Myo-inositol supplementation for the prevention of gestational diabetes

• Register: ISRCTN
• Last refreshed on: 26 June 2023
• Main ID: ISRCTN16142533
• Date of registration: 09/03/2017
• Prospective Registration: Yes
• Primary sponsor: Alexandra Hospital
• Public title: Myo-inositol supplementation for the prevention of gestational diabetes
• Scientific title: The effect of dietary myo-inositol supplementation on the insulin resistance and the prevention of gestational diabetes
• Date of first enrolment: 01/01/2018
• Target sample size: 160
• Recruitment status: Ongoing
• URL: https://www.isrctn.com/ISRCTN16142533
• Study type: Interventional
• Study design: Single-centre open-label prospective randomised trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Greece

Contacts

• Name: Georgios Asimakopoulos

• Name: Georgios Daskalakis

Key inclusion & exclusion criteria

Inclusion criteria: Current inclusion criteria as of 21/11/2017:
1. Female
2. Age over 18 years
3. Singleton pregnancies
4. Absence of pre-existing impaired glucose tolerance

Previous inclusion criteria:
1. Female
2. Age over 18 years
3. Singleton pregnancies
4. Diagnosis of diet-treated gestational diabetes (24 - 28 weeks of gestation)
Exclusion criteria: Current exclusion criteria as of 21/11/2017:
1. Age under 18 years
2. Multiple pregnancy
3. Pre-existing diabetes mellitus
4. Consumption of steroids
5. Hypertensive disorders
6. Hypothyroidism
7. Pre-existing renal or hepatic impairment
8. Beta thalassaemia carriers
9. Vaginal bleeding (e.g. placental abruption)
10. Special diets (e.g. lactose intolerance)
11. Inadequate monitoring during pregnancy

Previous exclusion criteria:
1. Age under 18 years
2. Multiple pregnancy
3. Diagnosed diabetes mellitus before 24 - 28 weeks of gestation
4. Requirement of insulin therapy during the period of myo-inositol supplementation
5. Chronic hypertension
6. Preeclampsia, eclampsia
7. Hypothyroidism
8. Pre-existing renal or hepatic impairment
9. Other chronic diseases (e.g. valvular heart disease)
10. Vaginal bleeding (e.g. placental abruption)
11. Special diets (e.g. lactose intolerance)
12. Inadequate monitoring during pregnancy

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Gestational diabetes mellitus
Pregnancy and Childbirth
Diabetes mellitus arising in pregnancy

Intervention(s)

Current interventions as of 21/11/2017:
The participants will be randomized to two groups according to the ID number they get when they visit the hospital. According to this method, one group will consist of participants whose ID numbers are even numbers and the other group will consist of participants whose ID numbers are odd numbers.

1. Treatment group: Myo-inositol and Folic acid from 11 – 13+6 weeks of gestation until the time of gestational diabetes diagnosis (26 – 28 weeks of gestation); myo-inositol, oral, 2g, two times per day; folic
acid, oral, 200 micrograms, two times per day
2. Control group: Folic acid from 11 – 13+6 weeks of gestation until the time of gestational diabetes diagnosis (26 – 28 weeks of gestation); folic acid, oral, 400 micrograms, one time per day

At the time of study entry (11-13+6 weeks of gestation), measurements of fasting blood glucose and glycated hemoglobin will be performed for all participants of both groups. At 19 – 20 weeks of gestation, the same measurements will be repeated for all participants. Finally, at 26 - 28 weeks of gestation, the 2 hour 75 gr Oral Glucose Tolerance Test (OGTT) will be offered for the diagnosis of gestational diabetes. Insulin resistance of all participants will also be evaluated via homeostasis model assessment of insulin resistance (HOMA-IR) and Matsuda Index. Also, the incidence rate of diet-treated gestational diabetes and diabetes requiring insulin therapy will be evaluated after the diagnosis of gestational diabetes at 26-28 weeks of gestation. All above parameters will be recorded in a database and analyzed with the appropriate statistical method.

Previous interventions:
The participants will be randomized to two groups according to the ID number they get when they visit the hospital. Accordin

Primary Outcome(s)

Current primary outcome measures:
Gestational diabetes incidence rate, evaluated by the results of a 75 g oral glucose tolerance test at 26 - 28 weeks of gestation

Previous primary outcome measures:
Insulin resistance level, evaluated by homeostasis model assessment of insulin resistance (HOMA-IR) - measured at baseline (24-28 weeks of gestation) and after 6 weeks (after intervention)

Secondary Outcome(s)

Current secondary outcome measures as of 21/11/2017:
1. Fasting blood glucose levels, measured by blood test at 26-28 weeks of gestation (after intervention)
2. Glycated hemoglobin levels, measured by blood test at 26-28 weeks of gestation (after intervention)
3. Insulin resistance level, evaluated by homeostasis model assessment of insulin resistance (HOMA-IR) and Matsuda Index at 26-28 weeks of gestation (after intervention)
4. Incidence rate of diet-treated gestational diabetes and diabetes requiring insulin therapy, evaluated at 26-28 weeks of gestation (after intervention)

Previous secondary outcome measures:
1. Blood glucose at 0-60 mins, measured by blood test at baseline (24-28 weeks of gestation) and after 6 weeks (after intervention)
2. Glycated hemoglobin, measured by blood test at baseline (24-28 weeks of gestation) and after 6 weeks (after intervention)
3. Fasting insulin, measured by blood test at baseline (24-28 weeks of gestation) and after 6 weeks (after intervention)
4. Fetal biometry at third trimester, measured using ultrasound measurements (biparietal diameter [BPD], head circumference [HC], abdominal circumference [AC], femur length [FL]), measured at 32 - 34 weeks of gestation
5. Requiring insulin therapy, estimated during 6 weeks of intervention
6. Delivery data (gestational age at delivery, birth weight, mode of delivery, indication of labor induction or caesarean section, Apgar score measured using the Apgar Scoring System), estimated from the end of the 6 week intervention till delivery time
7. Adverse obstetric outcome, estimated from the end of the 6 week intervention till delivery time:
7.1. Macrosomia - birth weight greater than 4500g
7.2. Intrauterine growth restriction, estimated using the Fetal Growth Charts - fetal weight below the 10th percentile for the gestational age
7.3. Preeclampsia - systolic blood pressure (SBP) greater than or equal to 140 mm Hg or a diastolic blood pressure (DBP) greater than or equal to 90 mm Hg or higher, on two occasions at least 4 hours apart in a previously normotensive patient AND proteinuria of greater than or equal to 0.3 grams in a 24-hour urine specimen, a protein (mg/dL)/creatinine (mg/dL) ratio of 0.3 or higher, or a urine dipstick protein of 1+
7.4. Placental abruption, estimated by clinical symptoms and ultrasound imaging
7.5. Fetal death
7.6. Neonatal jaundice requiring phototherapy
7.7. Hospitalization in a neonatal care unit
7.8. The hospitalization period (days)
7.9. Acute respiratory distress syndrome (ARDS)
7.10. Necrotizing enterocolitis (NEC)
7.11. Intraventricular hemorrhage (IVH) Grade III and IV
7.12. Neonatal death
7.13. Postnatal maternal complications: fever (temperature under the arm (axillary) at or over 37.2 °C), wound suppuration, embolism

Secondary ID(s)

N/A

Source(s) of Monetary Support

Investigator initiated and funded

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; 1. Scientific Board of Alexandra Hospital, 23/11/2016, ref: 717/09-11-2016 2. Scientific Board of Alexandra Hospital, 28/06/2017, ref: 520/22-06-2017

Results

• Results available: Yes
• Date Completed: 01/08/2023