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Pregnancy RelatedNCT06575868

Myo-inositol During Pregnancy to Prevent Gestational Diabetes

A study testing Myo-inositol in people with Pregnancy Related, run by Tufts Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Myoinositol is an insulin-like compound that is present in both plant and animal cells. Humans synthesize it naturally, but it is also obtained in our diet. It works through an intracellular signaling pathway to increase insulin sensitivity. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Pregnancy Related
What is being tested?
Myo-inositol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
1 Mar 2025to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Singleton gestations
  • Women aged > 18 years and < 45 years
  • Recruited before 16 weeks gestation
  • Obese (pre-pregnancy BMI ≥ 30)
  • Receiving prenatal care at Tufts Medical Center
  • Planning to give birth at Tufts Medical Center
Show all 9Show fewer
  • Can tolerate glucose tolerance test
  • Willing and able to wear CGM
  • Willing and able to sign informed consent

Who cannot join

  • Multiple gestation
  • Preexisting diabetes
  • Taking medications that impact body weight or metabolism (eg metformin)
  • Inability to tolerate glucose tolerance test
  • Adults unable to consent (cognitively impaired adults)
  • Wards of the state
  • Non-viable neonates
  • Neonates of uncertain viability

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zeinab Kassem, MD contact

617-636-9897

zeinab.kassem@tuftsmedicine.org

United States1 site, 1 recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Zeunab Kassem, 617-636-9897, zeinab.kassem@tuftsmedicalcenter.org

    Recruiting

Other trials in United States

About this study

Official title: Continuous Glucose Monitoring in Myo-inositol Supplemented Obese Pregnant Individuals: a Feasibility Pilot Randomized Control Trial

Myoinositol is an insulin-like compound that is present in both plant and animal cells. Humans synthesize it naturally, but it is also obtained in our diet. It works through an intracellular signaling pathway to increase insulin sensitivity. Myoinositol has been used as an over-the-counter (OTC) supplement in the management of polycystic ovarian syndrome due to this effect. Myoinositol has also been shown to improve glycemic profiles in pregnant euglycemic women and well as improve insulin sensitivity in pregnant patients with gestational diabetes mellitus (GDM).

This is a double blind RCT offering myo-inositol or placebo to those who are eligible and enrolled.

Being tested
Myo-inositol, Myo-inositol placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Myo-inositolDietary supplement

    Patients would begin taking myoinositol upon recruitment

  • Myo-inositol placeboDietary supplement

    Patients would begin taking placebo upon recruitment

Study groups in NCT06575868
Study groupRoleWhat they receive
Myo-inositolExperimentalNot described
Receives: Dietary Supplement: Myo-inositol
Placebo myo-inositolPlacebo comparatorNot described
Receives: Dietary Supplement: Myo-inositol placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Eligibility

    proportion of screened women who were eligible

    Measured: 1 year

  2. Glucose levels

    Average glucose levels during CGM monitoring period for those enrolled

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2024
  2. Study start1 Mar 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06575868
Sponsor's protocol ID
STUDY00005304
Status last verified
Apr 2025
First submitted
26 Aug 2024
Last updated
29 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Muller G, Wied S, Crecelius A, Kessler A, Eckel J. Phosphoinositolglycan-peptides from yeast potently induce metabolic insulin actions in isolated rat adipocytes, cardiomyocytes, and diaphragms. Endocrinology. 1997 Aug;138(8):3459-75. doi: 10.1210/endo.138.8.5308.

    PubMed 9231801

  • Croze ML, Soulage CO. Potential role and therapeutic interests of myo-inositol in metabolic diseases. Biochimie. 2013 Oct;95(10):1811-27. doi: 10.1016/j.biochi.2013.05.011. Epub 2013 Jun 10.

    PubMed 23764390

  • Artini PG, Di Berardino OM, Papini F, Genazzani AD, Simi G, Ruggiero M, Cela V. Endocrine and clinical effects of myo-inositol administration in polycystic ovary syndrome. A randomized study. Gynecol Endocrinol. 2013 Apr;29(4):375-9. doi: 10.3109/09513590.2012.743020. Epub 2013 Jan 22.

    PubMed 23336594

  • Scioscia M, Kunjara S, Gumaa K, Gomez Galan AM, McLean P, Rodeck CH, Rademacher TW. Altered urinary release of inositol phosphoglycan A-type in women with gestational diabetes mellitus. Gynecol Obstet Invest. 2007;64(4):217-23. doi: 10.1159/000106494. Epub 2007 Jul 30.

    PubMed 17664885

  • Malvasi A, Casciaro F, Minervini MM, Kosmas I, Mynbaev OA, Pacella E, Monti Condesnitt V, Creanza A, Di Renzo GC, Tinelli A. Myo-inositol, D-chiro-inositol, folic acid and manganese in second trimester of pregnancy: a preliminary investigation. Eur Rev Med Pharmacol Sci. 2014;18(2):270-4.

    PubMed 24488919

  • Corrado F, D'Anna R, Di Vieste G, Giordano D, Pintaudi B, Santamaria A, Di Benedetto A. The effect of myoinositol supplementation on insulin resistance in patients with gestational diabetes. Diabet Med. 2011 Aug;28(8):972-5. doi: 10.1111/j.1464-5491.2011.03284.x.

    PubMed 21414183

  • D'Anna R, Di Benedetto A, Scilipoti A, Santamaria A, Interdonato ML, Petrella E, Neri I, Pintaudi B, Corrado F, Facchinetti F. Myo-inositol Supplementation for Prevention of Gestational Diabetes in Obese Pregnant Women: A Randomized Controlled Trial. Obstet Gynecol. 2015 Aug;126(2):310-315. doi: 10.1097/AOG.0000000000000958.

    PubMed 26241420

  • Fraticelli F, Celentano C, Zecca IA, Di Vieste G, Pintaudi B, Liberati M, Franzago M, Di Nicola M, Vitacolonna E. Effect of inositol stereoisomers at different dosages in gestational diabetes: an open-label, parallel, randomized controlled trial. Acta Diabetol. 2018 Aug;55(8):805-812. doi: 10.1007/s00592-018-1157-4. Epub 2018 May 17.

    PubMed 29774465

  • D'Anna R, Corrado F, Loddo S, Gullo G, Giunta L, Di Benedetto A. Myoinositol plus alpha-lactalbumin supplementation, insulin resistance and birth outcomes in women with gestational diabetes mellitus: a randomized, controlled study. Sci Rep. 2021 Apr 23;11(1):8866. doi: 10.1038/s41598-021-88329-x.

    PubMed 33893377

  • Vitale SG, Corrado F, Caruso S, Di Benedetto A, Giunta L, Cianci A, D'Anna R. Myo-inositol supplementation to prevent gestational diabetes in overweight non-obese women: bioelectrical impedance analysis, metabolic aspects, obstetric and neonatal outcomes - a randomized and open-label, placebo-controlled clinical trial. Int J Food Sci Nutr. 2021 Aug;72(5):670-679. doi: 10.1080/09637486.2020.1852191. Epub 2020 Nov 25.

    PubMed 33238798

  • Farren M, Daly N, McKeating A, Kinsley B, Turner MJ, Daly S. The Prevention of Gestational Diabetes Mellitus With Antenatal Oral Inositol Supplementation: A Randomized Controlled Trial. Diabetes Care. 2017 Jun;40(6):759-763. doi: 10.2337/dc16-2449. Epub 2017 Mar 21.

    PubMed 28325784

  • Kulshrestha V, Balani S, Kachhawa G, Vanamail P, Kumari R, Sharma JB, Bhatla N. Efficacy of myoinositol in treatment of gestational diabetes mellitus in Asian Indian women: A pilot randomized clinical trial. Eur J Obstet Gynecol Reprod Biol. 2021 May;260:42-47. doi: 10.1016/j.ejogrb.2021.02.017. Epub 2021 Feb 19.

    PubMed 33721623

  • Amaefule CE, Drymoussi Z, Gonzalez Carreras FJ, Pardo Llorente MDC, Lanz D, Dodds J, Sweeney L, Pizzo E, Thomas A, Heighway J, Daru J, Sobhy S, Poston L, Khalil A, Myers J, Harden A, Hitman G, Khan KS, Zamora J, Perez T, Huda MSB, Thangaratinam S. Myo-inositol nutritional supplement for prevention of gestational diabetes (EMmY): a randomised, placebo-controlled, double-blind pilot trial with nested qualitative study. BMJ Open. 2022 Mar 11;12(3):e050110. doi: 10.1136/bmjopen-2021-050110.

    PubMed 35277398

  • Horgan R, Hage Diab Y, Fishel Bartal M, Sibai BM, Saade G. Continuous Glucose Monitoring in Pregnancy. Obstet Gynecol. 2024 Feb 1;143(2):195-203. doi: 10.1097/AOG.0000000000005374. Epub 2023 Sep 28.

    PubMed 37769316

  • Garcia-Moreno RM, Benitez-Valderrama P, Barquiel B, Gonzalez Perez-de-Villar N, Hillman N, Lora Pablos D, Herranz L. Efficacy of continuous glucose monitoring on maternal and neonatal outcomes in gestational diabetes mellitus: a systematic review and meta-analysis of randomized clinical trials. Diabet Med. 2022 Jan;39(1):e14703. doi: 10.1111/dme.14703. Epub 2021 Oct 13.

    PubMed 34564868

Questions about this trial

What is this clinical trial studying?

A study testing Myo-inositol in people with Pregnancy Related, run by Tufts Medical Center at 1 site in United States.

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 9 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 29 Apr 2025. 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 United States. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zeinab Kassem, MD (617-636-9897, zeinab.kassem@tuftsmedicine.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Eligibility (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06575868, which also lists 28 linked publications.

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 29 Apr 2025.

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