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.: PACTR202408721579454 Date of Approval: 12/08/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Insulin sensitivity and testosterone hormone response to aerobic exercise versus added sugar elimination in PCO women
Official scientific title Insulin sensitivity and testosterone hormone response to aerobic exercise versus added sugar elimination in PCO women
Brief summary describing the background and objectives of the trial Ketosis (KD) can enhance various anthropometric and biochemical parameters in patients with polycystic ovary syndrome (PCOS), including luteinizing hormone (LH), follicle-stimulating hormone (FSH), sex hormone-binding globulin (SHBG), insulin sensitivity, and HOMA index. It also decreases androgenic production and unregulated estrogen production, improving the LH/FSH ratio. Low-calorie ketogenic diets (VLCKD) are effective short-term interventions for weight loss and metabolic profile improvement. In PCOS, hyperandrogenic environments promote post-pubertal neuroendocrine dysfunction, leading to increased luteinizing hormone (LH) release and decreased FSH release. Insulin plays a key role in metabolic homeostasis, ion and amino acid transport, cell proliferation, differentiation, and death. Insulin resistance is a mechanistic factor in cardiovascular risk factors and has been identified as an independent factor for CV disease incidence. Exercise training can improve sympathetic nervous system control and reduce sympathetic activity in conditions characterized by insulin resistance. The aim ot the trial is to assess the insulin sensitivity response and testosterone hormone to aerobic exercise versus added sugar elimination in PCO women.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied polycystic ovary syndrome
Purpose of the trial Treatment: Devices
Anticipated trial start date 25/10/2024
Actual trial start date
Anticipated date of last follow up 22/02/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
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 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 Group I 3 months perform a specialized programme of aerobic exercise. the exercise protocol was applied based on the study by Zainab A et al., 2017. 20
Experimental Group group II 3 months perform specialized programme of added sugar elimination 20
Control Group group III 3 months perform the same programme of aerobic exercise combined with the same programme of added sugar elimination 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
sedentary overweight or obese female aged 25- 40 years old with PCOS with low insulin sensitivity levels with BMI of 26-40 all were diagnosed as having a high normal or mildly elevated levels of HOMA-IR patients with orthopaedic disorders that could impede the ability to walk or exercise cardiac diseases that could interfere with their ability to exercise Adult: 19 Year-44 Year 25 Year(s) 40 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 04/06/2024 research ethical committee faculty of physical therapy cairo university
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat Traffic, Ad Doqi, Al Giza giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Concentration of free testosterone and HOMA-IR were measured. after 12 weeks from starting the management programme
Secondary Outcome comparison between groups after 12 weeks from starting the management programme
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy outclinics El-Tahrir st. - in front of Ben El- Sarayat Traffic, Ad Doqi, Al Giza giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
own resources 4 sherif st giza giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor joseph wageeh 4 sherif st giza giza Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator joseph wageeh saweres josephwageeh83@gmail.com +201226568632 4 sherief st giza
City Postal code Country Position/Affiliation
giza Egypt lecturer of physical therapy basic science department suez canal university
Role Name Email Phone Street address
Public Enquiries christen mohareb joseph.saweres@gmail.com 01127425627 4 sherief st giza
City Postal code Country Position/Affiliation
giza Egypt general manager of research and outclinics
Role Name Email Phone Street address
Scientific Enquiries ehab aly eabdallah@horus.edu.eg +201223674916 tahrir st cairo
City Postal code Country Position/Affiliation
cairo Egypt lecturer of physical therapy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we will share the deidentified IPD that makes our summarised results of the trial after finishing the study by uploading the raw data. Informed Consent Form,Statistical Analysis Plan one year the criteria will be accessed by the puplication of the trial in international journal
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