Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2014-11-30
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Myo-inositol, folic acid
1. myo-inositol, oral, 2g, two times per day for 5 total days
2. folic acid, oral 200 micrograms, two times per day for 7 days
3. Continuous Glucose Monitoring Surveillance device for 7 days during study period
4. Capillary glucose monitoring 4 times per day
myo-inositol
myo-inositol, oral, 2g, twice a day for 5 days total
Continuous glucose monitoring surveillance
monitoring device will be placed by experienced research members to the patient on Day 1 and she will continue to wear until Day 7. This device monitors overall glycemia every 5 minutes and records the information, which can be downloaded after discontinued.
Glucose monitoring
patients will use the glucose meter, test strips, and lancets to determine her capillary glucose levels 4 times per day (fasting, and 1 hour post-prandial levels)
Interventions
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myo-inositol
myo-inositol, oral, 2g, twice a day for 5 days total
Continuous glucose monitoring surveillance
monitoring device will be placed by experienced research members to the patient on Day 1 and she will continue to wear until Day 7. This device monitors overall glycemia every 5 minutes and records the information, which can be downloaded after discontinued.
Glucose monitoring
patients will use the glucose meter, test strips, and lancets to determine her capillary glucose levels 4 times per day (fasting, and 1 hour post-prandial levels)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* singleton
* pregnant females between 20-28 weeks of gestation at time of enrollment PLUS (either of the following)
* High risk including women must have passed routine glucose screening and have greater than or equal to 1 of the following high risk criteria: first degree family member with diabetes mellitus, previous pregnancy with gestational diabetes, PCOS, or body mass index great than or equal to 30.
* Gestational diabetes diagnosed in current pregnancy based on IADPSG or NIH consensus diagnostic recommendation
Exclusion Criteria
* renal disease
* immunocompromised
* currently taking immunosuppressive medications
* age \<13 years old
* non-English speaking
* multifetal gestation.
13 Years
FEMALE
Yes
Sponsors
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Duke University
OTHER
Washington University School of Medicine
OTHER
Oregon Health and Science University
OTHER
Responsible Party
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Amy Valent
DO; Assistant Professor
Principal Investigators
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Amy M Valent, DO
Role: PRINCIPAL_INVESTIGATOR
Test Organization
Locations
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Oregon Health and Science University
Portland, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2014-1676
Identifier Type: -
Identifier Source: org_study_id
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