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.: PACTR202301667050563 Date of Approval: 27/01/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Exploration of aerobic fitness in uncomplicated obese patients with type 2 diabetes
Official scientific title Exploration of aerobic fitness in uncomplicated obese patients with type 2 diabetes: A focus on respiratory function.
Brief summary describing the background and objectives of the trial Most of the studies concerning aerobic fitness in Type 2 diabetic patients noted a relationship between impaired aerobic fitness and high glycated haemoglobin (HbA1c) levels, reflecting poor glycaemic control. To explain this relationship, the indirect effect of chronically high blood glucose levels on cardiovascular complications - and hence on exercise cardiovascular adaptations - are often mentioned. However, one could wonder if HbA1c could also have a direct impact on aerobic fitness patients with Type 2 diabetes. Haemoglobin glycation may increase its O2 affinity, thus limiting the O2 availability at the muscular level and impairing maximal aerobic power. Moreover, chronic hyperglycaemia might have deleterious effect on muscle and cerebral oxygenation. The aim of this study is to assess the effect of Type 2 diabetes and of HbA1c level on muscular oxygen delivery and use and hence on aerobic fitness.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) FORE2
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 06/02/2023
Actual trial start date
Anticipated date of last follow up 31/03/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 36
Actual target sample size (number of participants) 30
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
Parallel: different groups receive different interventions at same time during study Non-randomised Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group DT2Obese 1 day ( intervention day ) + 2 weeks ( measuring physical activity level by accelerometer and glycemia by continuous glucose monitoring) Behavioral: Incremental maximal exercise The exercise test starts 2-4h after a standardized breakfast. All participants performed a bruce protocol test on the treadmill. Procedure: Spirometry Pulmonary functions will be evaluated with spirometry (FVC, FEV1, FEV1/FVC, PEFR, and MMFR) Procedure: Accelerometry over one week The subjects wear a triaxial accelerometer over one week to assess their usual physical activity level Procedure: Continuous glucose monitoring The participants used continuous glucose monitoring to assess their blood glucose for 14 days Other: Questionnaires Diet questionnaires, quality-of-life questionnaires, physical activity questionnaires 15
Control Group CTRLObese day ( intervention day ) + 2 weeks ( measuring physical activity level by accelerometer and glycemia by continuous glucose monitoring) Behavioral: Incremental maximal exercise The exercise test starts 2-4h after a standardized breakfast. All participants performed a bruce protocol test on the treadmill. Procedure: Spirometry Pulmonary functions will be evaluated with spirometry (FVC, FEV1, FEV1/FVC, PEFR, and MMFR) Procedure: Accelerometry over one week The subjects wear a triaxial accelerometer over one week to assess their usual physical activity level Procedure: Continuous glucose monitoring The participants used continuous glucose monitoring to assess their blood glucose for 14 days Other: Questionnaires Diet questionnaires, quality-of-life questionnaires, physical activity questionnaires 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age18-40 years old, body mass index (BMI) ≥25 kg/m2, stable body weight and diagnosis of T2DM for at least 3 months prior to the study, stable medication doses for at least 1 month for the treatment of T2DM, pregnancy or breastfeeding, type 1 diabetes, secondary diabetes (e.g. cystic fibrosis, steroid induced, etc.), advanced renal failure with a creatinine clearance under 40 ml/min, established coronary heart disease. Adult: 19 Year-44 Year 18 Year(s) 40 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 09/12/2021 Comite ethique Taher Sfar
Ethics Committee Address
Street address City Postal code Country
Hopital taher Sfar Mahdia 5400 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome maximal oxygen uptake at the end of maximal exercise
Secondary Outcome muscle and cerebral oxygenation HHb, Hbtot and HbO2 during maximal exercise
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
TaherSfar 1 Tahar Sfar mahdia 5100 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
My Lab ULR 7369 URePSSS Unite de Recherche Pluridisciplinaire Sport Sante Societe 413 Av Eugene Avinee Loos 59120 France
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Urepsss 413 Av Eugene Avinee Loos 59120 France University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Semah Tagougui semah.tagougui@univ-lille.fr +33648781288 413 Av. Eugene Avinee
City Postal code Country Position/Affiliation
Loos 59120 France ULR 7369 URePSSS
Role Name Email Phone Street address
Public Enquiries Islem Jlali islem.jlali.etu@univ-lille.fr +33784832522 413 Av Eugene Avinee
City Postal code Country Position/Affiliation
Loos 59120 France Urepsss
Role Name Email Phone Street address
Scientific Enquiries Imen Toiuil imenn.touil@gmail.com +21673109000 CHU Mahdia
City Postal code Country Position/Affiliation
mahdia 5400 Tunisia DR
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data collected during the PRACTICAL trial will be shared at 2 years after article publication with no end date Study Protocol The PRACTICAL trial will be shared at 2 years after article publication with no end date Data obtained through this study may be provided to qualified researchers . Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
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