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.: PACTR202407674459621 Date of Approval: 22/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Insulin senstivity response to aerobic exercise versus added sugar elimination in overweight and obese females
Official scientific title Insulin senstivity response to aerobic exercise versus added sugar elimination in overweight and obese females
Brief summary describing the background and objectives of the trial Insulin regulates metabolic homeostasis, ion and amino acid transport, cell proliferation, and inflammation. Abnormalities in insulin signaling lead to insulin resistance, which contributes to cardiovascular risk factors like diabetes, metabolic syndrome, hypertension, atherosclerosis, obesity, and NAFLD. Insulin resistance also increases cardiovascular disease incidence and negatively impacts clinical outcomes. The sympathetic nervous system's overactivity contributes to insulin resistance. Exercise training improves sympathetic nervous system control and reduces sympathetic activity, especially in conditions like metabolic syndrome and hypertension. The aim of the study is to assess the TNF- alpha response to aerobic exercise versus added sugar elimination.
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 01/08/2024
Actual trial start date
Anticipated date of last follow up 01/11/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 150
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group group I 12 week perform a specialized programme of aerobic exercise 50
Experimental Group group II 12 week perform specialized programme of added sugar elimination 50
Control Group group III 12 week perform the same programme of aerobic exercise combined with the same programme of added sugar elimination 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
sedentary obese female aged 40-60 years old with BMI of 30-40 and all were diagnosed as having a high normal or mildly elevated levels of GTT, 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 Middle Aged: 45 Year(s)-64 Year(s) 40 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 05/03/2024 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 measuring GTT and levels after 6 fasting hours, one hour post prandial and 2 hours post prandial, estimation of 6 hours fasting HOMA-IR done 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 11432 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
own resources 4 sherif st giza giza 12551 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor joseph wageeh 4 sherif st giza giza 12551 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 12551 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 12551 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 11512 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