african union organization st. Cairo 11562 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Noureldein m.hussein@pharma.asu.edu.eg 00201004684408 african union organization
City Postal code Country Position/Affiliation
cairo 11562 Egypt TA department of biochemistry
Role Name Email Phone Street address
Public Enquiries Mohamed Noureldein m.hussein@pharma.asu.edu.eg 00201004684408 african union organization
City Postal code Country Position/Affiliation
cairo 11562 Egypt TA department of biochemistry
Role Name Email Phone Street address
Scientific Enquiries Hala El mesallamy hala-elmesallamy@pharma.asu.edu.eg 00200234598733 african union organization
City Postal code Country Position/Affiliation
cairo 11562 Egypt professor of biochemistry, faculty of pharmacy, ain shams university
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information