An interventional study of Folic acid and Myo-inositol in Gestational Diabetes Mellitus, sponsored by Università degli Studi 'G. d'Annunzio' Chieti e Pescara. Status unknown at 1 site in Italy. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2014-03-26.
Sponsored by Università degli Studi 'G. d'Annunzio' Chieti e Pescara · Not applicable, Interventional, and Treatment
The investigators aim to compare the effect of different inositol stereoisomers supplementation in lowering insulin resistance levels after 8 weeks of treatment in pregnant women with GDM and in preventing adverse obstetric outcomes.
The study population includes 80 women with GDM, randomly allocated to subgroup A (folic acid 400 mcg/day), subgroup B (myo-inositol 2000 mg twice a day), subgroup C (D-chiro-inositol 250 mg twice a day), and subgroup D (Myo-inositol plus D-chiro-inositol 550mg/13,8 mg twice a day).
Folic acid or inositol stereoisomers will be administered starting at the enrolling time (24-28 week gestation, after GDM diagnosis) till the delivery.
The homeostasis model assessment of insulin resistance (HOMA-IR) and the sensitivity index (QUICKI) will be checked at the moment of the diagnostic oral glucose tolerance test (24-28 weeks) and after 8 weeks of treatment. Obstetric outcomes, the rate of women needed insulin therapy and insulin dosage will be registered.
Gestational diabetes mellitus (GDM) is defined as carbohydrate intolerance that begins or is first recognized during pregnancy (1). It is characterized by an increase of physiological insulin resistance and it is associated with an increased risk of perinatal and maternal morbidity (2,3).
Inositol is a six-carbon polyol, normally present in a variety of foods, which has been classified as an insulin sensitizing agent. It exists as nine different isomers including myo-inositol (MI) and D-chiro-inositol (DCI) that are the most represented in human body. Myo-inositol and D-chiro-inositol glycans administration has been reported to exert beneficial effects at metabolic, hormonal and ovarian levels (4-5).
Recently has been demonstrated that Myo-inositol supplementation improves insulin resistance in patients with GDM (6), whereas there aren't data about the use of D-chiro-inositol or Myo-inositol plus D-chiro-inositol in women affected by GDM.
In this proposed study, the investigators aim to compare the effect of different inositol stereoisomers supplementation (Myo-inositol, D-chiro-inositol or Myo-inositol plus D-chiro-inositol ) in lowering insulin resistance levels after 8 weeks of treatment in pregnant women with GDM and in preventing adverse obstetric outcomes. All the available inositol formulations also contain folic acid (200 mcg).
The study population includes 80 women with GDM, randomly allocated to subgroup A (folic acid 400 mcg/day), subgroup B (myo-inositol 2000 mg twice a day), subgroup C (D-chiro-inositol 250 mg twice a day), and subgroup D (Myo-inositol plus D-chiro-inositol 550mg/13,8 mg twice a day).
Dietary control, folic acid or inositol stereoisomers will be administered starting at the enrolling time (24-28 week gestation, after GDM diagnosis) till the delivery.
The homeostasis model assessment of insulin resistance (HOMA-IR) and the sensitivity index (QUICKI) will be checked at the moment of the diagnostic oral glucose tolerance test (24-28 weeks) and after 8 weeks of treatment. Obstetric outcomes, the rate of women needed insulin therapy and insulin dosage will be registered.
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
This study's planned enrollment of 80 is below the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Università degli Studi 'G. d'Annunzio' Chieti e Pescara is the lead sponsor of 14 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
folic acid 400 mcg/day
Dietary Supplement: Folic acid
myo-inositol 2000 mg twice a day
Dietary Supplement: Myo-inositol
D-chiro-inositol 250 mg twice a day
Dietary Supplement: D-Chiro-inositol
Myo-inositol plus D-chiro inositol 550mg/13,8 mg twice a day
Dietary Supplement: Myo-inositol plus D-chiro inositol
Folic acid 400 mcg/day
myo-inositol 2000 mg twice a day
D-chiro inositol 250 mg twice a day
Myo-inositol plus D-chiro inositol 550mg/13,8 mg twice a day
Insulin resistance level evaluated by homeostasis model assessment of insulin resistance (HOMA-IR)
Time frame: 56 days- 8 weeks
hypertensive disorders
Time frame: 56 days- 8 weeks
macrosomia
Time frame: at delivery
cesarean section
Time frame: at delivery
neonatal hypoglycemia
Time frame: at delivery
jaundice requiring phototherapy
Time frame: within the first 2 weeks after delivery
lipid profile
Time frame: 56 days- 8 weeks
insulin therapy requirements
Time frame: 56 days- 8 weeks
This study is status unknown, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Università degli Studi 'G. d'Annunzio' Chieti e Pescara