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.: PACTR201510001303413 Date of Approval: 12/10/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Pulsed Magnetic Field Therapy in Diabetes's Type 2 Pancreatic Cells
Official scientific title Effect of Pulsed Magnetic Field Therapy in Diabetes's Type 2 Pancreatic Cells A randomized, Placebo controlled double blind Study.
Brief summary describing the background and objectives of the trial The identification of the factors that disturb insulin release is a priority in pathophysiology of diabetes. Diabetes results from a disorder in carbohydrate metabolism. It is caused by deficiency in the release of insulin and insufficient insulin function or both. It seems that EMF can affect insulin release and glucose level regulation.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied diabities type 2,Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 15/02/2015
Actual trial start date 18/02/2015
Anticipated date of last follow up 25/07/2015
Actual Last follow-up date 29/07/2015
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 38
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 Randomised numbered envelop method envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo group ¿ (sham exposure) sham exposur to magntic field 1 hour sham exposure to electromagentic field 50 HZ 20 Placebo
Experimental Group diabetic 2 group ¿¿ (real exposure). exposed to 50 Hz pulsed electromagntic field (PEMF) 1 hour Subjects exposed to PEMF over the area of abdomen at pancreases site and contralateral site, with frequency 50 Hz, intensity 40 gauss and for duration of 1 hour. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Their ages were between 30:65 years old. diagnosed as type 2 diabetes mellitus by clinical examination and laboratories studies. pacemaker. type 1 diabetes. pregnant diabetic women. 30 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 15/08/2015 faculty of physical therapyethics committee
Ethics Committee Address
Street address City Postal code Country
elgaesh street kaferelshiek 33512 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome fasting and 2 hours post prandial blood glucose levels in addition to fasting and 2 hour post prandial insulin hormone levels fasting and 2 hours post prandial blood glucose levels in addition to fasting and 2 hour post prandial insulin hormone levels for each patient at initial tratment and after 1 month
Secondary Outcome generalized patient heaith at initial evaluation and after 1 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
private clinics of internal medicine elmoharben elgdeda kaferelshiek 33512 Egypt
out patient clinic of kaferelshiek hospital elnaboy elmohandes street kaferelshiek 33412 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of physical therapy elgaesh street kaferelshiek 33512 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy elgesh street kaferelshiek 33512 Egypt University
COLLABORATORS
Name Street address City Postal code Country
mahmoud mohamed ewidea ahmed el ziat street giza 54124 Egypt
Ahmed Ibrahim Elarian faeza kamal cairo 23145 Egypt
farg khalil saidi salem kaferelshiek 54123 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mahmoud ewidea mewidea@hotmail.com 00201288280082 ahmed el ziat street
City Postal code Country Position/Affiliation
giza 54124 Egypt lecteure of physical therapy
Role Name Email Phone Street address
Principal Investigator ahmed elearian dr_ahmed_elarian77@yahoo.com 00201288280082 elahram street from faeza kamal st
City Postal code Country Position/Affiliation
cairo 54312 Egypt lecteure of physical therapy
Role Name Email Phone Street address
Public Enquiries fareg khalil faragkhalil@gmail.com 00201200656532 saidi salem
City Postal code Country Position/Affiliation
kaferelshiek 21345 Egypt Ass. Prof Dr of internal medicine
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information