Myo-inositol for Reduction of Insulin Therapy in Gestational Diabetes Mellitus
NCT ID: NCT03875755
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
1080 participants
INTERVENTIONAL
2020-03-04
2027-01-20
Brief Summary
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MYO-INOSITOL (MI) is an oral dietary supplement, which reduces insulin resistance. Women with GDM are deficient in MI. MI supplementation safely prevents GDM by 65 to 87% in high-risk women. A pilot study has shown a 75% reduction of the need for insulin during GDM not controlled by diet.
The coordinator investigator propose here, for the first time, a randomized controlled study evaluating MI versus placebo in women with newly diagnosed GDM.
Detailed Description
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1. In the 23 participating centers selection of women with GDM between 6 to 37 (+6 days) amenorrhea weeks
2. Explanation of protocol, with signature of consent in case of acceptation.
3. Randomization
* Experimental group: The women will receive 2 caps of MI with acid folic a day, until delivery
* Control group: The women will receive 2 caps of placebo (containing only acid folic) a day, until delivery
In both arms, the participants will be routinely followed up during pregnancy:
* diet education,
* self-monitoring of blood glucose before and after meals
* and during follow-up insulin therapy if glucose value targets are unmet
4. Routine monitoring of the women with GDM in both arms, up to delivery, without use of other oral hypoglycemic agents during pregnancy.
At delivery:
* MI (or placebo) will be stopped
* Events during pregnancy will be collected
5. Last visit three months after delivery. Oral glucose tolerance test, anthropometric measures for women and their child.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Myo Inositol
The women will receive 2 caps of Myo Inositol with acid folic a day, until delivery
Myo Inositol
One soft gel capsule containing MI 600 mg and folic acid 200 μg twice a day, until delivery.
Placebo
The women will receive 2 caps of placebo (acid folic) a day, until delivery
Placebo
One soft gel capsule of placebo (folic acid 200 μg) twice a day until delivery.
Interventions
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Myo Inositol
One soft gel capsule containing MI 600 mg and folic acid 200 μg twice a day, until delivery.
Placebo
One soft gel capsule of placebo (folic acid 200 μg) twice a day until delivery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Singleton pregnancy
* GDM diagnosed during pregnancy according to IADPSG (International Association of the Diabetes and Pregnancy Study Groups) criteria, i.e.
* fasting plasma glucose between 92 mg/dL (5.1 mmol/L) and 125 mg/dL (6.9 mmol/L)
* and/or 1-hour plasma glucose value after 75 g oral glucose tolerance test (OGTT) ≥ 180 mg/dL (10.0 mmol/L)
* and/or 2-hour plasma glucose value between 153 mg/dL (8.5 mmol/L) and 199 mg/dL ((11.0 mmol/L)
* or overt diabetes according to 2-hours post OGTT plasma glucose value ≥ 200 mg/dl
* 6 to 37 (+6 days) amenorrhea weeks at the time of randomization
* Capacity for self-monitoring of blood glucose
* Signed informed consent
Exclusion Criteria
* Use of other oral hypoglycemic agents during this pregnancy
* Long time corticosteroid treatment
* Pre-existing diabetes before pregnancy
* Overt diabetes diagnosed during pregnancy according to fasting plasma glucose ≥ 126 mg/dL (7 mmol/l)
* Lack of Social Insurance
* Insufficient French understanding and speaking
* Participant in another investigational drug study at inclusion visit
* Fetal malformation diagnosed by previous fetal ultrasound
* Personal history of any bariatric surgery
* Hypersensitivity to any ingredient of dietary supplement formulation
18 Years
45 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Emmanuel COSSON, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hôpital Avicenne
Bobigny, , France
Hopital Avicenne
Bobigny, , France
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Lubin V, Shojai R, Darmon P, Cosson E. A pilot study of gestational diabetes mellitus not controlled by diet alone: First-line medical treatment with myoinositol may limit the need for insulin. Diabetes Metab. 2016 Jun;42(3):192-5. doi: 10.1016/j.diabet.2016.01.005.
Other Identifiers
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P160940J
Identifier Type: -
Identifier Source: org_study_id