Preventing type 2 diabetes with metformin

Conditions

Specialty: Reproductive Health and Childbirth, Primary sub-specialty: Maternal/ Fetal medicine

Angeliki Bolou, Zoe Drymoussi, Doris Lanz, Chiamaka Esther Amaefule, Francisco Jose Gonzalez Carreras et al. (17 authors)

BMJ Open2023-11-015 citations

10.1136/bmjopen-2023-073813

Effectiveness and acceptability of metformin in preventing the onset of type 2 diabetes after gestational diabetes in postnatal women: a protocol for a randomised, placebo-controlled, double-blind feasibility trial — Optimising health outcomes with Metformin to prevent diAbetes After pregnancy (OMAhA)

Chiamaka Esther Amaefule, Angeliki Bolou, Zoe Drymoussi, Francisco Jose Gonzalez Carreras, María del Carmen Pardo et al. (23 authors)

BMJ Open2020-05-017 citations

10.1136/bmjopen-2019-036198

Interventions

Schedule for study participants As many women as possible who are referred to obstetric diabetes antenatal care will be sent a Patient Information Sheet (PIS) with their hospital appoi

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Women diagnosed with gestational diabetes as per the National Institute for Health and Care Excellence (NICE) criteria, at time of consent 2. Women who are on metformin and/or insulin in pregnancy 3. Aged 16 years or over at the time of consent

Exclusion criteria

Exclusion criteria: 1. Women unable to give informed, written consent in English 2. Pre-existing type 1 diabetes or type 2 diabetes 3. BMI > = 40 kg/m2 4. Known contraindications to metformin 5. Concurrent participation in another interventional clinical trial

Design outcomes

Primary

Measure	Time frame
1. Proportion of eligible women of those screened, measured at baseline 2. Proportion of eligible women who give consent, measured at baseline 3. Proportion of randomised women, of those consented, measured at randomisation 4. Attrition rates, measured at 6-13 weeks, 6 months, and 12 months 5. Adherence rates with intervention, measured at 6-13 weeks, 6 months, and 12 months	—

Secondary

Measure	Time frame
1. Acceptability outcomes: participants’ views on the study and the intervention at 6-13 weeks and 12 months, and healthcare professionals’ views on the barriers to recruitment, adherence and retention at the end of the study 2. Clinical and economic outcomes: maternal dysglycaemia, insulin metabolism laboratory tests at 12 months; breastfeeding and side effects at 6-13 weeks, 6 months, and 12 months; and EQ-5D-5L health and social care resource use and costs at 6-13 weeks, 6 months, and 12 months 3. Study conduct related outcomes: protocol deviations, issues with randomisation, monitoring findings, and any specific requests for support from healthcare professionals at the end of the study	—

Measure

Time frame

1. Acceptability outcomes: participants’ views on the study and the intervention at 6-13 weeks and 12 months, and healthcare professionals’ views on the barriers to recruitment, adherence and retention at the end of the study 2. Clinical and economic outcomes: maternal dysglycaemia, insulin metabolism laboratory tests at 12 months; breastfeeding and side effects at 6-13 weeks, 6 months, and 12 months; and EQ-5D-5L health and social care resource use and costs at 6-13 weeks, 6 months, and 12 months 3. Study conduct related outcomes: protocol deviations, issues with randomisation, monitoring findings, and any specific requests for support from healthcare professionals at the end of the study

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Countries

England, United Kingdom

Outcome results

None listed