Myoinositol Supplementation, Insulin Resistance and Fetal Sonographic Parameters in Gestational Diabetes Diet Treated
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus; Insulin Resistance
Study type: Interventional

Summary: 
      The aim of this study is to verify the beneficial effects on insulin resistance and fetal
      sonographic parameters of a diet supplementation of myoinositol taken during the third
      trimester by pregnant women affected by gestational diabetes. Participants should be randomly
      allocated to take either myoinositol or placebo twice/day for 8 weeks. The effect of
      myoinositol will be checked in blood samples (insulinemia and Homeostasis Model Assessment -
      Insulin Resistance "HOMA-IR") and in fetal sonographic parameters after 4 and 8 weeks from
      the beginning of the nutritional supplementation.
    

Detailed description: 
      Background and Aim:

      Gestational diabetes mellitus (GDM) is a carbohydrate intolerance diagnosed during pregnancy
      that is not clearly an overt diabetes. It is characterized by an increase of the
      physiological insulin resistance of the pregnancy status. Myo-Inositol is an insulin
      sensitizing agent that ameliorate the insulin resistance. The investigators have already
      demonstrated that myoinositol, administered in first half of pregnancy, may reduce insulin
      resistance and GDM incidence in pregnant women at risk for family history, obesity and
      overweight . But the experiences in women affected by GDM are few and controversial. So the
      aim of this study is to test the effectiveness of myoinositol to ameliorate the insulin
      resistance in GDM patients, diet treated. Moreover the investigators would like to verify the
      impact of this nutritional supplementation on the fetal sonographic parameters.

      Design:

      The study is a randomized, prospective, placebo-controlled trial, including the first 80
      consecutive gestational diabetes patients diagnosed, according to the Italian Guidelines,
      from November 2018 to December 2019, in the Department of Obstetric and Gynecology of Messina
      University (ITALY). After an informed consent participants will be randomly assigned to
      receive (n. 40) diet and folic acid (400 mcg per day) alone, or (n. 40) diet, folic acid (400
      mcg per day) and myo-inositol (2 g. twice a day + 50 mg alfa-lactalbumin) supplementation.
      Multiple pregnancy or known or suspected fetal congenital abnormality had been previously
      excluded. The insulin sensitivity index (HOMA-IR) and fetal sonographic profile will be
      monitor for each patient at GDM diagnosis and after 4 and 8 weeks of treatment. The pregnant
      women who will delivery before the time treatment (8 weeks) or who need insulin will be
      excluded.
    

Intervention name(s): Myoinositol; Placebo (for myoinositol)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): myo-inositol (2 g. twice a day); (twice a day)
Other intervention name(s): Folic acid; Folic acid
Intervention MeSH terms: Folic Acid; Vitamin B Complex; Inositol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomly assigned to receive (n. 40) diet and folic acid (400 mcg per day) alone, or (n. 40) diet, folic acid (400 mcg per day) and myoinositol (2 g. twice a day + 50 mg alfa-lactalbumin) supplementation. The insulin sensitivity index (HOMA-IR) and fetal sonographic profile will be monitor for each patient at GDM diagnosis and after 4 and 8 weeks of treatment.
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Insulin resistance; Fetal sonographic parameter; Myoinositol