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Myo-inositol, D-chiro-inosito...

Myo-inositol, D-chiro-inositol, and D-chiro/Myo-inositol in Gestational Diabetes

NCT ID: NCT01762826

Last Updated: 2013-01-08

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

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-09-30

Brief Summary

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Comparison of different inositol stereoisomears in preventing adverse obstetric outcomes in non-obese pregnant women at high risk for gestational diabetes mellitus.

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Detailed Description

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The investigators compared outcomes from metabolic and obstetric point of view in GDM pregnant non-obese patient with different stereoisomears of inositol supply. Dietary control and placebo or inositol steroisomears were administered starting at the enrolling time (first fasting oral glucose above 92 mg%; usually before 20 weeks gestations') till the delivery and/or pregnancy end/termination. Oral glucose tolerance test results at 24-28 weeks' gestation was evaluated (as glucose values and oGTT screening). Fetal growth, delivery data, obstetric outcomes and necessity of insulin therapy were taken into account.

Conditions

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GDM

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Placebo control

Diet pills of 400 mcg of acid folic daily

Placebo

Intervention Type DIETARY_SUPPLEMENT

Dietary control plus folic acid 400 mcg daily

D-chiro-inositol / Myo-inositol

Diet sachets 2000 mg myo-inositol and 250 mg d-chiro-inositol and 400 mcg folic acid daily

D-Chiro / Myo-inositol

Intervention Type DIETARY_SUPPLEMENT

Dietary control Supplementation with myo and d-chiro inositol

D-chiro-inositol

Diet pills with 500 mg d-chiro-inositol and 400 mcg folic acid daily

D-chiro-inositol

Intervention Type DIETARY_SUPPLEMENT

Dietary control plus D-Chiro-Inositol supplementation

Myo-inositol

Diet sachets with 2000 mg myo-inositol and 200 mcg folic acid twice daily

Myo-inositol

Intervention Type DIETARY_SUPPLEMENT

Dietary control plus Myo-inositol

Interventions

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Myo-inositol

Dietary control plus Myo-inositol

Intervention Type DIETARY_SUPPLEMENT

D-chiro-inositol

Dietary control plus D-Chiro-Inositol supplementation

Intervention Type DIETARY_SUPPLEMENT

D-Chiro / Myo-inositol

Dietary control Supplementation with myo and d-chiro inositol

Intervention Type DIETARY_SUPPLEMENT

Placebo

Dietary control plus folic acid 400 mcg daily

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Supplementation of myo-inositol plus dietary control

Eligibility Criteria

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Inclusion Criteria

* pregnancy below 20 weeks gestation BMI below 30 Fasting glucose between 92 and 126 mg% Singleton pregnancy Naturally conceived

Exclusion Criteria

* obese patient Fasti g glucose above 126 or below 92

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Chieti

OTHER

Sponsor Role collaborator

G. d'Annunzio University

OTHER

Sponsor Role lead

Responsible Party

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Claudio Celentano

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudio Celentano, MD

Role: STUDY_DIRECTOR

ObGyn Dept University of Chieti

Barbara Matarrelli, MD

Role: PRINCIPAL_INVESTIGATOR

ObGyn Dept Univ of Chieti

Ester Vitacolonna, MD

Role: STUDY_CHAIR

Diabetology Dept Univ of Chieti

Other Identifiers

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INOS002

Identifier Type: -

Identifier Source: org_study_id

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