Myo-inositol in Obese Pregnant Women

NCT ID: NCT01047982

Last Updated: 2014-02-28

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

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-12-31

Brief Summary

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Myo-Inositol is classified as a member of the vitamin B complex. It is a constituent of living cells and is widespread in many food. It is involved in a number of biological processes, including insulin signal transduction, resulting in modulating insulin sensitivity. This is a prospective, randomized, double center, placebo-controlled study. Two hundred and twenty obese pregnant women will be included in the trial and, after an informed consent, will assume randomly 2 g of myo-inositol twice a day or placebo from 12-13th weeks gestation until delivery. Then,they will perform an Oral Glucose Tolerance Test (OGTT) at 24-28th weeks gestation. Records about delivery (gestational age, neonatal weight...) will be registered.

Detailed Description

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Conditions

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Gestational Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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myo-inositol

Group Type ACTIVE_COMPARATOR

myo-inositol

Intervention Type DIETARY_SUPPLEMENT

myo-inositol 2 grams plus folic acid 400 mcg twice a day

placebo

acid folic 400 mcg twice per day

Group Type PLACEBO_COMPARATOR

folic acid 400 mcg

Intervention Type OTHER

2 pills a day

Interventions

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myo-inositol

myo-inositol 2 grams plus folic acid 400 mcg twice a day

Intervention Type DIETARY_SUPPLEMENT

folic acid 400 mcg

2 pills a day

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Obese pregnant women: BMI \> 30 Kg/cm2
* first trimester fast glycaemia \< 126 mg/dl
* single pregnancy

Exclusion Criteria

* Pregnant women with BMI \< 30 Kg/cm2
* first trimester fast glycaemia \> 126 mg/dl
* previous gestational diabetes
* twin pregnancy
* pregestational diabetes
* associated therapies with corticosteroids
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Messina

OTHER

Sponsor Role lead

Responsible Party

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Rosario D'anna

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rosario D'Anna, professor

Role: PRINCIPAL_INVESTIGATOR

University of Messina, ITALY

Locations

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Obstetrics and Gynecology Unit, University of Messina and Obstetrics and Gynecology Unit of Modena University

Messina and Modena, , Italy

Site Status

Countries

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Italy

References

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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)

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.

Reference Type DERIVED
PMID: 26241420 (View on PubMed)

Other Identifiers

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INOGDM-2010

Identifier Type: -

Identifier Source: org_study_id

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