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.: PACTR202401506460143 Date of Approval: 09/01/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Metformin exercise interaction on glycemic control in patients with prediabetes and recent onset diabetes
Official scientific title Metformin exercise interaction on glycemic control in patients with prediabetes and recent onset diabetes
Brief summary describing the background and objectives of the trial Exercise and metformin are the first line therapies used for the treatment and to some extent the prevention of type 2 diabetes. Both interventions improve glycemic control and cardiovascular risk factors, but little is known about their long term interactive effects on these parameters. The Aim of this project wasto investigate the combined effect of these interventions on glucose metabolism, glycemic control, and cardiovascular risk factors.
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 15/05/2023
Actual trial start date 15/05/2023
Anticipated date of last follow up 15/05/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
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 Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo exercise group 2 capsule of 500mg starch per day + exercise 500 Kcal at 60 % VO2 max 5 weeks This an active control group to which subjects will be randomized. In this group subjects will receive a placebo treatment consisting of 2 capsules of 500mg starch per day and exercise intervention designed to expend 500 Kcal per day at 60 % VO2 peak five days per week for a 5week-period 20 Active-Treatment of Control Group
Experimental Group Exercise metformin group 2 capsule of 500mg Metformin per day + exercise 500 Kcal at 60 % VO2 max 5 weeks In this group subjects will receive a placebo treatment consisting of 2 capsules of 500mg Metformin per day and exercise intervention designed to expend 500 Kcal per day at 60 % VO2 peak five days per week for a 5week-period 20
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) 19 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 08/01/2020 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 Disposition index - Beta-cell function Before intervention and after intervention
Primary Outcome Mean 120min OGTT derived glucose Before and after intervention
Primary Outcome Glycated Albumin Before and after intervention
Secondary Outcome Insulin sensitivity Before and after intervention
Secondary Outcome Mean 120min OGTT-derived insulin Before and after intervention
Secondary Outcome Mean 120min OGTT-derived C-peptide Before and after intervention
Secondary Outcome Insulin secretion rate Before and after intervention
Secondary Outcome VO2 peak Before and after intervention
Secondary Outcome Maximal fat oxidation Before and after intervention
Secondary Outcome Triglycerides Before and after intervention
Secondary Outcome LDL-cholesterol Before and after intervention
Secondary Outcome Total cholesterol Before and after intervention
Secondary Outcome HDL cholesterol Before and after intervention
Secondary Outcome Weight Before and after intervention
Secondary Outcome Body composition Before and after intervention
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
Department of biochemistry Sahloul university hospital Sahloul Hammam Sousse 4002 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Biochemistry Department Sahloul University Hospital Sahloul Hamam 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 Nouvelle cite
City Postal code Country Position/Affiliation
Msaken 4070 Tunisia Professor
Role Name Email Phone Street address
Public Enquiries Jabeur Methnani jabeur.methnani@gmail.fr +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