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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests myo-inositol, a naturally occurring compound, to determine if it can improve insulin sensitivity in pregnant women with gestational diabetes. Participants will receive either myo-inositol or a placebo to compare effects. This trial suits women who are pregnant with one baby, are obese, and plan to give birth at Tufts Medical Center. As an unphased trial, it offers participants the chance to contribute to important research that could benefit future mothers with gestational diabetes.

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.

Is there any evidence suggesting that myo-inositol is likely to be safe for humans?

Research has shown that myo-inositol is generally safe for pregnant women. Studies have found that taking 4 grams of myo-inositol daily can reduce the risk of gestational diabetes, high blood pressure during pregnancy, and early birth, without additional health risks. Specifically, women with gestational diabetes who took myo-inositol required less insulin and achieved better blood sugar control in the last trimester. Overall, myo-inositol appears well-tolerated, with no major side effects reported in these studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for gestational diabetes, which often include insulin therapy or oral medications like metformin, myo-inositol offers a different approach. Myo-inositol is a naturally occurring compound that may help regulate blood sugar levels by improving insulin sensitivity. Researchers are excited about myo-inositol because it presents a potentially safer option with fewer side effects for pregnant women. Additionally, its natural origin could make it a more appealing alternative for those looking to manage gestational diabetes with minimal intervention.

What evidence suggests that myo-inositol might be an effective treatment for gestational diabetes?

Research has shown that myo-inositol supplements can help manage gestational diabetes. One study found that myo-inositol reduced new cases of gestational diabetes by 63% and improved glucose tolerance test results. Another study discovered that taking myo-inositol soon after a gestational diabetes diagnosis helped control blood sugar levels more effectively. It also appears to lower the risk of high blood pressure during pregnancy and early delivery. In this trial, participants will receive either myo-inositol or a placebo. These findings suggest that myo-inositol could be a promising option for improving outcomes in gestational diabetes. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

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

Receiving prenatal care at Tufts Medical Center

Planning to give birth at Tufts Medical Center

Exclusion Criteria

I have diabetes.

Multiple gestation

Wards of the state

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36790138/

Antenatal dietary supplementation with myo-inositol for ... For the primary maternal outcomes, meta-analysis showed that myo-inositol may reduce the incidence of gestational diabetes (risk ratio (RR) 0.53 ...

2. diabetesjournals.org diabetesjournals.org/spectrum/article/38/1/82/157055/Maternal-and-Neonatal-Efficacy-and-Safety-Outcomes

Maternal and Neonatal Efficacy and Safety Outcomes of Myo ... Regarding high-risk pregnancy, six studies (25–27,32–34) showed a significant decrease with inositol treatment compared with placebo (MD 0.55 ...

3. wjgnet.com wjgnet.com/1948-9358/full/v16/i9/107871.htm

Efficacy of inositol supplementation in the prevention and ... Specifically, myo-inositol supplements reduced new GDM cases by 63% and improved glucose tolerance test results. They also decreased chances of ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211521000968

Efficacy of myoinositol in treatment of gestational diabetes ... Oral supplementation with myoinositol in dose of 1 gm twice-daily, when started soon after the diagnosis of GDM, is effective in achieving glycemic control.

5. dmsjournal.biomedcentral.com dmsjournal.biomedcentral.com/articles/10.1186/s13098-022-00862-5

Myo-inositol supplementation for prevention of gestational ... Regarding the pregnancy outcomes, the incidence of gestational hypertension and preterm delivery was significantly lower in the myo-inositol ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10692440/

The Efficacy and Safety of Myo-inositol Supplementation ... While studies show that 4 g myo-inositol per day may decrease the incidence of GDM, pregnancy-induced hypertension and pre-term birth with no associated risk of ...

7. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-022-04852-3

Myoinositol supplementation in the treatment of gestational ... Women with GDM treated with myoinositol showed an improved glycaemic control in the 3 rd trimester of pregnancy and a lower insulin requirement.

8. asean-endocrinejournal.org asean-endocrinejournal.org/index.php/JAFES/article/view/2599

The Efficacy and Safety of Myo-inositol Supplementation ... Studies show that 4 g myo-inositol per day may decrease the incidence of GDM, pregnancy-induced hypertension and pre-term birth with no associated risk of ...