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.: PACTR202305888250839 Date of Approval: 30/05/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Cryolipolysis On Cardiovascular Risk Factors In Obese Hypertensive Post Menopausal Women
Official scientific title Effect Of Cryolipolysis On Cardiovascular Risk Factors In Obese Hypertensive Post Menopausal Women
Brief summary describing the background and objectives of the trial Hypertension is a condition in which the blood vessels have persistently raised pressure. Blood pressure is created by the force of blood pushing against the walls of blood vessels as it is pumped by the heart. The higher the pressure is, the harder the heart must pump (WHO, 2015). Hypertension is a risk factor for stroke and heart diseases (Matthews, 2017).It was reported that, after age 50, about 30-50% of women develop hypertension (more than 140/90 mmHg) (Matthews, 2017). The prevalence of hypertension in postmenopausal women is higher than in men because the age-related increases are more rapid in women than in men. In the world, in general, 25% of adult women are hypertensive (Yanes and Reckelhoff, 2018). Cryolipolysis is a new, noninvasive treatment option that may be of benefit in the treatment of excess adipose tissue after menopause (Nasser et al., 2017). It produced nearly reduction in waist circumference and skin folds and can be used for body contouring (ELdesoky et al., 2019). During menopause due to estrogen deficiency, there is an increase in body weight and redistribution of body fat leading to central or visceral obesity. The fat is concentrated at the waist resulting in abdominal obesity. Also, there is increase in blood cholesterol level, low density lipoprotein (LDL), triglyceride (TG) and highly significant decrease in high density lipoprotein (HDL) (Kumar, 2018; Arnold, 2019). All of that are important risk markers of cardiovascular disease, the major cause of death among postmenopausal women (Zhang, 2020). The purpose of this study is to determine the effect of cryolipolysis on cardiovascular risk factors in obese hypertensive postmenopausal women.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Musculoskeletal Diseases,Nutritional, Metabolic, Endocrine,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied post menopause
Purpose of the trial Treatment: Other
Anticipated trial start date 25/12/2022
Actual trial start date 25/12/2022
Anticipated date of last follow up 01/01/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status 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 a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group diet and aerobic exercises 3 sessions per week for 3 months 3 months dash diet and aerobic exercise using treadmill 20 Active-Treatment of Control Group
Experimental Group cryolipolys and diet and aerobic exercises 1 session per week for 3 months 3 months cryolipolysis on abdomen and dash diet and aerobic exer4cises using treadmiil 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The women will be selected according to the following criteria: • The age will range from 50 to 60 years. • They will experience menopause at least 3 years. • The women in the study will be diagnosed as having hypertension. • Their blood pressure must be range from 140/90 to 180/110 mmHg. • They must receive antihypertensive drug (Concor 5 mg). • Body mass index (BMI) will range from 30 to 34.9 kg/m2. • All women will have abdominal obesity; their abdominal circumference will be >90cm. • Waist hip ratio will be >0.85. Patients will be excluding from this study for any of the following cases: • Smokers, athletic women. • Anemia, diabetes, any cardiorespiratory diseases, malignancy. • Eczema or dermatitis, skin disease, scar, hernia in the treatment area. • Suspicious cutaneous lesions, history of keloids or hypertrophic scarring, infection, pain or abscess in the treatment area, presence of tattoos or body piercing in the treatment area, autoimmune disorders. • Presence of pacemaker or metallic implants in the treatment area. • Receiving anti-depressant, any hormonal replacement therapy, or any medication to reduce their body weight. • Previous operation in the abdominal region. Middle Aged: 45 Year(s)-64 Year(s) 53 Year(s) 60 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 02/08/2022 Ethics committee of faculty of physical therapy cairo university
Ethics Committee Address
Street address City Postal code Country
7ty ahmed elzayat st bien elsrayat,eldokkii,giza giza 12511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome lipid profile immediate before starting treatment and immediate after ending treatment
Secondary Outcome blood pressure immediate before starting treatment and immediate after ending treatment
Primary Outcome Body Mass Index immediate before starting treatment and immediate after ending treatm
Secondary Outcome Skin Fold immediate before starting treatment and immediate after ending treatment
Secondary Outcome Waist - Hip Ratio immediate before starting treatment and immediate after ending treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ethics committee of Faculty of physicai therapy cairo university 7th ahmed elzayat st , bien elsaryat, eldokki, giza Giza 12511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded 7th Ahmed ElZayat St. Bein ElSarayat, ElDokki, Giza, Egypt Giza 12618 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy cairo university 7th Ahmed ElZayat St. Bein ElSarayat, ElDokki, Giza, Egypt Giza 12618 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Soheir Mahmoud ElKosery 7th ahmed elzayat st bien elsarayat, eldokkii, giza giza 12618 Egypt
Abeer Mohamed ElDeeb 7th ahmed elzayat st bien elsarayat, dokkii, giza giza 12618 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Norhan Nagy drnorhannagy89@gmail.com +201002869690 7th ahmed elzayat st bien elsarayat,dokkii,giza
City Postal code Country Position/Affiliation
giza 12618 Egypt assisstant lecturer
Role Name Email Phone Street address
Scientific Enquiries Soheir ElKosery d_elkosery@yahoo.com 01100691280 7th ahmedelzayat st bein elsarayat,dokkii,giza
City Postal code Country Position/Affiliation
giza 12618 Egypt Professor
Role Name Email Phone Street address
Public Enquiries Abeer Eldeeb beroeldeeb@yahoo.com 01001811588 7th ahmed elzayat st bein elsarayat, dokkii, giza
City Postal code Country Position/Affiliation
Giza 12618 Egypt Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data that underlie the results reported in this article, after identification (Text, tables, figures and appendices) Statistical Analysis Plan,Study Protocol six months following puplication anyone who wishes to access the 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