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

Gestational Diabetes Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01511835
• Other study ID #: MyoIN_diab
• Status: Recruiting
• Phase: Phase 4
• First received: November 16, 2011
• Last updated: January 13, 2012

Study information

• Verified date: January 2012
• Source: AGUNCO Obstetrics and Gynecology Centre
• Contact: Vittorio Unfer
• Email: vunfer[@]gmail.com
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

Dietary Supplement:
• inositol + folic acid
2000 mg of inositol+200mcg of folic acid; 2 per diem
• inositol + folic acid
600 mg of inositol + 200mcg of folic acid; 2 cp per diem

Drug:
• Folic Acid
Folic Acid 400mcg; 1 cp/die

Locations

Country	Name	City	State
Italy	AGUNCO	Rome

Sponsors (1)

Lead Sponsor	Collaborator
AGUNCO Obstetrics and Gynecology Centre

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OGTT	The diagnostic 75g oral glucose tolerance test (OGTT) is performed between 24 and 28 weeks of gestation.
Secondary	Number of pregnant women with gestational diabetes
Secondary	Number of pregnant women requiring insulin treatment
Secondary	Weight gain at the end of pregnancy
Secondary	Number of newborn infants whose weight is more than 4000 g
Secondary	Number of newborn infants requiring Neonatal Intensive Care (NIC)