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.: PACTR201907693335007 Date of Approval: 11/07/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Systemic Effects of Cryolipolysis in Central Obese Women
Official scientific title Systemic Effects of Cryolipolysis in Central Obese Women
Brief summary describing the background and objectives of the trial Independent of total body fat, body fat distribution is an important and established risk factor for atherosclerosis, the risk for acute coronary events cardiovascular disease and Non-Alcoholic Fatty Liver Disease. Precise application of cryo lipolysis triggers the death of adipocytes that are subsequently engulfed and digested by macrophages. So, the aim of this study is to investigate the reshaping effect of cryo lipolysis on lipid profile and liver enzyme as well as weight reduction, body mass index, and Waist Hip ratio in central obese female subjects.
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 01/04/2019
Actual trial start date 01/05/2019
Anticipated date of last follow up 01/08/2019
Actual Last follow-up date 01/10/2019
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Closed to recruitment,follow-up continuing
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group cryo lipolysis three cryolipolysis sessions in addition to the prescribed low caloric dietary regimen. one hour in this group subjects were submitted to three sessions of cryolipolysis every 4 weeks. Temperature of -5º C, was applied on the hypogastrium area, 5 cm below the umbilicus. Variable vacuum function controllable vacuum level: step 1 (low) to step 5 (high), various vacuum pulses, Pulse 1 (continuous) to Pulse 4 continuous mode, slow, middle, fast 630 nm Red LED. Each subject in study group was received cryolipolysis application according to the following steps: Evaluation of vital signs before and after the session (blood pressure, heart rate, pulse rate). Patient was in supine position. Therapist at the at the level of the patient waist beside the bed. Through using test tube (hot and cold) the investigator examined the patient sensation while the patient closed his eyes. Determine the area for cry lipolysis head application by tissue marker just below the umbilicus by 5cm. The treated area was cleaned by. Anti-freezing membrane was applied to the treated area. Cryolipolysis device temperature was settled at -5oC for 60 minutes. Cryolipolysis head over the treated area was stabilized by the patient (Setting -up vacuum according to patient tolerance and head well fixed). After starting the device on, the patient was instructed with safety measures to pull the key off if there is any abnormal sensation intolerable. At the end of the session after 60 min, the device off automatically the therapist removed the cryolipolysis head, and the freezing membrane, any hyperemia or any abnormal skin condition was observed and checked. Stroking massage was performed for 2 minutes at the site of cryo lipolysis. 15
Control Group low calories diet Patients of this group instructed to follow a low dietary regimen designed by the nutritionist, subdivided into 3 well calculated meals. The regimen was changed every week for 12 weeks. Low caloric diet (1200— 1500 cal ): A low caloric diet regimen of recommended dietary allowance about 1200 to 1500 cal/day of balanced diet containing high protein, was prescribed for all the participating subjects in the control and study groups. Low carbohydrate regimen, rich in fruits, vegetables and dietary fibers. The dietary regimen was changed every week. 12 week Patients of this group instructed to follow a low dietary regimen designed by the nutritionist, subdivided into 3 well calculated meals. The regimen was changed every week for 12 weeks. Low caloric diet (1200— 1500 cal ): A low caloric diet regimen of recommended dietary allowance about 1200 to 1500 cal/day of balanced diet containing high protein, was prescribed for all the participating subjects in the control and study groups. Low carbohydrate regimen, rich in fruits, vegetables and dietary fibers. The dietary regimen was changed every week. 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age ranging between 40 and 50 years with body mass index ranging from 35-4Okg/m2, waist-to-hip ratio between 0.8 to 1.0 and Total cholesterol > 200 mg/dl, LDL > 150 mg/dl, and HDL < 45 mg/dl While any patient with previously past history of chronic disease (e.g. diabetes or hypertension), sensory problem and dehydration for any causes or bleeding problem or peptic ulcer and patients receiving weight control drugs was excluded from this study Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 50 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 01/04/2019 Ethical committee of faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
7 ahmed elziat Cairo 0025 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome lipid profile and liver enzyme as well as sub cutaneous fat thickness after 3 months
Secondary Outcome liver enzymes 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of physical therapy 7 ahmed elziat cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Ebrahim Elerian 46 b 77 street . Elmaadi Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ahmed Ebrahim Elerian Elmaadi cairo Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Nabil Mahmoud 7 ahmed Elziat Cairo Egypt
Ayman Elmakaki 7 ahmed Elziat Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Elerian dr_ahmed_elerian77@cu.edu.eg 00201116752333 elmaadi
City Postal code Country Position/Affiliation
Cairo Egypt Ass.Pro. Basic Science Department . Physical Therapy . Cairo University
Role Name Email Phone Street address
Public Enquiries ahmed elerian dr_ahmed_elerian77@yahoo.com 00201116752333 Elmaadi
City Postal code Country Position/Affiliation
Cairo 0025 Egypt Ass.Prof.Cairo University
Role Name Email Phone Street address
Scientific Enquiries ahmed elerian dr_ahmed_elerian77@yahoo.com 00201116752333 Elmaadi
City Postal code Country Position/Affiliation
Cairo 0025 Egypt Ass.Prof.Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes their age ranging between 40 and 50 years with body mass index ranging from 35-4Okg/m2, waist-to-hip ratio between 0.8 to 1.0 and Total cholesterol > 200 mg/dl, LDL > 150 mg/dl, and HDL < 45 mg/dl (Kottagi et al., 2014). While any patient with previously past history of chronic disease (e.g. diabetes or hypertension), sensory problem and dehydration for any causes or bleeding problem or peptic ulcer and patients receiving weight control drugs was excluded from this study. Statistical Analysis Plan,Study Protocol within 12 month of complition of the study controlled , reviewed by corresponding author
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information