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.: PACTR202010677385435 Date of Registration: 19/10/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECT OF CRYOLIPOLYSIS ON APPETITE REGULATION IN CENTRAL OBESE SUBJECTS
Official scientific title EFFECT OF CRYOLIPOLYSIS ON LEPTIN HORMONE IN CENTRAL OBESE SUBJECTS
Brief summary describing the background and objectives of the trial The development of a non-invasive method that operates in the reduction of the fat layer called “cryolipolysis” has been employed for the selective destruction of fat cells. This non-surgical approach uses controlled cooling to decrease subcutaneous fat without damaging surrounding tissues. The purpose of this study to investigate the effect of cryolipolysis on leptin hormone in central obese 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: Other
Anticipated trial start date 11/10/2020
Actual trial start date
Anticipated date of last follow up 14/01/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group cryolipolysis sessions with diet restriction cryolipolysis sessions for 60 minutes one session per month for three months with diet restriction. for three months cryolipolysis sessions for 60 minutes one session per month for three months with diet restriction. 15
Control Group low carbohydrate diet low-carbohydrate diet for three months. low-carbohydrate diet for three months. low-carbohydrate diet for three months. 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusive criteria of patient 1. 30 Central obese subjects. 2. Age was from 30-40 years. 3. BMI was from 30-35 kg/m2 Exclusive criteria of patient: 1. Smokers. 2. Pregnant women. 3. Cardiovascular disease. 4. Musculoskeletal disease. 5. Physical disability. 6. Renal and metabolic diseases. 7. Patient receiving any drug therapy such as lipid lowering therapy , vitamins and antioxidants . 8. women were excluded if they had had a body mass index (BMI) <25 kg/m2 or body fat <25%. Adult: 19 Year-44 Year 30 Year(s) 40 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 09/09/2018 Faculty of physical therapy
Ethics Committee Address
Street address City Postal code Country
7 ahmed elziat st bein srayat Giza. Egypt Giza 11411 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome active ghrelin, leptin concentrations and BMI before and after 3 months of intervention
Secondary Outcome Visual analogue scale measurements Desire to eat, hunger, fullness and prospective food consumption (PFC) were rated immediately before (after a 12 h overnight fast) and at 0, 10, 20, 30, 40, 50 and 60 min after the standardized test meal on a 150mm VAS and body weighing measuring before and after 3 month of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
outpatient clinic of faculty of physical therapy Cairo university 7 ahmed elziat st bein srayat Giza 11411 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Prof.Dr mohamed serag eldein mahgoub 77 shalhoub street ahmed essmat ain shams, Cairo. Egypt Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy Cairo university 7 ahmed elziat st bein srayat Giza 11411 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Nabil Mahmoud AbdelAall 7Ahmed elzyat street bein srayat .Giza .Egypt Giza 11411 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Mostafa drsergany_79@hotmail.com 00201140974442 77 shalhoub st ain shams
City Postal code Country Position/Affiliation
Cairo 11311 Egypt Associate Professor Basic Sciences Department Faculty of Physical Therapy Cairo University and Heliopolis University
Role Name Email Phone Street address
Public Enquiries MAHMOUD MOAWAD awadmahmoud55@yahoo.com 00201094346762 5th settlement new Cairo
City Postal code Country Position/Affiliation
Cairo 11611 Egypt BSc MSc of physical therapy Cairo university
Role Name Email Phone Street address
Scientific Enquiries Nabil Ismail nabil_45@hotmail.com 00201200133988 6 october city
City Postal code Country Position/Affiliation
Giza Egypt Assistant Professor Basic Sciences Department Faculty of Physical Therapy Cairo University.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data summary of results Study Protocol 5 month period of time after publication Controlling access to data
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