None listed
Conditions
Brief summary
Several studies have shown that vitamin B12 status during pregnancy is of major importance to health of mother and her offspring. As vitamin B12 deficiency poses risks to both the expectant mother and foetus it is vital for pregnant women, who are at risk of vitamin B12 deficiency, to undergo appropriate monitoring and to have adequate vitamin B12 supplementation. We hypothesized that the metformin use for treatment of gestational diabetes will increase the risk for the development of vitamin B12 deficiency. Study participants were assigned to their study treatments (diet, insulin, metformin or metformin and insulin) according to the required standard of care during their pregnancies. Pregnant women underwent measurements of total vitamin B12 levels and holotranscobalamin levels, folate, FBC with MCV and MCH. The vitamin B12 levels were measured at the first visit to the gestational diabetes clinic, after 30 weeks of pregnancy and additionally after 4-6 weeks of treatment with metformin. The present study will additionally examine the antenatal and postnatal outcomes of pregnancies in patients with vitamin B12 deficiency, which we will determine based on the information from patients’ medical records.
Interventions
Pregnant women with gestational diabetes underwent measurements of total vitamin B12 levels and holotranscobalamin levels (HoloTC) as a marker of functional vitamin B12 status [1]. In addition, all women underwent measurements of folate, FBC with MCV and MCH as per current standard of care in gestational diabetes clinics. The vitamin B12 levels was measured at the first visit to the gestational diabetes clinic, after 30 weeks of pregnancy and additionally after 4-6 weeks of treatment with me
Pregnant women with gestational diabetes underwent measurements of total vitamin B12 levels and holotranscobalamin levels (HoloTC) as a marker of functional vitamin B12 status [1]. In addition, all women underwent measurements of folate, FBC with MCV and MCH as per current standard of care in gestational diabetes clinics. The vitamin B12 levels was measured at the first visit to the gestational diabetes clinic, after 30 weeks of pregnancy and additionally after 4-6 weeks of treatment with metformin. Study participants were assigned to their study treatments (diet, insulin, metformin or metformin and insulin) and their clinical progress was monitored as per standard medical care. The data collection from studied participants will start from their first visit to the gestational diabetes clinic until 7 days post-partum. For the purpose of the analysis patients will be split based on their treatment regimen into the following groups: 1. Treated with metformin <1000 mg 2. Treated with metformin 1000mg-2000 mg 3. Treated with diet and lifestyle changes (control group) 4. Treated with insulin 5. Treated with metformin and insulin We will assess the outcome of pregnancies in patients with vitamin B12 deficiency, which we will determine based on the following information from medical records: 1. Gestational age at delivery 2. Duration of metformin treatment – to elucidate the average duration of metformin treatment leading to the vitamin B12 deficiency 3. Impact of vitamin B12 status on control of GDM – to assess whether deficiency/ insufficiency of vitamin B12 levels was associated with poorer control of GDM 4. Birth weight of neonate 5. Rates of pregnancy complications for: A Gestational hypertension B. Pre¬eclampsia C. Antenatal haemorrhage D. Preterm labour E. Preterm rupture of membranes 1. Nexo, E. and E. Hoffmann-Lucke, Holotranscobalamin, a marker of vitamin B-12 status: analytical aspects and clinical utility. Am J Clin Nutr, 2011. 94(1): p. 359S-365S.
Sponsors
Sutherland Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Gestational diabetes mellitus diagnosed on oral glucose tolerance test. 2. Patient at Sutherland Hospital and St George Gestational Diabetes Clinic. 3. Valid consent
Exclusion criteria
1. Prior diagnosis of diabetes (T1DM or T2DM) 2. Diagnosis of pernicious anaemia 3. Treatment with proton pump inhibitors or H2 receptor antagonists
Outcome results
None listed