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.: PACTR201801002942163 Date of Approval: 04/01/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Exercises and fatty liver
Official scientific title Factors affecting response of lipids, estradiol level and liver size to diet and high intensity interval training in postmenopausal women with fatty liver
Brief summary describing the background and objectives of the trial Lifestyle change via diet and exercise is the first line of treating fatty liver. Objectives:To determine the response of lipids, estradiol level and liver size to diet and high intensity interval training (HIIT) in postmenopausal women with non-alcoholic fatty liver
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Non-alcoholic fatty liver
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/01/2015
Actual trial start date 01/01/2015
Anticipated date of last follow up 01/01/2017
Actual Last follow-up date 01/01/2017
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 60
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 computer software program sealed opaque envelops Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group low calorie Diet 12 weeks All participants followed a calorie-restricted diet that was moderately low in fat with a recommended macronutrient distribution of 55% carbohydrate, 15% protein, and 30% fat. 30 Active-Treatment of Control Group
Experimental Group low calorie diet and high intensity interval training 3 times/week 12 weeks participants performed a 5 min warm-up period at an intensity corresponding to 65¿75% of heart rate maximum (HRmax) before walking four intervals of 4 min length at 85¿95% of HRmax. The HIIT intervals were interspersed by 3 min periods of walking at 65¿75% of HRmax. Participants ended each session with a 3 min cool down period at 65¿75% of HRmax amounting to a total exercise time of 33 min. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-All women were diagnosed with hepatic steatosis via ultrasonography. Ultrasonographic findings included the presence of diffuse increases in echogenicity of liver parynchyma characterized by the absence of hyperechoic walls of portal vein radicals and absence of a proper interface between the diaphragm and liver. -All postmenopausal women demonstrated mild hepatomegaly (liver size >16-18 cm) -They had been in menopause >3 years. - Age range of women was between 50 to 60 years. -All women demonstrated a BMI >30 kg/m2. Exclusion criteria for postmenopausal women included: --Hypothyroidism Ischaemic heart disease (IHD) Kidney disease Diabetes Secondary causes of liver disease including ethanol abuse, drugs promoting hepatic steatosis Various surgical procedures enhancing NAFLD Using hormone replacement therapy (HRT) or antidiabetic medications. 50 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 13/05/2015 Research Ethical Committee
Ethics Committee Address
Street address City Postal code Country
7Ahmed ElZayat st. Been Elsaryat Dokki, Giza, Egypt 12622 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Weight, Body mass index at starting of the study and after 12 weeks of treatment
Secondary Outcome lipids including triglycerides, high density lipoprotein, low density lipoprotein, triglycerides at starting and after 12 weeks of treatment
Secondary Outcome liver size at starting and after 12 weeks of treatment
Secondary Outcome Serum estradiol level at starting and after 12 weeks of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Research Center 7 Ahmed ElZayat st., Been Elsarayat Dokki, Giza 12622 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
No source of funding
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Abeer ELDeeb Ahmed ELZayat st., Been ElSarayat Dokki, Giza 12622 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hany Elsisi 7 Ahmed ElZayat st., Been Elsarayat Dokki, Giza 12622 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abeer ElDeeb beroeldeeb@yahoo.com +201001811588 7 Ahmed ElZayat street
City Postal code Country Position/Affiliation
Dokki 12622 Egypt Department of Physical Therapy, Faculty of Physical Therapy, Cairo University
Role Name Email Phone Street address
Public Enquiries Abeer ElDeeb beroeldeeb@yahoo.com +201001811588 7Ahmed ElZayat, Been ElSarayat
City Postal code Country Position/Affiliation
Dokki 12622 Egypt Department of Physical Therapy for Women's Health, Faculty of Physical Therapy, Cairo University
Role Name Email Phone Street address
Scientific Enquiries Abeer ElDeeb beroeldeeb@yahoo.com +201001811588 7 Ahmed ElZayat street,Been ElSarayat
City Postal code Country Position/Affiliation
Dokki 12622 Egypt Department of Physical Therapy for Women's Health, Faculty of Physical Therapy, Cairo University
REPORTING
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