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

NCT01511835 | Unknown Phase 4

• 1 other identifier: MyoIN_diab
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gestational Diabetes

Keywords

diabetes; pregnancy; myo-inositol

Outcome Measures

Primary Outcomes (1)

• OGTT

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

Secondary Outcomes (5)

• 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)

Study Arms (3)

Myo-inositol powder

EXPERIMENTAL

Dietary Supplement: inositol + folic acid

Myo-inositol soft gel capsules

EXPERIMENTAL

Dietary Supplement: inositol + folic acid

Folic acid

PLACEBO COMPARATOR

Drug: Folic Acid

Interventions

inositol + folic acid DIETARY_SUPPLEMENT

2000 mg of inositol+200mcg of folic acid; 2 per diem

Myo-inositol powder

Folic Acid DRUG

Folic Acid 400mcg; 1 cp/die

Folic acid

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pregnant women affected by pregestational diabetes
• Twin pregnancy
• Patients affected by pre-existing diseases in pregnancy (diabetes excluded)
• Patients affected by chronic disorders

Sponsors & Collaborators

• AGUNCO Obstetrics and Gynecology Centre: lead

Study Sites (1)

AGUNCO

Rome, 00155, Italy

RECRUITING

Related Publications (3)

• 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.

  PMID: 19800728 BACKGROUND

• 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.

  PMID: 21414183 BACKGROUND

• 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.

  PMID: 36790138 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational; Diabetes Mellitus

Interventions

Inositol; Folic Acid

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Vittorio Unfer

CONTACT

vunfer@gmail.com

Gianfranco Carlomagno

CONTACT

gianfranco.carlomagno@agunco.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2011
• First Posted: January 19, 2012
• Last Updated: January 19, 2012

Record last verified: 2012-01

Locations

IT (1)