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.: PACTR202403564047138 Date of Approval: 28/03/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact of Ramadan diurnal intermittent fasting and physical training on glycemic variability, cardiometabolic health and physical performances in type 2 diabetes patients
Official scientific title Effect of chrononutrition and physical activity at different times of the day in person with diabetes: impact on cardiovascular health and functional capacity
Brief summary describing the background and objectives of the trial Diabetes mellitus is a chronic disease characterized by a high blood sugar,resulting from the combination of insulin resistance and insufficient insulin production by the pancreas.In recent decades, there has been an observable increase in the prevalence of type 2 diabetes (DT2).North African countries, such as Tunisia, are now among the countries with the highest incidence rates of diabetes. This event can be attributed to several factors,notably the change in sedentary lifestyle and an unbalanced diet characterized by glucose abundance of.These factors contribute to an increase in hepatic lipogenesis,and inflammation of adipose tissue,liver and skeletal muscles. Intermittent fasting has gained significant attention due to its potential health benefits. Previous studies have demonstrated its effectiveness in managing a wide range of chronic disorders in humans.The fasting can also have mental and physical beneficial effects. Besides, it has been demonstrated that people with diabetes who fasted during Ramadan had a modest weight loss. Ramadan fasting has also been shown to be effective in increasing high-density lipoprotein(HDL) and decreasing glycated hemoglobin(HbA1c) and low-density lipoprotein(LDL) levels.Moreover,previous studies reported the efficacy of Ramadan fasting in improving lipid profile and glycemic metabolism as well as attenuating oxidative stress biomarkers in diabetic patients.In addition,previous studies have shown that combined training (endurance-resistance) presented benefits on carbohydrate and lipid metabolism,as well as on inflammation and antioxidant capacity,in diabetic patients. Studies combining Ramadan fasting with physical exercise are scarce in DT2 patients so their combined effects are still unclear in this population.The aim of this study was to explore the effects of Ramadan fasting associated with self-regulated exercise on glycemic variability,cardiometabolic parameters,sleep quality,and functional capacity in patients with DT2
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 Physical activity and nutrition
Anticipated trial start date 09/03/2024
Actual trial start date 09/03/2024
Anticipated date of last follow up 20/04/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
0579 CPP SUD
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 Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ramadan fasting 4weeks Fasting Ramadan 4Weeks -all participants abstained from all food and drinks (including water) from sunrise to sunset. The daily fasting duration during this study was approximately 16 h 15
Experimental Group Ramadan fasting and physical training -Fasting ramadan 4 weeks -Training 3 sessions/weeks 4Weeks -All participants abstained from food and drinks (including water) from sunrise to sunset. The daily fasting duration during this study was approximately 16 hours and performed endurance and resistance training Befor breaking the fast 15
Control Group CG 4Weeks Participants in this group will neither fast no engage in physical activity 15 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
▪Persons diagnosed w ith type 2 diabetes ▪ 20-60 years old ▪Intending to fast during the month of Ramadan ▪ Stabilized on oral antidiabetic drugs including metformin or sulfonamides for at least 3 less before study ▪ HbA1C > 6,5 mmol.mol-1 ▪ IMC: ≥ 25 kg/m2 ▪ Cardiovascular diseases ▪Uncontrolled hypertension ▪Chronic inflammatoty diseases ▪Cancer ▪ Taking medication (forw eight loss, fat reduction) ▪Taking insulin (for T2D) ▪ A history of iatric bar surgery ▪Pregnant women ▪ People unconscious in case of hypoglycemia. ▪ People w ith severe hypoglycemia ▪ Did not have physical injuries or mobility concerns ▪ not involved in regular physical activity in the 6 months preceding the study. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 60 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 18/01/2024 Committee for the Protection of Persons from the south
Ethics Committee Address
Street address City Postal code Country
Avenue Majida BOULILA 3029 Sfax, Tunisie sfax 3029 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The anthropometric parameters-CGMS-Biochemical reponses -FC-physical performance :6MWT, Test 3 min step test ,30 second biceps curl test ,Unipedal and bipedal postural balance (force plateform), Heart rate varriability analyse (Kubios software), chair test , (lower-extremity muscle strength) pre, in the middle and post ramadan
Secondary Outcome Sleep quality,( actimetry , self-reported daily evaluation of sleep , and the completion of the Pittsburgh Sleep Quality Index questionnaire) , quality of life(Questionnaire SF36),Physical activity readiness(Questionnaire PAR_Q) , (Questionnaire risque of fasting IDF-DAR),Questionnaire caen , Questionnaire (EDE-Q) pre, in the middle and post ramadan
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Endocrinology department of Hadi Chaker University Hospital Road el Ain Km0.5 sfax 3000 Tunisia
Diabete House Habib Bourguiba sfax 3000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Endocrinology department of Hadi Chaker University Hospital Road el Ain Km 0.5 sfax 3000 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Endocrinology department of Hadi Chaker University Hospital Road el Ain Km 0.5 sfax 3000 Tunisia Hospital
Secondary Sponsor Research Laboratory Molecular Bases of Human Pathology LR19ES13 Faculty of Medicine University of Sfax Tunisia Road el Ain km 0.5 sfax 3000 Tunisia University
COLLABORATORS
Name Street address City Postal code Country
Omar Hammouda Avenue of the Republic Paris 92000 France
Dalenda Iben Elwefi Road Gremda km 13 sfax Tunisia
Sonda Jallouli Road Gremda km 3,5 sfax 3032 Tunisia
Kawther Ben Hamed Road Gare Redayef Gafsa Tunisia
Mohamed Ali Hbaieb Route Tunis km 5 sfax 3021 Tunisia
Samah Tagougi 42 Road Paul Duez lille France
Mouna Turki Road el Ain km 0.5 sfax Tunisia
Mouna Mnif Roadel Ain km 0,5 Sfax 3000 Tunisia
Faten Haj Kacem Road el Ain km 0.5 sfax 3000 Tunisia
Fatma Ayadi Road el Ain km 0.5 sfax 3000 Tunisia
Mohamed Ben Hmida Road el Ain km 0,5 sfax 3000 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sirine Miledi sirinemiledi376@gmail.com +21650192500 9 Street Algeria
City Postal code Country Position/Affiliation
Monastir Ksar Hellal 5070 Tunisia Research Laboratory Molecular Bases of Human Pathology LR19ES13 Faculty of Medicine University of Sfax Tunisia
Role Name Email Phone Street address
Principal Investigator Dalenda Iben Elwefi belwefid@gmail.com +21626154522 Road Gremda km 13
City Postal code Country Position/Affiliation
sfax Tunisia Research Laboratory Molecular Bases of Human Pathology LR19ES13 Faculty of Medicine University of Sfax Tunisia
Role Name Email Phone Street address
Scientific Enquiries Omar Hammouda omar.hammouda@parisnanterre.fr +33782931995 Avenue of the Republic
City Postal code Country Position/Affiliation
Nanterre France Interdisciplinary Laboratory in Neurosciences Physiology and Psychology Physical Activity health and Learning
Role Name Email Phone Street address
Scientific Enquiries Sonda Jallouli sondajallouli58@gmail.com +21644188641 road gremda km3
City Postal code Country Position/Affiliation
sfax 3032 Tunisia Doctor in biological sciences of sports and physical activities. Research laboratory Evaluation and Management of Musculoskeletal System Pathologies LR20ES09 Faculty of Medicine University of Sfax
Role Name Email Phone Street address
Public Enquiries Kawthar Ben Hamed K.benhamed99@gmail.com +21624960981 road Gare
City Postal code Country Position/Affiliation
Redayef Gafsa Tunisia Research Laboratory Molecular Bases of Human Pathology LR19ES13 Faculty of Medicine University of Sfax Tunisia
Role Name Email Phone Street address
Public Enquiries Mohamed Ali Hbaieb mohamed.ali.hbaieb@univ-poitiers.fr +21694660000 Route Tunis km 5
City Postal code Country Position/Affiliation
sfax 3021 Tunisia Laboratoire MOVE UR 20296 Poitiers France
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participants data collected during the trial and after deidentification will be shared Informed Consent Form Data will be made available following publication. Access to data can be granted anyone who wishes to access it.
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