Improved Outcomes Associated With Inositol Dietary Supplementation in Women With Gestational Diabetes Mellitus (inositol)
February 8, 2012 updated by: Claudio Celentano, G. d'Annunzio University
Improved Maternal and Fetal Outcomes Associated With Inositol Dietary Supplementation in Women With Early Gestational Diabetes Mellitus
Objective: Insulin resistance during normal pregnancy and in gestational diabetes mellitus (GDM) are unknown.
New criteria are based on fasting glucose levels since the beginning of pregnancy.
Inositol, a putative second messenger of insulin, correlates with the degree of insulin resistance.
Dietary supplementation of inositol improves insulin resistance in patients with GDM.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Methods: A randomized double-blind study was carried out in women with GDM.
Patients were randomly exposed to inositol and placebo.
Increase of BMI, blood glucose at 75 grams oral glucose tolerance test (OGTT), fetal and neonatal adverse outcome, and insulin treatment were correlated to inositol exposure.
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
CH
-
Chieti, CH, Italy, 66100
- University of Chieti
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 41 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
pregnant women presenting random fasting glucose during the first half of pregnancy above 92 mg%
Description
Inclusion Criteria:
- singleton pregnant women
- random fasting glucose above 92 mg%
Exclusion Criteria:
- BMI >30
- random fasting glucose above 126 mg%
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Inositol group
Inositol dietary exposure 4000 mg/day
|
inositol exposure in early GDM
|
|
Control group
folic acid 400 mcg/day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Insulin therapy in early diagnosis of GDM
Time Frame: 6 months
|
Inositol supplementation and diet with/without insulin therapy in early GDM
|
6 months
|
|
altered OGTT
Time Frame: 6 months
|
OGTT altered at 24-28 wks in inositol and control group
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
delivery and neonatal outcomes
Time Frame: 6 months
|
prevention of maternal and fetal adverse outcomes deriving from GDM (LGA fetuses, poly-hydramnios, C-section rate, gestational age at delivery, birthweight, birth injuries)
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Claudio Celentano, MD, ObGyn Dept
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
April 19, 2011
First Submitted That Met QC Criteria
April 26, 2011
First Posted (Estimate)
April 27, 2011
Study Record Updates
Last Update Posted (Estimate)
February 9, 2012
Last Update Submitted That Met QC Criteria
February 8, 2012
Last Verified
April 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INOS001
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