Active not recruitingPHASE4INTERVENTIONAL

Ursodeoxycholic Acid vs Metformin in Gestational Diabetes Mellitus

Around 35,000 women in the UK get diabetes during pregnancy (gestational diabetes) each year. While Metformin is often used, there are concerns about how well it works and its safety. This study, called GUARD, is looking for a new treatment. We are comparing Ursodeoxycholic Acid (UDCA), a medicine sometimes used in pregnancy for other conditions, with Metformin. We want to see which medicine is more effective at controlling blood sugar levels. We'll be recruiting 158 pregnant women who are overweight or obese and need medicine for their gestational diabetes. We'll ask them to wear a monitor and answer some questions, with visits matching their usual antenatal appointments.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

King's College London

Enrolment target

Start

01 Jul 2021

Estimated completion

31 May 2025

Gestational Diabetes

What is this study about?

This study is about a type of diabetes that can develop during pregnancy, called gestational diabetes. It affects many women each year in the UK and can cause problems for both mum and baby. Often, doctors prescribe a medicine called Metformin to help control blood sugar levels. However, we're not always sure how effective Metformin is for all women, and there are some questions about its side effects during pregnancy. This means there's a real need to find other safe and effective treatments.

That's where this study comes in. We're looking at a different medicine called Ursodeoxycholic Acid, or UDCA for short. UDCA is already sometimes used during pregnancy for another condition, so we know it can be safe. Some early information suggests that UDCA might also help control blood sugar in women with gestational diabetes. Right now, it's not a standard treatment for gestational diabetes, so we need to do this study to find out if it works.

The main goal of this study is to see if UDCA is as good as, or even better than, Metformin at controlling blood sugar levels in pregnant women with gestational diabetes. We hope our findings will help us offer better treatment options to women in the future, improving health for both mothers and their babies.

Key takeaways

This study compares two medicines for gestational diabetes: Metformin and Ursodeoxycholic Acid.
It aims to find a more effective and potentially safer treatment option.
You would take one of the medicines as tablets twice a day.
Participation involves three study visits, mostly matching your antenatal appointments, and wearing a blood sugar monitor at times.
The study is looking for around 158 overweight or obese women with gestational diabetes who need medication.
You can stop participating at any time without affecting your medical care.

Who may be eligible?

This study is looking for pregnant women who are between 16 and 45 years old. You would need to have been diagnosed with gestational diabetes between 26 and 30 weeks of pregnancy according to UK guidelines, and your doctor believes you need medication to manage it. You also need to be overweight or obese (with a BMI of 25 or higher before pregnancy) and planning to have all your antenatal, birth, and after-birth care at one of the study hospitals.

There are some reasons why you wouldn't be able to join. For instance, if you're having twins or more babies, if you've had diabetes before pregnancy, or if you have certain other serious health conditions. We also can't include you if you're already in another study that might affect your gestational diabetes results, or if you have a known allergy to the study medications. You'll also need to be able to understand the study information and give your consent, or have an interpreter available if English isn't your first language.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 16 and 45 years old?
Have you been diagnosed with gestational diabetes between 26 and 30 weeks of pregnancy?
Do you need medication for your gestational diabetes?
Were you overweight or obese before pregnancy (BMI 25 or more)?
Are you planning to have all your maternity care at one of the study hospitals?
Are you only pregnant with one baby (not twins or more)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to receive either Ursodeoxycholic Acid or Metformin, both taken as tablets twice a day. You will have three study visits, which we will try to arrange at the same time as your routine antenatal appointments to make it easier for you. At these visits, we will collect some blood samples for various tests and ask you to complete two questionnaires about your quality of life and how satisfied you are with your treatment.

You will also be asked to wear a continuous glucose monitor for three separate 10-day periods during the study. This small device sticks to your skin and automatically tracks your blood sugar levels. There will also be some optional additional tests you might be offered. The study will mainly look at your fasting blood sugar level when you are 36 weeks pregnant. You will continue to be followed up until after your baby is born, though the exact duration isn't specified, it aligns with your standard care.

Potential risks and benefits

Taking part in this study could offer you the benefit of close monitoring of your gestational diabetes and access to a potentially new and effective treatment. While both medicines we are studying are generally considered safe, like all medications, they can have side effects. Metformin can cause tummy upsets, and while UDCA is commonly used in pregnancy, we are still studying its effects on gestational diabetes. Some blood tests will be taken, which might cause minor discomfort. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Guy's and St Thomas' NHS Foundation Trust
Verified postcode
London, United Kingdom

Common questions

What is gestational diabetes?

It's a type of diabetes that develops during pregnancy and usually goes away after the baby is born. It means your body can't make enough insulin to keep your blood sugar levels normal during pregnancy.

Why is this study being done?

We want to find new and better ways to treat gestational diabetes, as current treatments like Metformin don't work for everyone, and there are some questions about their use during pregnancy.

What is Ursodeoxycholic Acid (UDCA)?

UDCA is a medicine already used in pregnancy for a different liver condition. Early evidence suggests it might also help control blood sugar in women with gestational diabetes, and this study aims to find out for sure.

Will I know which medicine I'm taking?

Yes, this study is 'open label,' meaning both you and your doctors will know whether you are taking Ursodeoxycholic Acid or Metformin.

Where is the study taking place?

The study is taking place at three hospitals in the UK: Guy's and St Thomas', Imperial College, and Nottingham.