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.: PACTR202203690920424 Date of Approval: 28/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title timing of metformi administration and exercise
Official scientific title Effect of pre-meal metformin with or without an acute exercise bout on postprandial lipemia in metabolic syndrome patients
Brief summary describing the background and objectives of the trial This study will investigate whether pre-meal metformin administration is superior to metformin administration with meal in metabolic syndrome patients. A second aim of this study is to explore if the addition of one exercise bout to pre-meal metformin coud have additive benefits.
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 Prevention
Anticipated trial start date 24/02/2022
Actual trial start date 01/03/2022
Anticipated date of last follow up 08/04/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 15
Actual target sample size (number of participants) 13
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
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 Administration of Metformin with a test meal 1000mg One day one dose of metformin (1000mg) with a test meal 15 Active-Treatment of Control Group
Experimental Group Administration of Metformin 30 minutes prior to a test meal on dose of metformin (1000mg) One day on dose of metformin (1000mg) taken 30 minutes prior to a meal test 15
Experimental Group Acute exercise with metformin administred 30 minutes prior to a test meal in the next day Exercise: 700 Kcal at 60% of VO2peak + metformin 1000 mg one day each One exercise bout designed to expend 700 Kcal at 60% of VO2peak + metformin (1000 mg) administered 30 minutes prior to a test meal in the next day 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) 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 18/01/2020 Farhat hachad university hospital 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 Postprandial triglycerides -30, 0, 15, 60, 120, 180 and 240 minutes after meal ingestion
Secondary Outcome Total cholesterol -30, 0, 15, 60, 120, 180 and 240 minutes after meal ingestion
Secondary Outcome LDL-cholesterol -30, 0, 15, 60, 120, 180 and 240 minutes after meal ingestion
Secondary Outcome HDL-Cholesterol -30, 0, 15, 60, 120, 180 and 240 minutes after meal ingestion
Secondary Outcome Glucose -30, 0, 15, 60, 120, 180 and 240 minutes after meal ingestion
Secondary Outcome Insulin -30, 15, 60 and 120, minutes after meal ingestion
Secondary Outcome Metformin side effects -30, 0, 15, 60, 120, 180 and 240 minutes after meal ingestion
Secondary Outcome Perceived appetite sensations -30, 0, 15, 60, 120, 180 and 240 minutes after meal ingestion
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Facuty of medicine of sousse Rue Mohamed Karoui Sousse - 4002 Tunisie Sousse 4002 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Biochemistry Department Sahloul University Hospital sahloul Sahloul 4054 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine of sousse Mohamed Karoui Sousse 4002 Tunisia University
Primary Sponsor Sahloul university hospital Department of biochemistry Sahloul, Hammam sousse 4001 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 Nouvelle cite
City Postal code Country Position/Affiliation
Msaken 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 a All of the individual participant data collected during the trial, after deidentification will be shared within the 3 months following study publication Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol within 3 months of study publication Researchers who provide a methodologically sound proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://journals.sagepub.com/doi/full/10.1177/10742484231156318 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