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

Primary Purpose

Gestational Diabetes

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
inositol + folic acid
inositol + folic acid
Folic Acid
Sponsored by
AGUNCO Obstetrics and Gynecology Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Gestational Diabetes focused on measuring diabetes, pregnancy, myo-inositol

Eligibility Criteria

20 Years - 45 Years (Adult)Female

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

Sites / Locations

  • AGUNCORecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Myo-inositol powder

Myo-inositol soft gel capsules

Folic acid

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Full Information

First Posted
November 16, 2011
Last Updated
January 13, 2012
Sponsor
AGUNCO Obstetrics and Gynecology Centre
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1. Study Identification

Unique Protocol Identification Number
NCT01511835
Brief Title
Efficacy of Myo-inositol in Preventing Gestational Diabetes in High-risk Pregnant Women
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AGUNCO Obstetrics and Gynecology Centre

4. Oversight

5. Study Description

Brief Summary
The aim of this study is to evaluate the efficacy of myo-inositol in preventing gestational diabetes in high risk pregnant women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
Keywords
diabetes, pregnancy, myo-inositol

7. Study Design

Study Phase
Phase 4

8. Arms, Groups, and Interventions

Arm Title
Myo-inositol powder
Arm Type
Experimental
Arm Title
Myo-inositol soft gel capsules
Arm Type
Experimental
Arm Title
Folic acid
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
inositol + folic acid
Intervention Description
2000 mg of inositol+200mcg of folic acid; 2 per diem
Intervention Type
Dietary Supplement
Intervention Name(s)
inositol + folic acid
Intervention Description
600 mg of inositol + 200mcg of folic acid; 2 cp per diem
Intervention Type
Drug
Intervention Name(s)
Folic Acid
Intervention Description
Folic Acid 400mcg; 1 cp/die
Primary Outcome Measure Information:
Title
OGTT
Description
The diagnostic 75g oral glucose tolerance test (OGTT) is performed between 24 and 28 weeks of gestation.
Secondary Outcome Measure Information:
Title
Number of pregnant women with gestational diabetes
Title
Number of pregnant women requiring insulin treatment
Title
Weight gain at the end of pregnancy
Title
Number of newborn infants whose weight is more than 4000 g
Title
Number of newborn infants requiring Neonatal Intensive Care (NIC)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vittorio Unfer
Email
vunfer@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gianfranco Carlomagno
Email
gianfranco.carlomagno@agunco.it
Facility Information:
Facility Name
AGUNCO
City
Rome
ZIP/Postal Code
00155
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gianfranco Carlomagno
Email
gianfranco.carlomagno@agunco.it
First Name & Middle Initial & Last Name & Degree
Vittorio Unfer
First Name & Middle Initial & Last Name & Degree
Gianfranco Carlomagno

12. IPD Sharing Statement

Citations:
PubMed Identifier
19800728
Citation
Papaleo E, Unfer V, Baillargeon JP, Chiu TT. Contribution of myo-inositol to reproduction. Eur J Obstet Gynecol Reprod Biol. 2009 Dec;147(2):120-3. doi: 10.1016/j.ejogrb.2009.09.008. Epub 2009 Oct 2.
Results Reference
background
PubMed Identifier
21414183
Citation
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.
Results Reference
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Efficacy of Myo-inositol in Preventing Gestational Diabetes in High-risk Pregnant Women

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