Glycemic Impact of Myo-inositol in Pregnancy

Not Applicable

• Conditions: Gestational Diabetes Mellitus as Antepartum Condition
• Interventions: Dietary Supplement: myo-inositol; Device: Continuous glucose monitoring surveillance; Device: Glucose monitoring

• Registration Number: NCT02149992
• Lead Sponsor: Oregon Health and Science University

Brief 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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-05-25
• Study First Submitted QC: 2014-05-25
• Study First Posted: 2014-05-29
• Study Start: 2014-11
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-05-18
• Primary Completion: 2016-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Myo-inositol, folic acid	Continuous glucose monitoring surveillance	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, folic acid	myo-inositol	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, folic acid	Glucose monitoring	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

Primary Outcome Measures

Name	Time	Method
overall mean glucose	7 days	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.

Secondary Outcome Measures

Name	Time	Method
metabolic differences	1,4,7 days	Metabolic differences (myo-inositol, chiro-inositol, fasting insulin, c-peptide, and adiponectin) pre and post supplementation.

Trial Locations

Locations (1)

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States