Myo-inositol Administration in Gestational Diabetes
Primary Purpose
Gestational Diabetes Mellitus
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
myo-inositol
Sponsored by
About this trial
This is an interventional supportive care trial for Gestational Diabetes Mellitus focused on measuring gestational diabetes mellitus, carbohydrate intolerance, myo-inositol, insulin resistance
Eligibility Criteria
Inclusion Criteria:
- Gestational diabetes diagnosed within 28 weeks
- Caucasian pregnant women
Exclusion Criteria:
- Non Caucasian pregnant women
- Delivery before 8 weeks of treatment
Sites / Locations
- University of Messina -Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A,1
Arm Description
Gestational diabetes patients who take myo-inositol
Outcomes
Primary Outcome Measures
Insulin sensitivity index (HOMA-IR) and continuous glucose monitoring profile
Secondary Outcome Measures
baby weight at delivery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00734448
Brief Title
Myo-inositol Administration in Gestational Diabetes
Official Title
Effect of Myo-inositol Administration on Insulin Sensitivity in Gestational Diabetes Patients by Continuous Glucose Monitoring System (CGMS)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Messina
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus
Keywords
gestational diabetes mellitus, carbohydrate intolerance, myo-inositol, insulin resistance
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A,1
Arm Type
Experimental
Arm Description
Gestational diabetes patients who take myo-inositol
Intervention Type
Dietary Supplement
Intervention Name(s)
myo-inositol
Intervention Description
2 g twice a day until delivery
Primary Outcome Measure Information:
Title
Insulin sensitivity index (HOMA-IR) and continuous glucose monitoring profile
Time Frame
Change from baseline in HOMA-IR at 8 weeks of treatment
Secondary Outcome Measure Information:
Title
baby weight at delivery
Time Frame
After delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Gestational diabetes diagnosed within 28 weeks
Caucasian pregnant women
Exclusion Criteria:
Non Caucasian pregnant women
Delivery before 8 weeks of treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
rosario d'anna, professor
Phone
39-090-2211
Ext
3809
Email
rosariodanna@tin.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosario D'Anna, professor
Organizational Affiliation
University of Messina, ITALY
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Messina -
City
Messina
State/Province
Sicilia
ZIP/Postal Code
98100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
francesco corrado, researcher
Phone
39-090-2211
Ext
2176
Email
francesco.corrado@unime.it
First Name & Middle Initial & Last Name & Degree
rosario d'anna, professor
First Name & Middle Initial & Last Name & Degree
francesco corrado, researcher
12. IPD Sharing Statement
Learn more about this trial
Myo-inositol Administration in Gestational Diabetes
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