Myo-inositol in Obese Pregnant Women | NCT01047982

Studies
Myo-inositol in Obese Pregnant Women

NCT01047982

Sponsor

University of Messina

Status

Completed

Last Update Posted

Feb 28, 2014Estimated

Enrollment

220Actual

Phase

Not Applicable

Conditions

Gestational Diabetes

Interventions

myo-inositol
folic acid 400 mcg

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Jul 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jan 12, 2010

First Submission Date that Met QC Criteria

Jan 12, 2010

First Posted Date

Jan 13, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2014

Last Update Posted Date

Feb 28, 2014Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

220Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
myo-inositol	Active Comparator		Dietary Supplement: myo-inositol
placebo	Placebo Comparator	acid folic 400 mcg twice per day	Other: folic acid 400 mcg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
myo-inositol	Dietary Supplement	myo-inositol 2 grams plus folic acid 400 mcg twice a day	myo-inositol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of gestational diabetes cases diagnosed with OGTT		24-28th weeks gestation
difference in HOMA values		from first trimester to OGTT

Secondary Outcomes

Measure	Description	Time Frame
incidence of pregnancy complications: hypertension, preterm delivery. macrosomia, shoulder dystocia, etc.		at delivery

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rosario D'Anna, professor	University of Messina, ITALY	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Obstetrics and Gynecology Unit, University of Messina and Obstetrics and Gynecology Unit of Modena University		Messina and Modena			Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36790138	Derived	Motuhifonua SK, Lin L, Alsweiler J, Crawford TJ, Crowther CA. Antenatal dietary supplementation with myo-inositol for preventing gestational diabetes. Cochrane Database Syst Rev. 2023 Feb 15;2(2):CD011507. doi: 10.1002/14651858.CD011507.pub3.
26241420	Derived	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.

ID	Term
D016640	Diabetes, Gestational
D046110	Hypertension, Pregnancy-Induced
D009765	Obesity

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D003920	Diabetes Mellitus

ID	Term
D007294	Inositol
D005492	Folic Acid

ID	Term
D013402	Sugar Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D002241	Carbohydrates