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

February 8, 2012 updated by: Claudio Celentano, G. d'Annunzio University

Improved Maternal and Fetal Outcomes Associated With Inositol Dietary Supplementation in Women With Early Gestational Diabetes Mellitus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

30

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
    • CH
      • Chieti, CH, Italy, 66100
        • University of Chieti

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

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

pregnant women presenting random fasting glucose during the first half of pregnancy above 92 mg%

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • BMI >30
  • random fasting glucose above 126 mg%

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?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Inositol group
Inositol dietary exposure 4000 mg/day
Dietary supplement: Inositol
inositol exposure in early GDM
Control group
folic acid 400 mcg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin therapy in early diagnosis of GDM
Time Frame: 6 months
Inositol supplementation and diet with/without insulin therapy in early GDM
6 months
altered OGTT
Time Frame: 6 months
OGTT altered at 24-28 wks in inositol and control group
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
delivery and neonatal outcomes
Time Frame: 6 months
prevention of maternal and fetal adverse outcomes deriving from GDM (LGA fetuses, poly-hydramnios, C-section rate, gestational age at delivery, birthweight, birth injuries)
6 months

Collaborators and Investigators

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

Sponsor

G. d'Annunzio University

Investigators

  • Principal Investigator: Claudio Celentano, MD, ObGyn Dept

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 Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

April 19, 2011

First Submitted That Met QC Criteria

April 26, 2011

First Posted (Estimate)

April 27, 2011

Study Record Updates

Last Update Posted (Estimate)

February 9, 2012

Last Update Submitted That Met QC Criteria

February 8, 2012

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INOS001

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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