Improved Outcomes Associated With Inositol Dietary Supplementation in Women With Gestational Diabetes Mellitus

NCT ID: NCT01342874

Last Updated: 2012-02-09

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

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-08-31

Brief Summary

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Objective: Insulin resistance during normal pregnancy and in gestational diabetes mellitus (GDM) are unknown. New criteria are based on fasting glucose levels since the beginning of pregnancy. Inositol, a putative second messenger of insulin, correlates with the degree of insulin resistance. Dietary supplementation of inositol improves insulin resistance in patients with GDM.

Detailed Description

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Methods: A randomized double-blind study was carried out in women with GDM. Patients were randomly exposed to inositol and placebo. Increase of BMI, blood glucose at 75 grams oral glucose tolerance test (OGTT), fetal and neonatal adverse outcome, and insulin treatment were correlated to inositol exposure.

Conditions

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Gestational Diabetes Mellitus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Inositol group

Inositol dietary exposure 4000 mg/day

Inositol

Intervention Type DIETARY_SUPPLEMENT

inositol exposure in early GDM

Control group

folic acid 400 mcg/day

No interventions assigned to this group

Interventions

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Inositol

inositol exposure in early GDM

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* singleton pregnant women
* random fasting glucose above 92 mg%

Exclusion Criteria

* BMI \>30
* random fasting glucose above 126 mg%
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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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: PRINCIPAL_INVESTIGATOR

ObGyn Dept

Locations

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University of Chieti

Chieti, CH, Italy

Site Status

Countries

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Italy

References

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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)

Other Identifiers

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INOS001

Identifier Type: -

Identifier Source: org_study_id

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