Gestational Diabetes MellitusMYPPNCT05524259
MYPP-trial: Myo-inositol Supplementation to Prevent Pregnancy Complications in Women With Polycystic Ovary Syndrome.
A study testing Myo-inositol and routinely recommended folic acid and Routinely recommended folic acid in people with Gestational Diabetes Mellitus and Preeclampsia, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Polycystic Ovary Syndrome (PCOS) is the most common endocrine disorder in women of reproductive age. PCOS is a heterogeneous condition, characterised by metabolic disturbances, insulin resistance and hyperandrogenism. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes Mellitus, Preeclampsia, Preterm Birth
- What is being tested?
- Myo-inositol and routinely recommended folic acid and Routinely recommended folic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 464 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Jun 2019to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- Diagnosis of PCOS according to the Rotterdam consensus criteria and confirmed by a gynaecologist
- A viable singleton pregnancy confirmed by ultrasound
- Being able to initiate the use of study supplements between 8+0 and 16+0 weeks gestational age
- Ability to understand Dutch or English
- Ability to provide written informed consent
Who cannot join
- Diagnosis of pre-existent type-1 or 2 diabetes mellitus
- Pre-existent renal failure, defined as an estimated glomerular filtration rate (eGFR) less than 50 ml/min/1.73m2
- Use of myo-inositol supplements, other insulin-mimetics, hypoglycaemic agents (e.g. metformin) and/or systemic steroids, that cannot be discontinued at the time of inclusion
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus University Medical Center
Rotterdam, South Holland, 3015 GD
Rebekka Bout - Rebel, MSc, 31612437377, r.bout-rebel@erasmusmc.nl
About this study
Official title: MYPP-trial: Myo-inositol Supplementation to Prevent Pregnancy Complications in Women With Polycystic Ovary Syndrome: a Multicentre Double-blind Randomised Controlled Trial
Polycystic Ovary Syndrome (PCOS) is the most common endocrine disorder in women of reproductive age. PCOS is a heterogeneous condition, characterised by metabolic disturbances, insulin resistance and hyperandrogenism. Pregnancies in women with PCOS have an increased risk of gestational diabetes mellitus, preeclampsia and preterm birth, and their offspring have an increased risk of aberrant birth weight and hospitalization. After pregnancy, PCOS is thought to have an impact on breastfeeding success and breastmilk composition.
Current strategies to improve pregnancy outcome among women with PCOS have not demonstrated significant risk reduction. Myo-inositol is a commonly used dietary supplement with a favourable effect on glucose metabolism and insulin sensitivity. Optimal intake of myo-inositol is associated with a decrease in glucose, lower insulin and lower testosterone levels in women with PCOS. Among women with PCOS-related disorders (e.g. in women with obesity), myo-inositol supplementation in pregnancy has been shown to have clinical benefits in preventing adverse pregnancy outcomes in a number of clinical trials, by reducing the risk of gestational diabetes mellitus, hypertensive complications and preterm birth.
Read more
The MYPP-trial will be the first randomised prospective trial aimed specifically at pregnant women with PCOS, to evaluate the potential effectiveness of myo-inositol supplementation as a nutritional intervention to prevent all three pregnancy complications associated with PCOS (i.e. GDM, preeclampsia and preterm birth). Secondary objectives are to evaluate the impact of supplementation on maternal (mental) and neonatal health, breastfeeding practices and breastmilk composition. In addition, a full cost-effectiveness analysis will be performed.
Women with a diagnosis of PCOS and a singleton pregnancy between 8+0 and 16+0 weeks of gestational age are eligible. Participants randomly allocated to the intervention group will receive 4 grams myo-inositol added to their routinely recommended folic acid supplement, divided over two daily sachets of sugary powder throughout pregnancy. The control group will receive similar looking sachets of supplements containing only the standard dose of folic acid without the added myo-inositol supplement, as part of the current standard-of-care recommendation. In addition to receiving supplements, participants will be asked to complete three questionnaires, provide blood and urine samples once each trimester of pregnancy, and routine ultrasound scanning will be performed to assess fetal growth. All study visits will be aligned with routine antenatal care appointments. Additionally, subjects can choose to participate in research on the impact of myo-inositol supplementation on breastfeeding and take part in the MYPP biobank.
The results of this study will provide important novel recommendations for PCOS patients on the importance of optimising life-style and nutrient intake to improve pregnancy outcome.
- Being tested
- Myo-inositol and routinely recommended folic acid, Routinely recommended folic acid
- Medical subject headings
- Diabetes, Gestational, Pre-Eclampsia, Premature Birth, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myo-inositol and routinely recommended folic acidDietary supplement
Participants randomly allocated to the intervention group will receive 4 grams myo-inositol added to their routinely recommended 0.4 mg folic acid supplement, divided over two daily sachets of sugary powder throughout pregnancy.
Routinely recommended folic acidDietary supplement
The control group will receive similar looking sachets of supplements containing only the standard dose of 0.4 mg folic acid without the added myo-inositol supplement as part of the current standard-of-care recommendation.
| Study group | Role | What they receive |
|---|---|---|
| Myo-inositol and routinely recommended folic acid | Active comparator | Myo-inositol is a naturally occurring substance, with a structure quite similar to glucose, which forms an essential component of the cell membrane and is known to support several cellular processes in all living organisms. It is present in nature in high abundance and can be found in many food products. Myo-inositol was historically considered part of the vitamin-B complex and can safely be used as a dietary supplement. In humans, it is synthesized de novo from glucose-6-phosphate in many tissues, mainly in the kidney. Under normal circumstances, the kidneys produce large quantities of myo-inositol, estimated at about 4 grams of endogenous production per day. Myo-inositol has been shown to have a physiological role in supporting the effects of insulin in all living beings. It fulfils a second messenger role in the insulin signalling pathway by enhancing the translocation of GLUT-4 receptors on the plasma membrane and thereby facilitates the intra-cellular uptake of glucose. Receives: Dietary Supplement: Myo-inositol and routinely recommended folic acid |
| Routinely recommended folic acid | Placebo comparator | Folic acid supplements are part of routine pregnancy care and frequently used as background supplements in previous trials on myo-inositol supplementation in pregnancy. Receives: Dietary Supplement: Routinely recommended folic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of PCOS patients in the two study arms that develop Gestational Diabetes Mellitus (GMD).
GDM is defined as any degree of glucose intolerance with onset or first recognition during pregnancy.
Measured: Measured from 12 weeks up to 28 weeks gestational age using an Oral Glucose Tolerance Test (OGTT)
The incidence of PCOS patients in the two study arms that develop preeclampsia.
Preeclampsia as defined by the International Society for the Study of Hypertension in Pregnancy (ISSHP).
Measured: Measured from 20 weeks gestational age up to one week post-partum.
The incidence of PCOS patients in the two study arm that give birth before 37 completed weeks of gestational age.
Preterm birth is internationally defined as any birth before 37 completed weeks of gestational age.
Measured: At delivery
Secondary outcomes (3)
Maternal mental health assessed by Beck Depression Inventory (BDI) Scale II Netherlands.
The BDI-II-NL measures characteristic attitudes and symptoms of depression and contains 21 items, subdivided in cognitive, affective and somatic factors. Patients rate themselves on these depressive symptoms by endorsing the most relevant statement (ranging in four steps of intensity from minimal to severe) covering a time frame of the past 2 weeks.
Measured: Measured at study inclusion, 36 weeks of pregnancy and 6 weeks postpartum.
Maternal Health Related Quality of Life assessed by 5-Level EuroQol - five dimension (EQ-5D-5L) and Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ)
he EQ-5D-5L records the patient's self-rated health, and a descriptive system. The descriptive system distinguishes five health domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The PCOSQ is the only existing validated, disease-specific, health related quality of life assessment questionnaire. As stated in the new evidence-based PCOS guidelines, this questionnaire could be clinically useful to highlight PCOS features causing greatest distress and was developed to evaluate the effect of treatment in clinical trials in PCOS.
Measured: Measured at study inclusion, 36 weeks of pregnancy and 6 weeks postpartum.
The incidence of neonatal outcomes in the two study arms (e.g. incidence of neonatal intensive care unit (NICU) admissions, incidence of Neonatal hypoglycaemia).
- The incidence of Small-for-gestational-age (SGA): babies in the two study arms; birth weight ≤10th percentile or two standard deviations below the mean birth weight for gestational age, using Dutch Perinatal Registry birth weight reference charts.
- The incidence of Large-for-gestational-age (LGA) babies in the two study arms: birth weight ≥90th percentile for gestational age, using Dutch Perinatal Registry birth weight reference charts.
- The incidence of NICU admission in the two study arms, including reason for admission and time to discharge or transfer to another unit.
- The incidence of Neonatal hypoglycaemia in the two study arms:
Measured: Measured form birth and ultimately scored up until six weeks postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start21 Jun 2019
- Primary completionSep 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 464 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, B.B. van Rijn, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524259
- Sponsor's protocol ID
- MEC-2019-0005, NL67329.078.18
- Acronym
- MYPP
- Status last verified
- Aug 2022
- First submitted
- 27 Jul 2022
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MYPP-trial: Myo-inositol Supplementation to Prevent Pregnancy Complications in Women With Polycystic Ovary Syndrome: a Multicentre Double-blind Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05524259
- Acronym / sponsor ID
- MYPP / MEC-2019-0005, NL67329.078.18
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 464 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 21 Jun 2019 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 1 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Polycystic Ovary Syndrome (PCOS) is the most common endocrine disorder in women of reproductive age. PCOS is a heterogeneous condition, characterised by metabolic disturbances, insulin resistance and hyperandrogenism. Pregnancies in women with PCOS have an increased risk of gestational diabetes mellitus, preeclampsia and preterm birth, and their offspring have an increased risk of aberrant birth weight and hospitalization. After pregnancy, PCOS is thought to have an impact on breastfeeding success and breastmilk composition.
Current strategies to improve pregnancy outcome among women with PCOS have not demonstrated significant risk reduction. Myo-inositol is a commonly used dietary supplement with a favourable effect on glucose metabolism and insulin sensitivity. Optimal intake of myo-inositol is associated with a decrease in glucose, lower insulin and lower testosterone levels in women with PCOS. Among women with PCOS-related disorders (e.g. in women with obesity), myo-inositol supplementation in pregnancy has been shown to have clinical benefits in preventing adverse pregnancy outcomes in a number of clinical trials, by reducing the risk of gestational diabetes mellitus, hypertensive complications and preterm birth.
The MYPP-trial will be the first randomised prospective trial aimed specifically at pregnant women with PCOS, to evaluate the potential effectiveness of myo-inositol supplementation as a nutritional intervention to prevent all three pregnancy complications associated with PCOS (i.e. GDM, preeclampsia and preterm birth). Secondary objectives are to evaluate the impact of supplementation on maternal (mental) and neonatal health, breastfeeding practices and breastmilk composition. In addition, a full cost-effectiveness analysis will be performed.
Women with a diagnosis of PCOS and a singleton pregnancy between 8+0 and 16+0 weeks of gestational age are eligible. Participants randomly allocated to the intervention group will receive 4 grams myo-inositol added to their routinely recommended folic acid supplement, divided over two daily sachets of sugary powder throughout pregnancy. The control group will receive similar looking sachets of supplements containing only the standard dose of folic acid without the added myo-inositol supplement, as part of the current standard-of-care recommendation. In addition to receiving supplements, participants will be asked to complete three questionnaires, provide blood and urine samples once each trimester of pregnancy, and routine ultrasound scanning will be performed to assess fetal growth. All study visits will be aligned with routine antenatal care appointments. Additionally, subjects can choose to participate in research on the impact of myo-inositol supplementation on breastfeeding and take part in the MYPP biobank.
The results of this study will provide important novel recommendations for PCOS patients on the importance of optimising life-style and nutrient intake to improve pregnancy outcome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myo-inositol and routinely recommended folic acid | Active comparator | Dietary Supplement: Myo-inositol and routinely recommended folic acidMyo-inositol is a naturally occurring substance, with a structure quite similar to glucose, which forms an essential component of the cell membrane and is known to support several cellular processes in all living organisms. It is present in nature in high abundance and can be found in many food products. Myo-inositol was historically considered part of the vitamin-B complex and can safely be used as a dietary supplement. In humans, it is synthesized de novo from glucose-6-phosphate in many tissues, mainly in the kidney. Under normal circumstances, the kidneys produce large quantities of myo-inositol, estimated at about 4 grams of endogenous production per day. Myo-inositol has been shown to have a physiological role in supporting the effects of insulin in all living beings. It fulfils a second messenger role in the insulin signalling pathway by enhancing the translocation of GLUT-4 receptors on the plasma membrane and thereby facilitates the intra-cellular uptake of glucose. |
| Routinely recommended folic acid | Placebo comparator | Dietary Supplement: Routinely recommended folic acidFolic acid supplements are part of routine pregnancy care and frequently used as background supplements in previous trials on myo-inositol supplementation in pregnancy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 18 years of age
- Diagnosis of PCOS according to the Rotterdam consensus criteria and confirmed by a gynaecologist
- A viable singleton pregnancy confirmed by ultrasound
- Being able to initiate the use of study supplements between 8+0 and 16+0 weeks gestational age
- Ability to understand Dutch or English
Key exclusion criteria (3 listed)
- Diagnosis of pre-existent type-1 or 2 diabetes mellitus
- Pre-existent renal failure, defined as an estimated glomerular filtration rate (eGFR) less than 50 ml/min/1.73m2
- Use of myo-inositol supplements, other insulin-mimetics, hypoglycaemic agents (e.g. metformin) and/or systemic steroids, that cannot be discontinued at the time of inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myo-inositol and routinely recommended folic acidParticipants randomly allocated to the intervention group will receive 4 grams myo-inositol added to their routinely recommended 0.4 mg folic acid supplement, divided over two daily sachets of sugary powder throughout pregnancy. | Dietary supplement | Myo-inositol and routinely recommended folic acid |
| Routinely recommended folic acidThe control group will receive similar looking sachets of supplements containing only the standard dose of 0.4 mg folic acid without the added myo-inositol supplement as part of the current standard-of-care recommendation. | Dietary supplement | Routinely recommended folic acid |
Primary outcome
The incidence of PCOS patients in the two study arms that develop Gestational Diabetes Mellitus (GMD).
Time frame: Measured from 12 weeks up to 28 weeks gestational age using an Oral Glucose Tolerance Test (OGTT)
GDM is defined as any degree of glucose intolerance with onset or first recognition during pregnancy.
The incidence of PCOS patients in the two study arms that develop preeclampsia.
Time frame: Measured from 20 weeks gestational age up to one week post-partum.
Preeclampsia as defined by the International Society for the Study of Hypertension in Pregnancy (ISSHP).
The incidence of PCOS patients in the two study arm that give birth before 37 completed weeks of gestational age.
Time frame: At delivery
Preterm birth is internationally defined as any birth before 37 completed weeks of gestational age.
3 secondary outcomes
Maternal mental health assessed by Beck Depression Inventory (BDI) Scale II Netherlands.
Time frame: Measured at study inclusion, 36 weeks of pregnancy and 6 weeks postpartum.
Maternal Health Related Quality of Life assessed by 5-Level EuroQol - five dimension (EQ-5D-5L) and Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ)
Time frame: Measured at study inclusion, 36 weeks of pregnancy and 6 weeks postpartum.
The incidence of neonatal outcomes in the two study arms (e.g. incidence of neonatal intensive care unit (NICU) admissions, incidence of Neonatal hypoglycaemia).
Time frame: Measured form birth and ultimately scored up until six weeks postpartum.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myo-inositol and routinely recommended folic acid and Routinely recommended folic acid in people with Gestational Diabetes Mellitus and Preeclampsia, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rebekka Bout - Rebel, MSc (31612437377, r.bout-rebel@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of PCOS patients in the two study arms that develop Gestational Diabetes Mellitus (GMD). (time frame: Measured from 12 weeks up to 28 weeks gestational age using an Oral Glucose Tolerance Test (OGTT)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.