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

RecruitingNAAges 18 Years - 45 YearsFemaleMedical University of Vienna
NCT07685015 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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 ฮผg

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * GDM diagnosis * at least one of the HAPO-Study criteria: 2h-oGTT โ†’ \>153 mg/dl, 1h-oGGT โ†’ \>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
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What it tests

  • Myo-inositol 2 g + Folic acid 200 ยตg
  • Folic acid 200 ยตg
  • Insulin therapy
  • Nutrition therapy
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Where

2 sites
Allgemeines Krankenhaus (AKH) Vienna, Medical University of Vienna
Vienna, Austria
Medical University of Vienna
Vienna, Austria
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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