Myo-inositol supplementation for the prevention of gestational diabetes

Not Applicable

Completed

• Conditions: Gestational diabetes mellitus; Pregnancy and Childbirth; Diabetes mellitus arising in pregnancy

• Registration Number: ISRCTN16142533
• Lead Sponsor: Alexandra Hospital

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32646482/ protocol (added 13/07/2020) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39141124/ (added 15/08/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-09
• Study Completion: 2023-08-01
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 160

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measures:<br>Gestational diabetes incidence rate, evaluated by the results of a 75 g oral glucose tolerance test at 26 - 28 weeks of gestation<br><br>Previous primary outcome measures:<br>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)