Hydroxychloroquine in Type 2 Diabetes During Pregnancy

Type 2 Diabetes Clinical Trial

Official title:

Improvement in Glucose Control With Hydroxychloroquine in Type 2 Diabetes During Pregnancy: A Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06319560
• Other study ID #: JEP-2023-866
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2024
• Est. completion date: January 1, 2027

Study information

• Verified date: April 2024
• Source: National University of Malaysia
• Contact: Rahana Abdul Rahman, MD
• Phone: 039145
• Email: drrahana[@]ukm.edu.my
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

This is a randomised clinical trial comparing 2 groups i.e 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 At recruitment, blood is withdrawn to measure glycated haemoglobin, fructosamine, Interleukin-6, Interleukin-10 and Tumour Necrosis Factor-alpha.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 4-5.3 mmol/l, pre meal and pre bed levels of 4-6 mmol/l and 1 hour post meal level of 4-7.8 mmol/l. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Singleton
• Pregnant women with a confirmed diagnosis of type 2 Diabetes Mellitus

Exclusion Criteria:

• autoimmune disease such as Systemic Lupus Erythematosus or rheumatic disease
• chronic kidney disease
• fetal anomaly
• Women on steroid therapy
• Diabetic retinopathy

Related Conditions & MeSH terms

• Diabetes in Pregnancy
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes, Gestational
• Pregnancy in Diabetics
• Type 2 Diabetes

Intervention

Drug:
• Hydroxychloroquine Oral Tablet
200mg daily

Locations

Country	Name	City	State
Malaysia	Antenatal clinic, UKM Medical Centre	Cheras	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the serum glycated haemoglobin between the two groups	Serum level of glycated haemoglobin in percentage	From Day 1 up to 38 weeks of gestation
Primary	To compare the serum fructosamine between the two groups	Serum level of fructosamine in nanogram per milliliter	From Day 1 up to 38 weeks of gestation
Primary	To compare the serum interleukin-6 between the two groups	Serum level of interleukin-6 in nanogram per milliliter	From Day 1 up to 38 weeks of gestation
Primary	To compare the serum interleukin-10 between the two groups	Serum level of interleukin-10 in nanogram per milliliter	From Day 1 up to 38 weeks of gestation
Primary	To compare the serum tumour necrosis factor alpha between the two groups	Serum level of tumour necrosis factor alpha in nanogram per milliliter	From Day 1 up to 38 weeks of gestation
Primary	To compare the shearwave elastography of the placenta between the two groups	Ultrasonography of shearwave of placenta measured in centimetres	From 32 until 36 weeks of gestation
Secondary	To compare the gestational age at delivery between the two groups	Gestational age at delivery in weeks	From recruitment up to 38 weeks of gestation
Secondary	Type of labour	Onset of labour either spontaneous or induced	From Day 1 up to 38 weeks of gestation
Secondary	Mode of delivery	Method of patient being delivered either vaginal or caesarean section	From Day 1 up to 38 weeks of gestation
Secondary	Postpartum haemorrhage	Total blood loss of more than 500 milliliters for vaginal delivery and 1000 milliliters for caesarean delivery	At delivery from Day 1 up to 38 weeks of gestation
Secondary	Third or fourth degree perineal tear	The number of patients of suffered third or fourth degree perineal tear	At delivery from Day 1 up to 38 weeks of gestation
Secondary	Neonatal birth weight at delivery	Birth weight of the neonate in grams	At delivery from Day 1 up to 38 weeks of gestation
Secondary	Large for gestational age or macrosomia	Neonatal birth weight of more than 95th percentile based on Fenton birth weight chart or 4000 grams	At delivery from Day 1 up to 38 weeks of gestation
Secondary	Shoulder dystocia	Number of patient who experienced shoulder dystocia at delivery	At delivery from Day 1 up to 38 weeks of gestation
Secondary	Appearance, pulse, grimace, activity and respiration score of neonate at 5 minutes	Number of neonates with Apgar score of less than 7 at birth which is bad outcome	At delivery from Day 1 up to 38 weeks of gestation
Secondary	Arterial cord pH at birth	Number of neonates with arterial cord pH less than 7.25 at birth	At delivery from Day 1 up to 38 weeks of gestation
Secondary	Number of neonates needing admission into neonatal intensive care unit	Admission of neonate into neonatal intensive care unit at birth	At delivery up to 7 days of life from Day 1 up to 38 weeks of gestation
Secondary	Height or length of neonates	Height or length of the neonates measured in centimetres	At six and twelve months of age after delivery
Secondary	Weight of the neonates	Weight of the neonates measured in grams	At six and twelve months of age after delivery
Secondary	Hospital admission	Numbers of neonates required hospital admission	From birth up to twelve months of age