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.: PACTR202306776991260 Date of Registration: 26/06/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Diurnal Variation of Maximal Fat Oxidation in metabolic syndrome patients
Official scientific title Circadian Variation of Maximal Fat Oxidation in metabolic syndrome patients
Brief summary describing the background and objectives of the trial Insulin resistance states, such as type 2 diabetes mellitus and metabolic syndrome (MetS), are characterized by mitochondrial dysfunction (MitoD) and poor capacity to oxidize fat. Furthermore, those patients with T2DM and MetS are overly reliant on Carbohydrates derived energy sources and possess limited ability to transition between Carbohydrate oxidation and FAT both at rest and during exercise, a state commonly known as metabolic inflexibility. In human adipocytes, genes implicated in fatty acid metabolism show transcriptomic rhythmicity, indicating lipid homeostasis is under circadian control. Several lines of evidence suggest that metabolic genes are directly under control of the clock machinery. In line with this transcriptomic data, it has been demonstrated that maximal fat oxidation (MFO) and the intensity at which MFO occurs is higher in the afternoon than in the morning in non-athlete male students in untrained normal-weight, athletes and obese individuals, but not in young health women. This is particularly interesting in the context of weight loss programs because timing exercise to the afternoon period may result in greater weight loss. Therefore, this study aims to evaluate whether there are diurnal variations in maximal fat oxidation in metabolic syndrome patients.
Type of trial CCT
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 10/06/2023
Actual trial start date 28/06/2023
Anticipated date of last follow up 28/06/2023
Actual Last follow-up date 28/04/2023
Anticipated target sample size (number of participants) 15
Actual target sample size (number of participants) 15
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
Crossover: all participants receive all interventions in different sequence 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
Control Group morning condition N/A 40 minutes Performance of a submaximal exercise test in the morning, where the exercise intensity will gradually increase from 20% up to 60% of the maximum power output determined during a previous maximal exercise test. 15 Active-Treatment of Control Group
Experimental Group Afternoon condition N/A 40 minutes Performance of a submaximal exercise test in the afternoon, where the exercise intensity will gradually increase from 20% up to 60% of the maximum power output determined during a previous maximal exercise test. 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Increased waist circumference (≥102 cm in men; ≥88 cm in women) Elevated triglycerides (≥150 mg/dl), or on medication for treating the condition Reduced HDL-cholesterol (<40mg/dl in men, <50 mg/dl in women), or on medication for treating the condition High blood pressure (≥130 mmHg systolic or ≥85mmHg diastolic), or on medication for treating the condition Elevated fasting glucose (≥100 mg/dl), or on medication for treating the condition Any condition that counter-indicate exercise Patients under glucose lowering agents Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 29 Year(s) 64 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 23/06/2023 Faculty of medicine of sousse ethics committee
Ethics Committee Address
Street address City Postal code Country
RUE IBN ELJAZZAR SOUSSE, SOUSSE 4002 Sousse 4002 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Maximal fat oxidation Morning and afternoon
Secondary Outcome Lipox max Morning and afternoon
Secondary Outcome Heart rate Morning and afternoon
Secondary Outcome Respiratory quotient Morning and afternoon
Secondary Outcome VO2 peak morning
Secondary Outcome Resting energy expenditure morning
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine of sousse Rue Mohamed Karoui Sousse 4002 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Biochemistry Department Sahloul University Hospital Sahloul Sahlool 4054 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sahloul university hospital Department of biochemistry Sahloul, Hammam sousse 4002 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ezdine Bouhlel Ezdine_sport@yahoo.fr +21626339239 Nouvell cite
City Postal code Country Position/Affiliation
Msaken 4070 Tunisia Professor
Role Name Email Phone Street address
Public Enquiries Jabeur Methnani Jabeur.methnani@gmail.com +21693201456 Nouvelle Cite
City Postal code Country Position/Affiliation
Beni kalthoum 4016 Tunisia Researcher
Role Name Email Phone Street address
Scientific Enquiries Jabeur Methnani jabeur.methnani@gmail.com +21693201456 Nouvelle cite
City Postal code Country Position/Affiliation
Beni kalthoum 4016 Tunisia Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Authors declare that All of the individual participant data collected during the trial, after deidentification will be shared within the 3 months following study publication Study Protocol within the 3 months following study publication Researchers who provide a methodologically sound proposal
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