The Impact of Myo-Inositol on Glycemic Control and Oxidative Stress in Gestational Diabetes Mellitus

Official title

The Impact of Myo-Inositol Supplementation on Glycemic Control and Oxidative Stress in Women With Gestational Diabetes Mellitus: A Randomized, Open-Label Pilot Study

Overview

The purpose of this clinical study is to investigate the potential effects of myo-inositol supplementation on changes in glycemic control parameters, oxidative stress, inflammatory biomarkers, psychometric markers, and body composition in participants with gestational diabetes mellitus (GDM). The study duration is 3 to 3.5 months, depending on the time of GDM diagnosis. Before the active phase begins, there is a 10-day observation period during which participants' blood glucose levels are monitored using a continuous glucose monitoring device. In the subsequent 12-14-week study phase, participants will receive a supplement based on random group assignment. They will be allocated either to an intervention group (myo-inositol + folic acid) or a control group (folic acid). Both supplements will be taken until delivery. The intervention group supplement contains 4 g myo-inositol and 400 μg folic acid (BIOGENA GmbH, Salzburg) and is to be taken twice daily with water - three capsules per meal. The control group supplement contains only 400 μg folic acid (BIOGENA GmbH, Salzburg) and is also taken twice daily, one capsule per meal. As this is a pilot study, both participants and study personnel will be aware of group assignments. Blood glucose measurements will be repeated mid-study (around the 33rd week of pregnancy) and at the end (37th week of pregnancy) using glucose sensors. To improve the evaluation of glucose measurements, participants will keep dietary logs during these periods. Three study visits are planned, during which the following assessments will be conducted. To determine the primary outcome, "time in range (TIR)" (time spent within the target glucose range), three glucose sensor measurements will be performed. At each visit, blood samples will be taken to analyze glycemic control parameters (hemoglobin A1c (HbA1c), fasting glucose, fasting insulin, Homeostasis Model Assessment (HOMA-IR), insulin dosage), oxidative stress markers (total antioxidant capacity, malondialdehyde levels), and inflammatory markers (interleukin-6 (IL-6), C-reactive protein (CRP)). Anthropometric measurements (weight gain, blood pressure, pulse) and body composition (Bioelectrical Impedance Analysis) will also be performed. Additionally, maternal and fetal birth outcomes will be recorded, including cesarean section rates, fetal gestational weight, preterm birth rates, and neonatal hypoglycemia occurrence. To assess participants' well-being and physical activity, questionnaires will be distributed at the beginning and end of the study.

Interventions

• Dietary supplement Myo-inositol 2 g + Folic acid 200 µg
  This dietary supplement contains 2 g of myo-inositol and 200 µg folic acid per capsule. It should be taken twice a day (à 3 capsules) with fluid intake and a meal.
• Dietary supplement Folic acid 200 µg
  This dietary supplement contains 200 μg of folic acid per capsule and should also be taken twice a day (à 1 capsule) with adequate fluid intake and a main meal.
• Drug Insulin therapy
  Women with GDM who maintain their blood glucose levels with insulin therapy.
• Behavioral Nutrition therapy
  Women with GDM who maintain their blood sugar levels with nutritional therapy.

Primary outcome measures

• Time in Range [Time frame: 10 days at baseline (24.-28. gestational week), 10 days into gestational week 33, 10 days into gestational week 36/37]

Secondary outcome measures (12)

• Fasting glucose [Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week]
• Fasting insulin [Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week]
• HOMA-IR [Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week]
• HbA1c [Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week]
• Insulin doses [Time frame: from day 1 until delivery]
• Pre Pregnancy BMI [Time frame: before pregnancy]
• Height in meters [Time frame: at baseline]
• Weight in kilograms [Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week]
• Blood Pressure [Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week]
• C-Section (maternal and fetal outcomes) [Time frame: at delivery]
• Hypoglycemia of the child (maternal and fetal outcomes) [Time frame: at delivery]
• Preterm birth (maternal and fetal outcomes) [Time frame: at delivery]

Eligibility criteria

Inclusion criteria

• GDM diagnosis
• at least one of the HAPO-Study criteria: 2h-oGTT → >153 mg/dl, 1h-oGGT → >180 mg/dl, fasting plasma glucose > 92 mg/dl
• age between 18-45
• single pregnancy

Exclusion criteria

• T2DM
• T1DM
• Maturity Onset Diabetes of the Young (MODY)
• Latent Autoimmune Diabetes in Adults (LADA)
• pre pregnancy BMI >35
• oral antidiabetic drugs
• pre-existing renal disease
• heart disease and other chronic medical disorders
• allergies to any ingredients contained in the dietary supplements

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Austria · 2 centers

• Allgemeines Krankenhaus (AKH) Vienna, Medical University of Vienna — Vienna
• Medical University of Vienna — Vienna

Identifiers

NCT: NCT07685015 · 2469/2024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗