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Glycemic Impact of Myo-inositol in Pregnancy

NCT02149992 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-05-18

No results posted yet for this study

Summary

Myo-inositol has been shown to decrease the rate of diabetes in pregnancy in European studies. It is not known exactly how this occurs or what it does to the sugar when the supplement is taken. This study purpose is to look at the patient's sugar levels while taking the supplement to see if the overall levels of sugar go down. We hypothesize that in addition to sugar levels, other hormones influencing diabetes will be altered.

Conditions

  • Gestational Diabetes Mellitus as Antepartum Condition

Interventions

DIETARY_SUPPLEMENT

myo-inositol

myo-inositol, oral, 2g, twice a day for 5 days total

DEVICE

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.

DEVICE

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)

Sponsors & Collaborators

  • Duke University

    collaborator OTHER

  • Washington University School of Medicine

    collaborator OTHER

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Amy M Valent, DO · Test Organization

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02149992 on ClinicalTrials.gov