Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06319560
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-01-23
Brief Title:
Hydroxychloroquine in Type 2 Diabetes During Pregnancy
Sponsor:
National University of Malaysia
Organization:
National University of Malaysia
Study Overview
Official Title:
Improvement in Glucose Control With Hydroxychloroquine in Type 2 Diabetes During Pregnancy A Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to compare the use of hydroxychloroquine as an adjunct to the current treatment of pregnant women with Type 2 diabetes mellitus
The main questions it aims to answer are
Does hydroxychloroquine improve the pregnancy outcomes in women with type 2 diabetes during pregnancy
Does hydroxychloroquine improve the inflammatory markers in women with type 2 diabetes during pregnancy Participants will be randomised into the intervention and control group The control group will be on standard treatment where as the intervention group will receive hydroxychloroquine as an adjunct of standard treatment
The main questions it aims to answer are
Does hydroxychloroquine improve the pregnancy outcomes in women with type 2 diabetes during pregnancy
Does hydroxychloroquine improve the inflammatory markers in women with type 2 diabetes during pregnancy Participants will be randomised into the intervention and control group The control group will be on standard treatment where as the intervention group will receive hydroxychloroquine as an adjunct of standard treatment
Detailed Description:
This is a randomised clinical trial comparing 2 groups ie type 2 diabetes complicating pregnancies on standard treatment alone which comprises of oral hypoglycaemic agent with or without insulin and those with added hydroxychloroquine 200mg daily They will be recruited within 14-20 weeks gestation Randomisation will be done using computer software program At recruitment blood is withdrawn to measure glycated haemoglobin fructosamine Interleukin-6 Interleukin-10 and Tumour Necrosis Factor-alpha These investigations will be repeated before delivery Patients will monitor their blood glucose using staggered 7 points which consist of fasting pre-lunch and dinner 1 hour post breakfast lunch and dinner and pre bed using their own glucometer The optimum fasting level is 4-53 mmoll pre meal and pre bed levels of 4-6 mmoll and 1 hour post meal level of 4-78 mmoll All participants are followed up every 2-4 weekly whereby home blood glucose monitoring will be reviewed Fetal growth will be monitored via serial ultrasound and charted on the fetal growth chart Patients care will be done by the research team which consist of obstetrician endocrinologist and diabetic educator All patients will have eye assessment by the ophthalmologist prior to commencement of hydroxychloroquine Placental shear wave elastography will be performed within 32-36 weeks of gestation using ultrasound and the results are documented
All women will be delivered at 38 weeks or earlier if there are other concomitant problems such fetal growth restriction or poorly controlled diabetes via induction of labour The details of the delivery for both mother and neonates will be documented At birth the offsprings will be seen by the neonatologist who is also in the research team After delivery participants will be followed up in research clinic at 6 and 12 months together with the neonate The height and weight of the infants will be measured in centimeter Developmental milestones will be assessed according to the developmental milestones chart of Paediatric Protocols for Malaysian Hospitals 4th Edition 2019
Compliance to hydroxychloroquine will be assessed at each follow up whereby an indirect method of assessing adherence of participants in the hydroxychloroquine group will be made Each participant will be asked whether they are still taking the study medication and are required to bring the remaining medication for tablet count Participants with remaining of more than 20 of the scheduled medications will be considered as non-compliance and treated as drop-out Participants will also be considered as drop-out when they are lost to follow-up withdrawal of consent non-compliance to hydroxychloroquine or a patient becomes ill due to drug adverse effects
All women will be delivered at 38 weeks or earlier if there are other concomitant problems such fetal growth restriction or poorly controlled diabetes via induction of labour The details of the delivery for both mother and neonates will be documented At birth the offsprings will be seen by the neonatologist who is also in the research team After delivery participants will be followed up in research clinic at 6 and 12 months together with the neonate The height and weight of the infants will be measured in centimeter Developmental milestones will be assessed according to the developmental milestones chart of Paediatric Protocols for Malaysian Hospitals 4th Edition 2019
Compliance to hydroxychloroquine will be assessed at each follow up whereby an indirect method of assessing adherence of participants in the hydroxychloroquine group will be made Each participant will be asked whether they are still taking the study medication and are required to bring the remaining medication for tablet count Participants with remaining of more than 20 of the scheduled medications will be considered as non-compliance and treated as drop-out Participants will also be considered as drop-out when they are lost to follow-up withdrawal of consent non-compliance to hydroxychloroquine or a patient becomes ill due to drug adverse effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None