Glycemic Impact of Myo-inositol in Pregnancy

Study Overview
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Brief Summary
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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.

Detailed Description
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Myo-inositol is important for glucose homeostasis and has been shown to improve insulin sensitivity. This is a prospective cohort pilot study to determine daily glycemic pharmacokinetics and metabolic influences of myo-inositol supplementation using continuous glucose monitoring system (CGMS) and pre- and post-supplement blood work in high risk pregnancies and women diagnosed with gestational diabetes mellitis (GDM). Risk factors include: obesity, previous pregnancy with GDM, family history of diabetes, glucose intolerance, and polycystic ovarian syndrome (PCOS). Women will have a CGMS device placed on day one and begin with 3 days of placebo plus folic acid (400mcg) to determine baseline glycemia and metabolic levels. For the final 4 days, women with take myo-inositol supplementation (4g) plus folic acid (400mcg). The CGMS device will be removed on day 7 when final blood work will be obtained. Self-capillary glucose testing 4 times per day is recorded to calibrate CGMS glucose values. These observations will help determine the effects of myo-inositol on overall mean glucose and other metabolic factors in high risk and GDM patients, identify pharmacokinetic discipline in pregnancy, and develop the groundwork for future prospective clinical trials for the prevention and/or augmentation in treatment GDM.

Official Title
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Glycemic Impact of Myo-inositol in High Risk and Gestational Diabetic Pregnancies: a Pilot Study

Conditions
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Gestational Diabetes Mellitus as Antepartum Condition

Intervention / Treatment
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* Dietary Supplement: myo-inositol
* Device: Continuous glucose monitoring surveillance
* Device: Glucose monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English-speaking 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: pre-pregnancy diagnosis of diabetes mellitus renal disease immunocompromised currently taking immunosuppressive medications age <13 years old non-English speaking multifetal gestation.

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Myo-inositol, folic acid<br>myo-inositol, oral, 2g, two times per day for 5 total days folic acid, oral 200 micrograms, two times per day for 7 days Continuous Glucose Monitoring Surveillance device for 7 days during study period Capillary glucose monitoring 4 times per day | Dietary Supplement: myo-inositol<br>* myo-inositol, oral, 2g, twice a day for 5 days total<br>* Other names: Inositol;Device: Continuous glucose monitoring surveillance<br>* 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.<br>* Other names: Medtronic CGMS;Device: Glucose monitoring<br>* 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)<br>* Other names: lancets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall mean glucose | Difference in overall mean glucose with folic acid alone versus myo-inositol+folic acid supplementation; measured by continuous glucose monitoring system started pre-supplementation and continued for 4 days after supplementation. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| metabolic differences | Metabolic differences (myo-inositol, chiro-inositol, fasting insulin, c-peptide, and adiponectin) pre and post supplementation. | 1,4,7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gestational diabetes, myoinositol