Efficacy of Myo-inositol in Preventing Gestational Diabetes in High-risk Pregnant Women
NCT ID: NCT01511835
Last Updated: 2012-01-19
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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UNKNOWN
PHASE4
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Groups
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Myo-inositol powder
inositol + folic acid
2000 mg of inositol+200mcg of folic acid; 2 per diem
Myo-inositol soft gel capsules
inositol + folic acid
600 mg of inositol + 200mcg of folic acid; 2 cp per diem
Folic acid
Folic Acid
Folic Acid 400mcg; 1 cp/die
Interventions
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inositol + folic acid
2000 mg of inositol+200mcg of folic acid; 2 per diem
inositol + folic acid
600 mg of inositol + 200mcg of folic acid; 2 cp per diem
Folic Acid
Folic Acid 400mcg; 1 cp/die
Eligibility Criteria
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Inclusion Criteria
* Glycemia levels \> 92 mg/dl
* BMI \> 30
* At least a parent or a brother (or sister)affected by diabetes
* Pre-existing pregnancy with gestational diabetes
Exclusion Criteria
* Twin pregnancy
* Patients affected by pre-existing diseases in pregnancy (diabetes excluded)
* Patients affected by chronic disorders
20 Years
45 Years
FEMALE
No
Sponsors
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AGUNCO Obstetrics and Gynecology Centre
OTHER
Responsible Party
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Locations
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AGUNCO
Rome, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Papaleo E, Unfer V, Baillargeon JP, Chiu TT. Contribution of myo-inositol to reproduction. Eur J Obstet Gynecol Reprod Biol. 2009 Dec;147(2):120-3. doi: 10.1016/j.ejogrb.2009.09.008. Epub 2009 Oct 2.
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.
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.
Other Identifiers
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MyoIN_diab
Identifier Type: -
Identifier Source: org_study_id
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