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Myo-inositol Administration in Gestational Diabetes

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00734448
Enrollment
30
Registered
2008-08-14
Start date
2013-11-30
Completion date
2014-12-31
Last updated
2014-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes Mellitus

Keywords

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

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.

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.

Interventions

DIETARY_SUPPLEMENTmyo-inositol

2 g twice a day until delivery

Sponsors

University of Messina
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
Yes

Inclusion criteria

* Gestational diabetes diagnosed within 28 weeks * Caucasian pregnant women

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Insulin sensitivity index (HOMA-IR) and continuous glucose monitoring profileChange from baseline in HOMA-IR at 8 weeks of treatment

Secondary

MeasureTime frame
baby weight at deliveryAfter delivery

Countries

Italy

Contacts

Primary Contactrosario d'anna, professor
rosariodanna@tin.it39-090-2211

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026