Myo-inositol for Gestational Diabetes

Overseen By Zeinab Kassem, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Tufts Medical Center

Must not be taking: Metformin

Disqualifiers: Multiple gestation, Preexisting diabetes, others

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

If you are taking medications that affect body weight or metabolism, like metformin, you will need to stop taking them to participate in this trial.

What data supports the effectiveness of the treatment Myo-inositol for gestational diabetes?

Research shows that Myo-inositol can effectively reduce the risk of developing gestational diabetes in pregnant women, especially those who are overweight or obese. Studies have found that women taking Myo-inositol had a lower incidence of gestational diabetes compared to those who did not take it. ^{1 2 3 4 5}

Is myo-inositol safe for use in humans?

Research shows that myo-inositol has a strong safety profile, making it generally safe for use in humans, including pregnant women at risk of gestational diabetes. ^{1 2 3 5 6}

How does the treatment Myo-inositol differ from other treatments for gestational diabetes?

Myo-inositol is unique because it is a naturally occurring sugar that helps improve insulin sensitivity, which can prevent gestational diabetes. Unlike some other treatments, it is taken as a dietary supplement and has shown effectiveness in reducing the risk of developing gestational diabetes, especially in overweight and obese pregnant women. ^{1 5 7 8 9}

What is the purpose of this trial?

Myoinositol is an insulin-like compound that is present in both plant and animal cells. Humans synthesize it naturally, but it is also obtained in our diet. It works through an intracellular signaling pathway to increase insulin sensitivity. Myoinositol has been used as an over-the-counter (OTC) supplement in the management of polycystic ovarian syndrome due to this effect. Myoinositol has also been shown to improve glycemic profiles in pregnant euglycemic women and well as improve insulin sensitivity in pregnant patients with gestational diabetes mellitus (GDM). This is a double blind RCT offering myo-inositol or placebo to those who are eligible and enrolled.

Eligibility Criteria

This trial is for pregnant women aged 18-45, with a pre-pregnancy BMI of 30 or more, receiving care at Tufts Medical Center. They must be less than 16 weeks into their pregnancy, planning to give birth at the same center, and able to wear a Continuous Glucose Monitor (CGM) and tolerate glucose tolerance tests.

Inclusion Criteria

Singleton gestations

Planning to give birth at Tufts Medical Center

Receiving prenatal care at Tufts Medical Center

Exclusion Criteria

I have diabetes.

Multiple gestation

I am taking medication that affects my weight or metabolism.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either myo-inositol or placebo to assess its effect on glucose levels

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Myo-inositol

Trial Overview The study is testing Myo-inositol against a placebo in preventing gestational diabetes during pregnancy. It's a double-blind randomized controlled trial (RCT), meaning neither participants nor researchers know who receives the actual supplement or the placebo.

Participant Groups

Group I: Myo-inositol Experimental Treatment 1 Intervention

Group II: Placebo myo-inositol Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Tufts Medical Center

Lead Sponsor

Trials

264

Recruited

264,000+

References

1. Philippines pubmed.ncbi.nlm.nih.gov

The Efficacy and Safety of Myo-inositol Supplementation for the Prevention of Gestational Diabetes Mellitus in Overweight and Obese Pregnant Women: A Systematic Review and Meta-Analysis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Myo-inositol lowers the risk of developing gestational diabetic mellitus in pregnancies: A systematic review and meta-analysis of randomized controlled trials with trial sequential analysis. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness and acceptability of myo-inositol nutritional supplement in the prevention of gestational diabetes (EMmY): a protocol for a randomised, placebo-controlled, double-blind pilot trial. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Myo-inositol supplementation to prevent gestational diabetes in overweight non-obese women: bioelectrical impedance analysis, metabolic aspects, obstetric and neonatal outcomes - a randomized and open-label, placebo-controlled clinical trial. [2021]

5. Italy pubmed.ncbi.nlm.nih.gov

Treatment of gestational diabetes mellitus with myo-inositol: analyzing the cutting edge starting from a peculiar case. [2018]

6. England pubmed.ncbi.nlm.nih.gov

The efficacy of myo-inositol supplementation to reduce the incidence of gestational diabetes: a meta-analysis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Antenatal dietary supplementation with myo-inositol for preventing gestational diabetes. [2023]

8. England pubmed.ncbi.nlm.nih.gov

The influence of different inositol stereoisomers supplementation in pregnancy on maternal gestational diabetes mellitus and fetal outcomes in high-risk patients: a randomized controlled trial. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Antenatal dietary supplementation with myo-inositol in women during pregnancy for preventing gestational diabetes. [2023]