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Myo-inositol in Obese Pregnant Women

Primary Purpose

Gestational Diabetes

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
myo-inositol
folic acid 400 mcg
Sponsored by
University of Messina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Diabetes focused on measuring gestational diabetes, macrosomia, hypertension in pregnancy, HOMA-IR, obesity

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

myo-inositol

placebo

Arm Description

acid folic 400 mcg twice per day

Outcomes

Primary Outcome Measures

number of gestational diabetes cases diagnosed with OGTT
difference in HOMA values

Secondary Outcome Measures

incidence of pregnancy complications: hypertension, preterm delivery. macrosomia, shoulder dystocia, etc.

Full Information

First Posted
January 12, 2010
Last Updated
February 27, 2014
Sponsor
University of Messina
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1. Study Identification

Unique Protocol Identification Number
NCT01047982
Brief Title
Myo-inositol in Obese Pregnant Women
Official Title
Myo-inositol May Prevent Gestational Diabetes in Obese Women
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Messina

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
Keywords
gestational diabetes, macrosomia, hypertension in pregnancy, HOMA-IR, obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
myo-inositol
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
acid folic 400 mcg twice per day
Intervention Type
Dietary Supplement
Intervention Name(s)
myo-inositol
Intervention Description
myo-inositol 2 grams plus folic acid 400 mcg twice a day
Intervention Type
Other
Intervention Name(s)
folic acid 400 mcg
Intervention Description
2 pills a day
Primary Outcome Measure Information:
Title
number of gestational diabetes cases diagnosed with OGTT
Time Frame
24-28th weeks gestation
Title
difference in HOMA values
Time Frame
from first trimester to OGTT
Secondary Outcome Measure Information:
Title
incidence of pregnancy complications: hypertension, preterm delivery. macrosomia, shoulder dystocia, etc.
Time Frame
at delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosario D'Anna, professor
Organizational Affiliation
University of Messina, ITALY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Obstetrics and Gynecology Unit, University of Messina and Obstetrics and Gynecology Unit of Modena University
City
Messina and Modena
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
26241420
Citation
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.
Results Reference
derived

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Myo-inositol in Obese Pregnant Women

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