Clinical trial NCT02149992: Glycemic Impact of Myo-inositol in Pregnancy
Official title: Glycemic Impact of Myo-inositol in High Risk and Gestational Diabetic Pregnancies: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes Mellitus as Antepartum Condition
Keywords: gestational diabetes
myoinositol
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Duke University
name: Washington University School of Medicine
First posted: 2014-05-29
Enrollment: 40
Sex: FEMALE
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: overall mean glucose
timeFrame: 7 days
Secondary outcomes:
measure: metabolic differences
timeFrame: 1,4,7 days
Other outcomes:
measure: side effects
timeFrame: day 1,4,7,10
measure: steady state
timeFrame: day 1, 4, 7
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Test Organization
name: Amy M Valent, DO
role: PRINCIPAL_INVESTIGATOR
References: