Improved Outcomes Associated With Inositol Dietary Supplementation in Women With Gestational Diabetes Mellitus

Gestational Diabetes Mellitus Clinical Trial

— inositol  

Official title:

Improved Maternal and Fetal Outcomes Associated With Inositol Dietary Supplementation in Women With Early Gestational Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01342874
• Other study ID #: INOS001
• Status: Completed
• Phase: N/A
• First received: April 19, 2011
• Last updated: February 8, 2012
• Start date: August 2010
• Est. completion date: August 2011

Study information

• Verified date: April 2011
• Source: G. d'Annunzio University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Objective: Insulin resistance during normal pregnancy and in gestational diabetes mellitus (GDM) are unknown. New criteria are based on fasting glucose levels since the beginning of pregnancy. Inositol, a putative second messenger of insulin, correlates with the degree of insulin resistance. Dietary supplementation of inositol improves insulin resistance in patients with GDM.

Description:

Methods: A randomized double-blind study was carried out in women with GDM. Patients were randomly exposed to inositol and placebo. Increase of BMI, blood glucose at 75 grams oral glucose tolerance test (OGTT), fetal and neonatal adverse outcome, and insulin treatment were correlated to inositol exposure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• singleton pregnant women

• random fasting glucose above 92 mg%

Exclusion Criteria:

• BMI >30

• random fasting glucose above 126 mg%

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

Dietary Supplement:
• Inositol
inositol exposure in early GDM

Locations

Country	Name	City	State
Italy	University of Chieti	Chieti	CH

Sponsors (1)

Lead Sponsor	Collaborator
G. d'Annunzio University

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin therapy in early diagnosis of GDM	Inositol supplementation and diet with/without insulin therapy in early GDM	6 months	Yes
Primary	altered OGTT	OGTT altered at 24-28 wks in inositol and control group	6 months	Yes
Secondary	delivery and neonatal outcomes	prevention of maternal and fetal adverse outcomes deriving from GDM (LGA fetuses, poly-hydramnios, C-section rate, gestational age at delivery, birthweight, birth injuries)	6 months	Yes