Myo-inositol Administration in Gestational Diabetes
Effect of Myo-inositol Administration on Insulin Sensitivity in Gestational Diabetes Patients by Continuous Glucose Monitoring System (CGMS)
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2008
CompletedFirst Posted
Study publicly available on registry
August 14, 2008
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJune 13, 2014
June 1, 2014
1 year
April 16, 2008
June 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Insulin sensitivity index (HOMA-IR) and continuous glucose monitoring profile
Change from baseline in HOMA-IR at 8 weeks of treatment
Secondary Outcomes (1)
baby weight at delivery
After delivery
Study Arms (1)
A,1
EXPERIMENTALGestational diabetes patients who take myo-inositol
Interventions
Eligibility Criteria
You may qualify if:
- Gestational diabetes diagnosed within 28 weeks
- Caucasian pregnant women
You may not qualify if:
- Non Caucasian pregnant women
- Delivery before 8 weeks of treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Messina -
Messina, Sicily, 98100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rosario D'Anna, professor
University of Messina, ITALY
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
April 16, 2008
First Posted
August 14, 2008
Study Start
November 1, 2013
Primary Completion
November 1, 2014
Study Completion
December 1, 2014
Last Updated
June 13, 2014
Record last verified: 2014-06