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Proinsulin in gestational diabetes mellitus

Proinsulin in the diagnosis and risk stratification of gestational diabetes mellitus

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN16416602
Enrollment
200
Registered
2017-10-11
Start date
2017-10-16
Completion date
Unknown
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational diabetes mellitus Pregnancy and Childbirth Diabetes mellitus arising in pregnancy

Interventions

This study will involve three visits for participants, at different stages of gestation. Visit 1 (16-18 weeks gestation): participants will be asked to attend at 16-18 weeks gestation, having fasted o

Sponsors

Abertawe Bro Morgannwg University Health Board
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Pregnant women at least 18 years of age at 16-18 weeks gestation with any one of the following: 1. BMI >30kg/m2 2. Previous macrosomic baby (>4.5kg) 3. Previous gestational diabetes mellitus 4. Family history of type 2 diabetes mellitus (first degree relative with diabetes)

Exclusion criteria

Exclusion criteria: 1. Subjects unable or unwilling to sign informed consent 2. Known previous diabetes mellitus or treatment with metformin 3. Known chronic infection like Hepatitis or HIV or chronic kidney, liver or heart disease 4. Previous bariatric surgery

Design outcomes

Primary

MeasureTime frame
Circulating concentration of fasting total and intact proinsulin at 16-18 weeks gestation

Secondary

MeasureTime frame
1. Diagnosis of gestational diabetes mellitus as established by glucose measurements following an oral glucose tolerance test at 24-28 weeks 2. Need for insulin during the pregnancy obtained from clinical notes 3. Relationship between individual risk factors and proinsulin for the development of gestational diabetes mellitus, measured using logistic regression at 16-18 weeks

Countries

United Kingdom, Wales

Contacts

Public ContactSarah Dowrick
sarah.c.dowrick@swansea.ac.uk+44 (0)1792 602590

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 23, 2026