Glycemic Impact of Myo-inositol in Pregnancy
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 13 - Any |
| Updated: | 5/19/2016 |
| Start Date: | November 2014 |
| End Date: | August 2016 |
| Contact: | Amy M Valent, DO |
| Email: | valent@ohsu.edu |
| Phone: | 503-502-7220 |
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.
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.
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.
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.
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.
We found this trial at
1
site
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Principal Investigator: Amy M Valent, DO
Phone: 503-502-7220
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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