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.: PACTR202004826694476 Date of Approval: 21/04/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title RESPONSE OF GLYCEMIC CONTROL TO LOW LEVEL LASER THERAPY IN TYPE 2 DIABETIC PATIENTS.
Official scientific title RESPONSE OF GLYCEMIC CONTROL TO LOW LEVEL LASER THERAPY IN TYPE 2 DIABETIC PATIENTS.
Brief summary describing the background and objectives of the trial BACKGROUND: Diabetes mellitus is a metabolic disease characterized by hyperglycemia resulting from defects in insulin secretion, insulin action, or both. The chronic hyperglycemia of diabetes is associated with long term damage, dysfunction and failure of various organs, especially the eye, kidney, nerves and blood vessels (American Diabetes Association, 2011). The International Diabetes Federation (IDF) has identified Egypt as the ninth Country in the world according to the number of type two diabetic patients (DM2). The prevalence of DM2 in Egypt was almost tripled over the last 2 decades. The use of low level laser to reduce pain, inflammation and edema, to promote wound, deeper tissues and nerves healing, and to prevent tissue damage the effect of visible light on mammalian cells, including cytochrome c oxidase (with absorption peaks in the Near Infrared (NIR)). Mitochondria are thought to be a likely site for the initial effects of light, leading to increased ATP production, modulation of reactive oxygen species, and induction of transcription factors. These effects in turn lead to increased cell proliferation and migration (particularly by fibroblasts) Farivar et al., 2014). The experimentations and clinical studies in the fields of diabetology , quantum medicine, pathologic anatomy and physiology have led us to believe that any disease is reversible, depending upon the functional level and the extent of organic damage (Ramdawon, 1999). The quantum energy of laser rays is capable of stimulating and causing the regeneration of pancreatic tissues (Ramdawon, 1999). Objectives: To evaluate the response of glycemic control to low level laser therapy in type 2 diabetic patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/06/2019
Actual trial start date 06/06/2019
Anticipated date of last follow up 16/10/2019
Actual Last follow-up date 10/12/2019
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
No:P.T.REC/012/001808
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 Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group low level laser therapy and hypoglycemic drug Site: 10 individual laser beams for the wrist to be contact with redial and ulnar arteries; The wavelength: 650 nm. The power: output is 2-5 mW. Mood: continuous mood. The duration: 30 min at the morning. Treatment period: 3 time /week for 12 weeks. Patient condition: The patient fasted for four hours prior to the laser treatment to avoid increase of blood glucose level. Laser watch parameters Site: 10 individual laser beams for the wrist to be contact with redial and ulnar arteries; The wavelength: 650 nm. The power: output is 2-5 mW. Type of beam: red laser beam. Mood: continuous mood. 30
Control Group hypoglycemic medications Individual for each diabetic patient daily insulin or oral hypoglycemic drugs 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Type II Diabetes mellitus, started more than one year ago. • Both genders. • BMI from 25 kg/m2 to 39.9Kg/m2. • They receive medical therapy for diabetes one year or more ago. • Being clinically stable. • Glycated hemoglobin ≥ 6.5 %. • Fasting blood glucose level > 126 mg/dl. • Two hour Postprandial blood glucose level ≥ 200 mg/dl. . • Patients with unstable glycemic control. • History of uncontrolled cardiovascular complications. • History of malignancy or hemorrhagic diseases. • Patients with a cardiac pacemaker or pregnant women. • Complete destruction of beta cell, (estimated from HOMA test (%B)). • Participants diagnosed with pre-diabetes, gestational diabetes, or type1 diabetes. Middle Aged: 45 Year(s)-64 Year(s) 45 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 03/12/2017 Egyptian National Bioethics Committee
Ethics Committee Address
Street address City Postal code Country
17th Ismael Abou El Fotouh, St. Dokki, Cairo 12615 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Beta cell function (%B). • Insulin sensitivity (%S). • Insulin resistance (%IR). by using HOMA-IR calculator after measuring fasting blood glucose level, fasting C peptide. 3 months
Primary Outcome -Measuring glycated hemoglobin (HbA1c): was recommended as an essential indicator for the monitoring of blood glucose control. The blood HbA1c ≥ 6.5% was considered as diabetes; -Measuring fasting plasma Glucose level (FPG): There was eight hours fasting before test; -Measuring postprandial plasma Glucose level (PPPG): Two hour after eating from FPG test; -Measuring Fasting C peptide level: to detect level of: - acute effect of laser on glycemic control post sessions 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy cairo university. 7 Ahmed El Zayyat St., Bein El Sarayat, Giza In Front Of Giza Traffic Station cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Hend Abd El monaem 7 Ahmed El Zayyat St., Bein El Sarayat, Giza In Front Of Giza Traffic Station Giza 12615 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor dr Bassant Hamdy 7 Ahmed El Zayyat St., Bein El Sarayat, Giza In Front Of Giza Traffic Station Cairo 12615 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Sahier Omer El Khashab AlKaser Al- Aini street Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hend abd El moniem drhendpt@yahoo.com 00201115507195 7 Ahmed El Zayyat St., Bein El Sarayat, Giza In Front Of Giza Traffic Station
City Postal code Country Position/Affiliation
Cairo 12615 Egypt assistant lecturer
Role Name Email Phone Street address
Public Enquiries Hend Abd el moniem drhendpt@ahoo.com 00201115507195 7 Ahmed El Zayyat St., Bein El Sarayat, Giza In Front Of Giza Traffic Station
City Postal code Country Position/Affiliation
Cairo 12615 Egypt assistant lecturer
Role Name Email Phone Street address
Scientific Enquiries Hend Abd El moniem drhendpt@yahoo.com 00201115507195 7 Ahmed El Zayyat St., Bein El Sarayat, Giza In Front Of Giza Traffic Station
City Postal code Country Position/Affiliation
Cairo 12615 Egypt assistant lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes Laser group shows more improvements than control group in fasting blood glucose level and poatprandial blood glucose level which decreased and more improves in fasting C peptide in laser group and it also can enhance acute lowering response of blood glucose level by 22.7 mg/dl 21/04/2020 21/04/2020
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks No link to protocol
Changes to trial information