Τίτλος:
Effect of dietary myo-inositol supplementation on the insulin resistance and the prevention of gestational diabetes mellitus: Study protocol for a randomized controlled trial
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
Background: Gestational diabetes mellitus (GDM) is defined as impaired glucose tolerance with onset or first recognition during pregnancy, which is characterized by an increased insulin resistance. Gestational diabetes mellitus is associated with pregnancy-related maternal and fetal morbidity (both antenatal and perinatal). Myo-inositol has been suggested to improve insulin resistance in women with polycystic ovary syndrome. The aim of this study is to examine the impact of myo-inositol supplementation during pregnancy on the incidence of gestational diabetes mellitus. Methods: We will conduct a single-center, open-label, randomized controlled trial. A total of 160 healthy pregnant women with singleton pregnancy at 11-13+6 weeks of gestation will be randomly allocated in two groups: intervention group (N = 80) and control group (N = 80). The intervention group will receive myo-inositol and folic acid (4000 mg myo-inositol and 400 mcg folic acid daily) from 11 to 13+6 weeks of gestation until 26-28 weeks of gestation, while the control group will receive folic acid alone (400 mcg folic acid daily) for the same period of time as intervention group. The primary outcome will be gestational diabetes incidence rate at 26-28 weeks of gestation, according to the results of a 75 g oral glucose tolerance test held at 26-28 weeks of gestation. The secondary outcomes will include fasting blood glucose levels, glycated hemoglobin levels, insulin resistance level (evaluated by homeostasis model assessment of insulin resistance and Matsuda Index), and incidence rate of diet-treated gestational diabetes and diabetes requiring insulin therapy at 26-28 weeks of gestation. Discussion: This trial will provide evidence for the effectiveness of myo-inositol supplementation during pregnancy in reducing the incidence of gestational diabetes mellitus. Trial registration: ISRCTN registry: ISRCTN16142533. Registered on 9 March 2017. © 2020 The Author(s).
Συγγραφείς:
Asimakopoulos, G.
Pergialiotis, V.
Anastasiou, E.
Antsaklis, P.
Theodora, M.
Vogiatzi, E.
Kallergi, A.
Sindos, M.
Loutradis, D.
Daskalakis, G.
Εκδότης:
BioMed Central Ltd.
Λέξεις-κλειδιά:
folic acid; glucose; glycosylated hemoglobin; inositol; glycosylated hemoglobin; inositol, adult; Article; clinical outcome; controlled study; diet supplementation; drug effect; drug efficacy; drug safety; endocrine function test; female; gestational age; glucose blood level; hemoglobin blood level; homeostasis model assessment; human; incidence; insulin resistance; insulin treatment; major clinical study; Matsuda Index; open study; oral glucose tolerance test; outcome assessment; pregnancy; pregnancy diabetes mellitus; prevalence; randomized controlled trial; dietary supplement; glucose tolerance test; Greece; insulin resistance; metabolism; physiology; pregnancy diabetes mellitus; randomized controlled trial (topic), Diabetes, Gestational; Dietary Supplements; Female; Glucose Tolerance Test; Glycated Hemoglobin A; Greece; Humans; Incidence; Inositol; Insulin Resistance; Pregnancy; Randomized Controlled Trials as Topic
DOI:
10.1186/s13063-020-04561-2
