Gestational diabetes mellitus Pregnancy and Childbirth Diabetes mellitus arising in pregnancy
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Circulating concentration of fasting total and intact proinsulin at 16-18 weeks gestation | — |
Secondary
| Measure | Time 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