Gestational Diabetes Mellitus as Antepartum Condition
Conditions
Keywords
gestational diabetes, myoinositol
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.
Interventions
DIETARY_SUPPLEMENTmyo-inositol
myo-inositol, oral, 2g, twice a day for 5 days total
DEVICEContinuous 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.
DEVICEGlucose 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)
Sponsors
Duke University
Washington University School of Medicine
Oregon Health and Science University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
13 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| metabolic differences | 1,4,7 days | Metabolic differences (myo-inositol, chiro-inositol, fasting insulin, c-peptide, and adiponectin) pre and post supplementation. |
Other
| Measure | Time frame | Description |
|---|---|---|
| side effects | day 1,4,7,10 | Through patient surveys, will determine side effect profiles of the supplement |
| steady state | 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. |
Countries
United States
Contacts
Primary ContactAmy M Valent, DO
Backup ContactLeonardo Pereira, MD
Outcome results
None listed