Diabetic pregnancy Nutritional, Metabolic, Endocrine Diabetes mellitus arising in pregnancy
Conditions
Interventions
Current interventions as of 14/02/2012:
Subsequent to recruitment the diabetics (type 2 and gestational) and healthy non-diabetic controls will be randomly assigned to the treatment or the placebo gro
Sponsors
Newham University Hospital NHS Trust (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 14/02/2012: 1. Pregnant women aged 17-45 years old without any medical condition 2. Pregnant women aged 17-45 years old with diabetes (type 2 diabetes or gestational diabetes) Previous inclusion criteria: 1. Pregnant women with or without diabetes (type 1, type 2, gestational diabetes) 2. Eligible age: 17 - 40 years 3. Control subjects without diabetes
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 21/06/2013: 1. Pregnancy with more than one foetus 2. Known major foetal anomaly 3. Current or planned corticosteroid therapy 4. Asthma requiring medication 5. Current or planned beta-adrenergic therapy 6. Chronic medical conditions such as HIV/AIDS, kidney disease, or congenital heart disease 7. Hematologic or autoimmune disease such as sickle cell disease, other hemoglobinopathies, lupus, or antiphospholipid syndrome 8. Previous or planned tocolytic therapy to induce labour or increase contraction strength Previous exclusion criteria until 21/06/2013: 1. Smokers 2. History of stillbirth or foetal death 3. Pregnancy with more than one foetus 4. Known major foetal anomaly 5. Current or planned corticosteroid therapy 6. Asthma requiring medication 7. Current or planned beta-adrenergic therapy 8. Chronic hypertension requiring medication within 6 months of or during pregnancy 9. Chronic medical conditions such as HIV/AIDS, kidney disease, or congenital heart disease 10. Hematologic or autoimmune disease such as sickle cell disease, other hemoglobinopathies, lupus, or antiphospholipid syndrome 11.Maternal or foetal conditions likely to require preterm delivery, such as pre-eclampsia, preterm labour, or intrauterine growth retardation 12. Previous or planned tocolytic therapy to induce labour or increase contraction strength Previous exclusion criteria until 14/02/2012: 1. Smokers 2. History of stillbirth or foetal death 3. Pregnancy with more than one foetus 4. Known major foetal anomaly 5. Asthma requiring medication 6. Current or planned beta-adrenergic therapy 7. Chronic hypertension requiring medication within 6 months of, or during, pregnancy 8. Chronic medical conditions such as HIV/AIDS, kidney disease or congenital heart disease 9. Haematologic or autoimmune disease such as sickle cell disease 10. Other haemoglobinopathies 11. Lupus or antiphospholipid syndrome 12. Maternal or foetal conditions likely to require preterm delivery, such as pre-eclampsia, or intrauterine growth retardation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure(s) as of 14/02/2012 1. Maternal and foetal (cord) membrane lipid fatty acid levels at delivery Previous primary outcome measure(s) 1. Corrects the membrane lipid abnormality in diabetic mothers and their neonates | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure(s) as of 14/02/2012 1. Foetal body fat distribution 2. Placental lipid fatty acids composition and expression of placental fatty acid binding and transporter proteins Previous secondary outcome measure(s) 1. Enhances insulin sensitivity in women with gestational diabetes 2. Upregulates placental fatty acid-binding and -transporter proteins and their mRNAs | — |
Countries
United Kingdom
Outcome results
None listed