None listed
Conditions
Brief summary
Gestational diabetes (GD) is a form of diabetes which occurs during pregnancy, and generally resolves after delivery. It is diagnosed as high blood glucose during pregnancy, and affects around 5–10% of all pregnancies in Australia. Recent changes to diagnostic criteria along with an increasingly obese population and older age at which women have their first child, mean the prevalence of GD is rapidly rising. Pregnancy is known to be an insulin-resistant state, and failure to adequately compensate for this inherent insulin resistance through increased insulin secretion results in hyperglycaemia. Whilst the precise mechanisms behind this insulin resistant state are unclear, there is increasing evidence that inflammation of adipose tissue is associated with GD development. Pregnancy is characterized by adipose tissue remodeling and growth, which is modulated by inflammatory markers. However, higher levels of inflammatory markers such as IL-6 and TNF-a, and lower levels of adiponectin are associated with the development of GD. Docosahexaenoic Acid (DHA) is an omega-3 polyunsaturated fatty acid (n-3PUFA) that is critical to the neural development of the foetus during pregnancy, and may be beneficial to adipose tissue functioning during pregnancy. Pregnancies complicated by type 2 diabetes and GD are associated with a decline in erythrocyte DHA in late pregnancy when compared with normoglycaemic pregnancies. This fall can be ameliorated by DHA supplementation during pregnancy. Supplementation of n-3PUFAs in pregnancies affected by GD confers beneficial effects on insulin resistance when compared with control groups Furthermore, supplementation of EPA + DHA from weeks 10-16 of pregnancy until term results in reduced expression of IL-6, IL-8 and TNF-a in both adipose and placental tissue. The improved insulin sensitivity and adipokine profile and reduced levels of inflammatory markers suggest improved adipose tissue function in response to n-3PUFA supplementation, which could reduce the risk of developing GD. To date, research investigating the relationship between n-3PUFAs and GD as an outcome have not reported a relationship. However, supplementation in these trials commenced later in the second trimester, from 17 weeks’ gestation, with the majority not commencing until 24 weeks gestation. We postulate this is too late in pregnancy as GD has often become apparent by this point. No research has reported the effect of an n-3PUFA intervention in early pregnancy on insulin resistance, adipokines and markers of inflammation. We hypothesize that DHA supplementation supports healthy adipose tissue development and functioning during pregnancy, and this in turn reduces the risk of developing gestational diabetes. The aim of the current study is to determine the effect of a low-dose DHA-enriched n-3PUFA supplement on measures of insulin resistance, adipokine profile and inflammatory markers from early pregnancy in women at high risk of developing GD.
Interventions
2 x 1g fish oil capsules each day (each capsule containing 60mg eicosapentaenoic acid and 430mg docohexaenoic acid) from ~ 14 weeks gestation until 34 weeks gestation. Adherence to trial protocol will be assessed using a capsule log, return capsule count, and erythrocyte fatty acid composition.
Sponsors
The University of Newcastle
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
<14 weeks pregnant Aged 18-40 Any one of the following: a) PAPP-A between 0.3 and 0,6 MoM in their Nuchal Translucency Scan b) previous history of gestational diabetes c) at risk of developing gestational diabetes according to Health pathway criteria
Exclusion criteria
BMI greater than 45kg/m2 Any incidence of ongoing bleeding beyond 8 weeks gestation in the current pregnancy Is on anti-coagulant therapy or known to have clotting disorders Known to be pregnant with multiples Lactating Established diabetes prior to pregnancy or currently taking anti-diabetic medications Being diagnosed with gestational diabetes in this pregnancy prior to enrolment in the study Known allergies to seafood or corn Currently on medication with Aspirin and Warfarin Has significant current gastro-intestinal disease Is incapable of giving informed consent History of new investigational drug three months prior to this trial Currently consuming more than 200g oily fish per week or taking supplements delivering 150mg or more of DHA/day Unable to fast for 10hr before obtaining blood sample
Outcome results
None listed