Myo-inositol for Preventing Gestational Diabetes in Overweight and Obese Women

This study is currently recruiting participants.

Verified January 2013 by University of Messina

Sponsor:

Information provided by (Responsible Party):

Rosario D'anna, University of Messina

ClinicalTrials.gov Identifier:

NCT01047982

First received: January 12, 2010

Last updated: January 22, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	January 12, 2010
Last Updated Date	January 22, 2013
Start Date ^ICMJE	March 2010
Estimated Primary Completion Date	June 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 15, 2013)	number of gestational diabetes cases diagnosed with OGTT [ Time Frame: 24-28th weeks gestation ] [ Designated as safety issue: No ] difference in HOMA values [ Time Frame: from first trimester to OGTT ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: January 12, 2010)	number of gestational diabetes cases diagnosed with OGTT [ Time Frame: 26-28th weeks gestation ] [ Designated as safety issue: No ] fetal weight at delivery [ Time Frame: at delivery ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01047982 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 22, 2013)	incidence of pregnancy complications: hypertension, preterm delivery. macrosomia, shoulder dystocia, etc. [ Time Frame: at delivery ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: January 12, 2010)	number of gestational hypertension cases [ Time Frame: at delivery ] [ Designated as safety issue: No ] serum triglycerides and total cholesterol [ Time Frame: at delivery ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Myo-inositol for Preventing Gestational Diabetes in Overweight and Obese Women
Official Title ^ICMJE	Not Provided
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, placebo-controlled study. Two hundred overweight and 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
Condition ^ICMJE	Gestational Diabetes
Intervention ^ICMJE	Dietary Supplement: myo-inositol myo-inositol 2 grams plus folic acid 400 mcg twice a day Other: folic acid 400 mcg 2 pills a day
Study Arm (s)	Active Comparator: myo-inositol Intervention: Dietary Supplement: myo-inositol Placebo Comparator: placebo acid folic 400 mcg twice per day Intervention: Other: folic acid 400 mcg
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	200
Estimated Completion Date	October 2013
Estimated Primary Completion Date	June 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Overweight pregnant women: BMI > 25 Kg/cm2 first trimester fast glycaemia < 100 mg/dl single pregnancy caucasian women Exclusion Criteria: Pregnant women with BMI < 25 Kg/cm2 first trimester fast glycaemia > 100 mg/dl previous gestational diabetes twin pregnancy non caucasian women pregestational diabetes associated therapies with corticosteroids PCOS women
Gender	Female
Ages	18 Years to 45 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Italy

Administrative Information
NCT Number ^ICMJE	NCT01047982
Other Study ID Numbers ^ICMJE	INOGDM-2010
Has Data Monitoring Committee	Not Provided
Responsible Party	Rosario D'anna, University of Messina
Study Sponsor ^ICMJE	University of Messina
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Messina
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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