Myo-inositol Administration in Gestational Diabetes

Gestational Diabetes Mellitus Clinical Trial

Official title:

Effect of Myo-inositol Administration on Insulin Sensitivity in Gestational Diabetes Patients by Continuous Glucose Monitoring System (CGMS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00734448
• Other study ID #: Myo-1954
• Status: Recruiting
• Phase: N/A
• First received: April 16, 2008
• Last updated: June 12, 2014
• Start date: November 2013
• Est. completion date: December 2014

Study information

• Verified date: June 2014
• Source: University of Messina
• Contact: rosario d'anna, professor
• Phone: 39-090-2211
• Email: rosariodanna[@]tin.it
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial Summary

Myo-Inositol is an insulin sensitizing agent that ameliorate the insulin resistance in women affected by gestational diabetes (GDM), but there is no information about the effect on the glucose profile. Maternal hyperglycemia of GDM, especially hypoglycemic excursions, are associated with adverse pregnancy outcome. Continuous Glucose Monitoring System (CGMS) is obviously better than intermittent self monitoring in detecting glucose profile and magnitude and duration of glucose fluctuations. For this reason, we propose a clinical trial to analyze the characteristics of glucose variability in GDM women,treated with diet and folic acid alone or with diet, folic acid and myo-inositol supplementation.

Description:

Our study is a randomized, prospective, controlled trial, including the first 30 consecutive Caucasian gestational diabetes patients diagnosed,according the International Association of Diabetes and Pregnancy Study Group (IADPSG) panel criteria, from November 2013 in the Department of Obstetric and Gynecology of Messina University (ITALY). After an informed consent they will be randomly assigned to receive (n. 15) diet and folic acid (400 mcg per day) alone or (n. 15) diet, folic acid (400 mcg per day) and myo-inositol (2 g. twice a day)supplementation. The insulin sensitivity index (HOMA-IR) and the glycemic profile will be monitor by CGMS for each patient at GDM diagnosis and after 8 weeks of treatment The pregnant women who will delivery before the time treatment (8 weeks) or who need insulin will be excluded.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

Inclusion Criteria:

• Gestational diabetes diagnosed within 28 weeks

• Caucasian pregnant women

Exclusion Criteria:

• Non Caucasian pregnant women

• Delivery before 8 weeks of treatment

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

Dietary Supplement:
• myo-inositol
2 g twice a day until delivery

Locations

Country	Name	City	State
Italy	University of Messina -	Messina	Sicilia

Sponsors (1)

Lead Sponsor	Collaborator
University of Messina

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity index (HOMA-IR) and continuous glucose monitoring profile		Change from baseline in HOMA-IR at 8 weeks of treatment	No
Secondary	baby weight at delivery		After delivery	No