Improved Outcomes Associated With Inositol Dietary Supplementation in Women With Gestational Diabetes Mellitus
inositol
Improved Maternal and Fetal Outcomes Associated With Inositol Dietary Supplementation in Women With Early Gestational Diabetes Mellitus
1 other identifier
observational
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2010
Shorter than P25 for all trials
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
Study Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 19, 2011
CompletedFirst Posted
Study publicly available on registry
April 27, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedFebruary 9, 2012
April 1, 2011
8 months
April 19, 2011
February 8, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Insulin therapy in early diagnosis of GDM
Inositol supplementation and diet with/without insulin therapy in early GDM
6 months
altered OGTT
OGTT altered at 24-28 wks in inositol and control group
6 months
Secondary Outcomes (1)
delivery and neonatal outcomes
6 months
Study Arms (2)
Inositol group
Inositol dietary exposure 4000 mg/day
Control group
folic acid 400 mcg/day
Interventions
Eligibility Criteria
pregnant women presenting random fasting glucose during the first half of pregnancy above 92 mg%
You may qualify if:
- singleton pregnant women
- random fasting glucose above 92 mg%
You may not qualify if:
- BMI \>30
- random fasting glucose above 126 mg%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Chieti
Chieti, CH, 66100, Italy
Related Publications (1)
Corrado F, D'Anna R, Di Vieste G, Giordano D, Pintaudi B, Santamaria A, Di Benedetto A. The effect of myoinositol supplementation on insulin resistance in patients with gestational diabetes. Diabet Med. 2011 Aug;28(8):972-5. doi: 10.1111/j.1464-5491.2011.03284.x.
PMID: 21414183BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claudio Celentano, MD
ObGyn Dept
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
April 19, 2011
First Posted
April 27, 2011
Study Start
August 1, 2010
Primary Completion
April 1, 2011
Study Completion
August 1, 2011
Last Updated
February 9, 2012
Record last verified: 2011-04