Clinical trial NCT06575868: Myo-inositol During Pregnancy to Prevent Gestational Diabetes
Official title: Continuous Glucose Monitoring in Myo-inositol Supplemented Obese Pregnant Individuals: a Feasibility Pilot Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Related
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

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

Can tolerate glucose tolerance test

Willing and able to wear CGM

Willing and able to sign informed consent

Exclusion Criteria:

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

Primary outcomes:
measure: Eligibility
timeFrame: 1 year
measure: Glucose levels
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Santamaria A, Di Benedetto A, Petrella E, Pintaudi B, Corrado F, D'Anna R, Neri I, Facchinetti F. Myo-inositol may prevent gestational diabetes onset in overweight women: a randomized, controlled trial. J Matern Fetal Neonatal Med. 2016 Oct;29(19):3234-7. doi: 10.3109/14767058.2015.1121478. Epub 2015 Dec 23.
citation: Pintaudi B, Di Vieste G, Corrado F, Lucisano G, Giunta L, D'Anna R, Di Benedetto A. Effects of myo-inositol on glucose variability in women with gestational diabetes. Eur Rev Med Pharmacol Sci. 2018 Oct;22(19):6567-6572. doi: 10.26355/eurrev_201810_16073.
citation: D'Anna R, Scilipoti A, Giordano D, Caruso C, Cannata ML, Interdonato ML, Corrado F, Di Benedetto A. myo-Inositol supplementation and onset of gestational diabetes mellitus in pregnant women with a family history of type 2 diabetes: a prospective, randomized, placebo-controlled study. Diabetes Care. 2013 Apr;36(4):854-7. doi: 10.2337/dc12-1371. Epub 2013 Jan 22.
citation: Parker ED, Lin J, Mahoney T, Ume N, Yang G, Gabbay RA, ElSayed NA, Bannuru RR. Economic Costs of Diabetes in the U.S. in 2022. Diabetes Care. 2024 Jan 1;47(1):26-43. doi: 10.2337/dci23-0085.
citation: Baptiste-Roberts K, Nicholson WK, Wang NY, Brancati FL. Gestational diabetes and subsequent growth patterns of offspring: the National Collaborative Perinatal Project. Matern Child Health J. 2012 Jan;16(1):125-32. doi: 10.1007/s10995-011-0756-2.
citation: Nestler JE, Jakubowicz DJ, Reamer P, Gunn RD, Allan G. Ovulatory and metabolic effects of D-chiro-inositol in the polycystic ovary syndrome. N Engl J Med. 1999 Apr 29;340(17):1314-20. doi: 10.1056/NEJM199904293401703.
citation: D'Anna R, Di Benedetto V, Rizzo P, Raffone E, Interdonato ML, Corrado F, Di Benedetto A. Myo-inositol may prevent gestational diabetes in PCOS women. Gynecol Endocrinol. 2012 Jun;28(6):440-2. doi: 10.3109/09513590.2011.633665. Epub 2011 Nov 28.
citation: Unfer V, Carlomagno G, Dante G, Facchinetti F. Effects of myo-inositol in women with PCOS: a systematic review of randomized controlled trials. Gynecol Endocrinol. 2012 Jul;28(7):509-15. doi: 10.3109/09513590.2011.650660. Epub 2012 Feb 1.
citation: Matarrelli B, Vitacolonna E, D'Angelo M, Pavone G, Mattei PA, Liberati M, Celentano C. Effect of dietary myo-inositol supplementation in pregnancy on the incidence of maternal gestational diabetes mellitus and fetal outcomes: a randomized controlled trial. J Matern Fetal Neonatal Med. 2013 Jul;26(10):967-72. doi: 10.3109/14767058.2013.766691. Epub 2013 Mar 1.
citation: Celentano C, Matarrelli B, Pavone G, Vitacolonna E, Mattei PA, Berghella V, Liberati M. The influence of different inositol stereoisomers supplementation in pregnancy on maternal gestational diabetes mellitus and fetal outcomes in high-risk patients: a randomized controlled trial. J Matern Fetal Neonatal Med. 2020 Mar;33(5):743-751. doi: 10.1080/14767058.2018.1500545. Epub 2018 Dec 17.
citation: Esmaeilzadeh S, Ghadimi R, Mashayekh-Amiri S, Delavar MA, Basirat Z. The effect of myo-inositol supplementation on the prevention of gestational diabetes in overweight pregnant women: a randomized, double-blind, controlled trial. Minerva Obstet Gynecol. 2023 Aug;75(4):357-364. doi: 10.23736/S2724-606X.22.05036-9. Epub 2022 Jun 8.
citation: Castorino K, Polsky S, O'Malley G, Levister C, Nelson K, Farfan C, Brackett S, Puhr S, Levy CJ. Performance of the Dexcom G6 Continuous Glucose Monitoring System in Pregnant Women with Diabetes. Diabetes Technol Ther. 2020 Dec;22(12):943-947. doi: 10.1089/dia.2020.0085.
citation: Motuhifonua SK, Lin L, Alsweiler J, Crawford TJ, Crowther CA. Antenatal dietary supplementation with myo-inositol for preventing gestational diabetes. Cochrane Database Syst Rev. 2023 Feb 15;2(2):CD011507. doi: 10.1002/14651858.CD011507.pub3.