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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A,1 | Experimental | Gestational diabetes patients who take myo-inositol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| myo-inositol | Dietary Supplement | 2 g twice a day until delivery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin sensitivity index (HOMA-IR) and continuous glucose monitoring profile | Change from baseline in HOMA-IR at 8 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| baby weight at delivery | After delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| rosario d'anna, professor | Contact | 39-090-2211 | 3809 | rosariodanna@tin.it |
| Name | Affiliation | Role |
|---|---|---|
| Rosario D'Anna, professor | University of Messina, ITALY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Messina - | Recruiting | Messina | Sicily | 98100 | Italy |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| C562602 | Glucose-Galactose Malabsorption |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D007294 | Inositol |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |