NCT02149992

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

1.8 years

First QC Date

May 25, 2014

Last Update Submit

May 17, 2016

Conditions

Gestational Diabetes Mellitus as Antepartum Condition

Keywords

gestational diabetesmyoinositol

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • metabolic differences

    1,4,7 days

Other Outcomes (2)

  • side effects

    day 1,4,7,10

  • steady state

    day 1, 4, 7

Study Arms (1)

Myo-inositol, folic acid

EXPERIMENTAL

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-inositolDevice: Continuous glucose monitoring surveillanceDevice: Glucose monitoring

Interventions

myo-inositolDIETARY_SUPPLEMENT

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

Also known as: Inositol
Myo-inositol, folic acid
Continuous glucose monitoring surveillanceDEVICE

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.

Also known as: Medtronic CGMS
Myo-inositol, folic acid
Glucose monitoringDEVICE

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)

Also known as: OneTouch glucose meter, test strips, lancets
Myo-inositol, folic acid

Eligibility Criteria

Age13 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Inositol

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Amy M Valent, DO

    Test Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy M Valent, DO

CONTACT

503-502-7220valent@ohsu.edu

Leonardo Pereira, MD

CONTACT

503-494-2101pereiral@ohsu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DO; Assistant Professor

Study Record Dates

First Submitted

May 25, 2014

First Posted

May 29, 2014

Study Start

November 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05

Locations

US(1)