Efficacy of Myo-inositol in Preventing Gestational Diabetes in High-risk Pregnant Women

NCT ID: NCT01511835

Last Updated: 2012-01-19

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

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The aim of this study is to evaluate the efficacy of myo-inositol in preventing gestational diabetes in high risk pregnant women.

Detailed Description

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Conditions

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Gestational Diabetes

Study Groups

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Myo-inositol powder

Group Type EXPERIMENTAL

inositol + folic acid

Intervention Type DIETARY_SUPPLEMENT

2000 mg of inositol+200mcg of folic acid; 2 per diem

Myo-inositol soft gel capsules

Group Type EXPERIMENTAL

inositol + folic acid

Intervention Type DIETARY_SUPPLEMENT

600 mg of inositol + 200mcg of folic acid; 2 cp per diem

Folic acid

Group Type PLACEBO_COMPARATOR

Folic Acid

Intervention Type DRUG

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

Intervention Type DIETARY_SUPPLEMENT

inositol + folic acid

600 mg of inositol + 200mcg of folic acid; 2 cp per diem

Intervention Type DIETARY_SUPPLEMENT

Folic Acid

Folic Acid 400mcg; 1 cp/die

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

60 women in their first trimester of pregnancy affected by one or more of the following risk factors:

* 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

* Pregnant women affected by pregestational diabetes
* Twin pregnancy
* Patients affected by pre-existing diseases in pregnancy (diabetes excluded)
* Patients affected by chronic disorders
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AGUNCO Obstetrics and Gynecology Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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AGUNCO

Rome, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Vittorio Unfer

Role: CONTACT

Gianfranco Carlomagno

Role: CONTACT

Facility Contacts

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Gianfranco Carlomagno

Role: primary

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.

Reference Type BACKGROUND
PMID: 19800728 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21414183 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36790138 (View on PubMed)

Other Identifiers

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MyoIN_diab

Identifier Type: -

Identifier Source: org_study_id

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