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

January 13, 2012 updated by: AGUNCO Obstetrics and Gynecology Centre
The aim of this study is to evaluate the efficacy of myo-inositol in preventing gestational diabetes in high risk pregnant women.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00155
        • Recruiting
        • Agunco
        • Contact:
        • Principal Investigator:
          • Vittorio Unfer
        • Principal Investigator:
          • Gianfranco Carlomagno

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 41 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Myo-inositol powder
Dietary supplement: inositol + folic acid
2000 mg of inositol+200mcg of folic acid; 2 per diem
Dietary supplement: inositol + folic acid
600 mg of inositol + 200mcg of folic acid; 2 cp per diem
Experimental: Myo-inositol soft gel capsules
Dietary supplement: inositol + folic acid
2000 mg of inositol+200mcg of folic acid; 2 per diem
Dietary supplement: inositol + folic acid
600 mg of inositol + 200mcg of folic acid; 2 cp per diem
Placebo Comparator: Folic acid
Drug: Folic Acid
Folic Acid 400mcg; 1 cp/die

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
OGTT
The diagnostic 75g oral glucose tolerance test (OGTT) is performed between 24 and 28 weeks of gestation.

Secondary Outcome Measures

Outcome Measure
Number of pregnant women with gestational diabetes
Number of pregnant women requiring insulin treatment
Weight gain at the end of pregnancy
Number of newborn infants whose weight is more than 4000 g
Number of newborn infants requiring Neonatal Intensive Care (NIC)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AGUNCO Obstetrics and Gynecology Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 16, 2011

First Submitted That Met QC Criteria

January 13, 2012

First Posted (Estimate)

January 19, 2012

Study Record Updates

Last Update Posted (Estimate)

January 19, 2012

Last Update Submitted That Met QC Criteria

January 13, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MyoIN_diab

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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