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.: PACTR202304590853621 Date of Approval: 05/04/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact of Insulin Bolus Reduction on Postprandial Blood Glucose Variations During Continuous and Intermittent Exercise in Patients with Type 1 Diabetes
Official scientific title Impact of insulin bolus reduction on blood glucose variation during two types of exercise (continuous vs intermittent) performed in the postprandial period in living patients with type 1 diabetes
Brief summary describing the background and objectives of the trial This clinical trial aims to investigate the impact of reducing the insulin bolus during two types of exercise (continuous vs intermittent aerobic exercise) performed in the postprandial period and its effect on glycemic variability in patients with type 1 diabetes (T1DM). The study will be conducted on 15 participants of heterogeneous sex (women and men) aged 18 years or older, who have been diagnosed with T1DM for at least one year, are using multiple daily injections (MDI) for at least three months, and have an HbA1c level of ≤ 12% (108 mmol/mol). Participants with clinically significant microvascular complications, recent macrovascular events, anemia or other abnormal blood test results, pregnancy, recent severe hypoglycemia, and those who are non-compliant will be excluded from the study. The study will take place at the Hospital Hedi CHAKER- Endocrinology – Diabetology Department of the CHU of SFAX. During the admission visit, a thorough examination of the diabetic patient's condition will be performed, including a medical history, blood samples to measure HbA1C levels, measurements of height, weight, body composition, and aerobic physical condition. Participants will also complete six questionnaires. The study aims to observe the impact of reducing the insulin bolus during continuous and intermittent aerobic exercise on glycemic variability in T1DM during and after exercise.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) REDBOL1
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/05/2023
Actual trial start date
Anticipated date of last follow up 10/06/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 15
Actual target sample size (number of participants)
Recruitment status Active, not 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group RED50 Bolus Reduction by 50% 90 minutes before exercise until the end of the exercise Ninety minutes after a meal, they will performe in randomized order one the following exercises: the experiment will consist of 4 intervention visits per participant, each preceded 24 to 48 hours earlier by an intervention visit: • Moderate continuous exercise on an ergocyle with a total bolus • Moderate continuous exercise on an ergocycle with a 50% reduced bolus • Intermittent exercise on an ergocycle with a total bolus • Intermittent exercise on an ergocycle with 50% reduced bolus 15
Control Group RED100 Full Bolus 90 minutes before exercise until the end of exercise Ninety minutes after a meal, they will performe in randomized order one the following exercises: the experiment will consist of 4 intervention visits per participant, each preceded 24 to 48 hours earlier by an intervention visit: • Moderate continuous exercise on an ergocyle with a total bolus • Moderate continuous exercise on an ergocycle with a 50% reduced bolus • Intermittent exercise on an ergocycle with a total bolus • Intermittent exercise on an ergocycle with 50% reduced bolus 15 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age ≥ 18 years heterogeneous sex (women and men), duration of diabetes ≥ 1 year, using multiple daily injections (MDI) for a least 3 months, HbA1c result (less than 2 months) ≤ 12% (108 mmol/mol). presence of clinically significant microvascular complications: nephropathy (glomerular filtration rate <40 ml/min), neuropathy (gastroparesis specifically), or proliferative retinopathy, recent macrovascular events (<3 months), anemia or other abnormal blood test results, pregnancy, recent severe hypoglycemia (<2 weeks) , a medical situation that could interfere with the protocol Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 55 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 17/06/2022 CPP SUD
Ethics Committee Address
Street address City Postal code Country
Bd Majida Boulila, SFAX 3029 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Decrease in plasma glucose levels during exercise (difference between glucose levels at the beginning of the exercise and the lowest glucose levels from the start of the exercise until the end of exercise). during and after execise
Secondary Outcome Secondary comparisons and endpoints For the exercise period only: 1) Percentage of time of plasma glucose levels spent below 4 mmol/L; 2) Decremental area under the curve (AUC) of plasma glucose levels; 3) AUC of plasma glucose levels < 4 mmol/L; 4) Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L and < 3.5 mmol/L; 5) Number of patients requiring an oral treatment for hypoglycemia; 6) Total number of hypoglycemia episodes requiring treatment; 7) Percentage of time of plasma glucose levels spent > 10 mmol/L; 8) Percentage of time of plasma glucose levels spent in target defined as between 4-10 mmol/L; 9) Mean time (minutes) to the first hypoglycemic event during the exercise period; 10) Amount of CHO needed to treat a hypoglycemic event. 11) Muscle vasodilatation. For the post-exercise period: 1) In the 4 hours following the exercise: a. Percentage of time of sensor glucose levels spent between 4 and 10 mmol/L; b. Percentage of time of sensor glucose levels spent < 4 mmol/L; c. Percentage of time of sensor glucose levels spent > 10 mmol/L; d. AUC of sensor glucose levels < 4 mmol/L; e. Number of patients requiring an oral treatment for hypoglycemia; f. Total number of hypoglycemia episodes requiring treatment; g. Total amount of CHO needed to treat hypoglycemic events. 2) From the end of exercise until next morning (6:00): a. Percentage of time of sensor glucose levels spent between 4 and 10 mmol/L; b. Percentage of time of sensor glucose levels spent < 4 mmol/L; c. Percentage of time of sensor glucose levels spent > 10 mmol/L; d. AUC of sensor glucose levels < 4 mmol/L; e. Number of patients requiring an oral treatment for hypoglycemia; f. Total number of hypoglycemia episodes requiring treatment; during and after exercise
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hospital Hedi CHAKER Route El Ain, Km 0.5 Sfax 3000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
May Lab 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 Eugene Avinee
City Postal code Country Position/Affiliation
Loos 59120 France PhD
Role Name Email Phone Street address
Scientific Enquiries Mohamed Amine Bouzid bouzid.mohamed-amine@hotmail.fr 22062275 route aeroport
City Postal code Country Position/Affiliation
Sfax 3000 Tunisia PhD
Role Name Email Phone Street address
Public Enquiries Warda Lahoual wardalahouel.doc@gmail.com +21692617461 route aeroport
City Postal code Country Position/Affiliation
Sfax 3000 Tunisia MSC
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