Glycemic Impact of Myo-inositol in Pregnancy

May 17, 2016 updated by: Amy Valent, Oregon Health and Science University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Contact:
        • Principal Investigator:
          • Amy M Valent, DO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Dietary supplement: myo-inositol
myo-inositol, oral, 2g, twice a day for 5 days total
Other Names:
  • Inositol
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.
Other Names:
  • Medtronic CGMS
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)
Other Names:
  • OneTouch glucose meter
  • test strips
  • lancets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall mean glucose
Time Frame: 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.
7 days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
side effects
Time Frame: day 1,4,7,10
Through patient surveys, will determine side effect profiles of the supplement
day 1,4,7,10
steady state
Time Frame: day 1, 4, 7
Determine time (days) of supplement required to reach steady state by measuring pre, 1 day post, and at day 4 after supplementation.
day 1, 4, 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

Washington University School of Medicine
Duke University

Investigators

  • Principal Investigator: Amy M Valent, DO, Test Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

May 25, 2014

First Submitted That Met QC Criteria

May 25, 2014

First Posted (Estimate)

May 29, 2014

Study Record Updates

Last Update Posted (Estimate)

May 18, 2016

Last Update Submitted That Met QC Criteria

May 17, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-1676

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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