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.: PACTR202311864433214 Date of Approval: 06/11/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A comparative study of insulin with metformin in the management of gestational diabetes mellitus at the University of Abuja Teaching Hospital, Abuja
Official scientific title A comparative study of insulin with metformin in the management of gestational diabetes mellitus at the University of Abuja Teaching Hospital, Abuja
Brief summary describing the background and objectives of the trial Background Gestational diabetes mellitus (GDM) is beginning to have significant global burden. This condition is on the rise globally with majority of cases found in low and middle-income countries where access to maternal care is often limited. Given the poor pregnancy outcomes, as well as increasing feto-maternal vulnerability to future diabetes and cardiovascular disorders, there needs to be more pharmacological options in the armamentarium of the treatment of GDM. Although not used as routinely as insulin, metformin a biguanide oral antidiabetic agent is beginning to have greater attention and utilization in the management of GDM due to its effectiveness, user convenience, affordability and ease of storage. The ease with the use of this oral drug can also be stretched to the remotest areas with poor literacy and storage challenges. These features make it appropriate for our environment and appealing to both patients and physicians. Metformin has been postulated to induce less gluconeogenesis, increase peripheral glucose uptake and increase insulin sensitivity. Although it crosses the placenta, recent evidence supports its safety in pregnancy. Aim The aim of this study is to compare the effectiveness of insulin with metformin in the management of gestational diabetes mellitus at the department of Obstetrics and Gynaecology, University of Abuja Teaching Hospital, Abuja.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Gestational Diabetes Mellitus
Purpose of the trial Treatment: Drugs
Anticipated trial start date 20/10/2023
Actual trial start date 20/10/2023
Anticipated date of last follow up 20/04/2024
Actual Last follow-up date 20/04/2024
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Not yet 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 Dynamic (adaptive) random allocation such as minimization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Subcute insulin Subcute insulin dosage will be based on weight and gestational age 4-8 weeks Participants will be recruited at between 24-28 weeks gestation and commenced on diet and exercise for 2 weeks. Participants will then be randomized based on failure of above therapy. Subcute insulin will be administered to the control group. Dosage will be gotten from their calculated weight and gestational age. 2/3rd of this will be given in the morning. half of the remaining 1/3rd will be given in the afternoon and the remaining half given in tthe night. a particular time in the morning afaternoon and night will be chosen for this. 30 Active-Treatment of Control Group
Experimental Group Metformin 500mg daily. dosage to be increased base on blood sugar measurement but not more than 3000mg daily at divided doses 4-8 weeks patients will be recruited at between 24-28 weeks gestation and commenced on diet and exercise for 2 weeks. patients will then be randomized based on failure of above therapy. oral metformin will be administered to the experimental group at initial dose of 500mg daily. Thereafter dosage will be increase base on blood sugar measurement but not more than 3000mg daily in divided doses 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Booked ante natal care patients Diagnosed for the first time with GDM Gestational age of 24-28weeks Gave consent 1. Type 1 and type 2 diabetes 2. Any pregnant woman who was already on insulin or metformin treatment. 3. Maternal hypersensitivity or intolerance to metformin, 4. Mothers with a congenitally malformed fetus 5. Liver diseases 6. kidney diseases 7. severe cardiac 8. neurologic disease 9. Any obstetric high risk condition(s) Adult: 19 Year-44 Year 19 Year(s) 44 Year(s) Female
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 19/09/2023 University of Abuja Teaching Hospital Health Research Ethics Committee UATH HREC
Ethics Committee Address
Street address City Postal code Country
University of Abuja Teaching Hospital Abuja 902101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome maternal glycaemic control in terms of the fasting blood sugar and random blood sugar control fasting blood sugar and 2 hours post priadrial blood sugar
Secondary Outcome Secondary outcome Neonatal Random blood sugar at birth at birth
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Abuja Teaching Hospital Abuja Nigeria University of Abuja Teaching Hospital along Passo Road, Gwagwalada, Abuja Nigeria Abuja 902101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Abah Innocent Ochigbo No 5, Passo Road, Gwagwalada, Abuja Nigeria Abuja 902101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Abah Innocent Ochigbo No 5, Passo Road, Gwagwalada, Abuja Nigeria Abuja 902101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator INNOCENT ABAH OCHIGBO innoabaho@gmail.com +2348037537336 No 5 Passo Road, Gwagwalada
City Postal code Country Position/Affiliation
Abuja 902101 Nigeria Resident Doctor
Role Name Email Phone Street address
Public Enquiries NATHANIEL ADEWOLE nadewole2013@gmail.com +2348038039182 No 7, Dukpa Road, Gwagwalada
City Postal code Country Position/Affiliation
Abuja 902101 Nigeria HOD Obstetrics and Gynaecology Department University of Abuja Teaching Hospital Abuja
Role Name Email Phone Street address
Scientific Enquiries DENNIS ISAH denisanthonyisah@yahoo.com +2348061109664 Doctors quarters, Dukpa Estate, Gwagwalada
City Postal code Country Position/Affiliation
Abuja 902101 Nigeria PostGraduate Cordinator University of Abuja Teaching Hospital Abuja
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Plan to Share IPD: “Yes” Plan Description: “Data obtained through this study may be provided to qualified researchers with academic interest in gestational diabetes mellitus, insulin and metformin. Data or samples shared will be coded. 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. Time Frame: “Data requests can be submitted starting 1 year after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.” Access Criteria: ““Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 1 year gestational diabestes mellitus, metformin, insulin
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