Myo-inositol Administration in Gestational Diabetes

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Gestational Diabetes Mellitus	Dietary Supplement: myo-inositol	Not Applicable

Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	30 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Supportive Care
Official Title:	Effect of Myo-inositol Administration on Insulin Sensitivity in Gestational Diabetes Patients by Continuous Glucose Monitoring System (CGMS)
Study Start Date :	November 2013
Estimated Primary Completion Date :	November 2014
Estimated Study Completion Date :	December 2014

Arms and Interventions

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Arm	Intervention/treatment
Experimental: A,1; Gestational diabetes patients who take myo-inositol	Dietary Supplement: myo-inositol; 2 g twice a day until delivery

Outcome Measures

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Primary Outcome Measures :

1. Insulin sensitivity index (HOMA-IR) and continuous glucose monitoring profile [ Time Frame: Change from baseline in HOMA-IR at 8 weeks of treatment ]

Secondary Outcome Measures :

1. baby weight at delivery [ Time Frame: After delivery ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 44 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Gestational diabetes diagnosed within 28 weeks
• Caucasian pregnant women

Exclusion Criteria:

• Non Caucasian pregnant women
• Delivery before 8 weeks of treatment

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: rosario d'anna, professor	39-090-2211 ext 3809	rosariodanna@tin.it

Locations

Italy
University of Messina -	Recruiting
Messina, Sicilia, Italy, 98100
Contact: francesco corrado, researcher 39-090-2211 ext 2176 francesco.corrado@unime.it
Principal Investigator: rosario d'anna, professor
Sub-Investigator: francesco corrado, researcher

Sponsors and Collaborators

University of Messina

Investigators

Principal Investigator:	Rosario D'Anna, professor	University of Messina, ITALY

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Rosario D'anna, associate professor, University of Messina
ClinicalTrials.gov Identifier:	NCT00734448 History of Changes
Other Study ID Numbers:	Myo-1954
First Posted:	August 14, 2008
Last Update Posted:	June 13, 2014
Last Verified:	June 2014

Keywords provided by Rosario D'anna, University of Messina:

gestational diabetes mellitus; carbohydrate intolerance; myo-inositol; insulin resistance

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes, Gestational; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications	Inositol; Vitamin B Complex; Vitamins; Micronutrients; Growth Substances; Physiological Effects of Drugs