Gestational Diabetes Mellitus Clinical Trial
Official title:
The Effect of a Low GI Diet on Maternal and Neonatal Markers of Glycaemic Control and Postpartum Diabetes Risk SUBSTUDY The Effect of a Low GI Diet on Postpartum Markers of Oxidation in Breast Milk of Women With Gestational Hyperglycaemia
MAIN STUDY: Low glycaemic index (GI) diets are recommended by the Canadian Diabetes
Association for treating type 1 and 2 diabetes mellitus (DM), but the role of GI in the
management of gestational diabetes(GDM)is not yet clear. The main purpose of this study is
to determine the effect of a low GI diet on blood sugar control in women with GDM. The
effect of a low GI diet on maternal oxidative stress, pregnancy and delivery outcomes and
markers of risk for diabetes after birth in both the mother and baby will also be assessed.
SUB-STUDY: The main purpose of the sub-study is to determine if the breast milk (BM) of
women with GDM consuming a low GI diet will have a higher antioxidant capacity than the BM
of women receiving a medium-high GI diet (control/standard care). The effect of a low
glycaemic index diet on maternal dietary intake of specific nutrient-antioxidants (i.e.
vitamin C, E, and beta-carotene) (prenatal and postpartum) and concentration of vitamin C,
E, and beta-carotene in participants' transitional and mature BM will also be assessed. The
ORAC (Oxygen radical absorbance capacity) assay will be used to assess overall antioxidant
capacity. The antioxidant capacity of BM in women with GDM will also be compared with that
of women without GDM.
Hypotheses:
MAIN: The use of low-GI foods in the management of GDM reduces postprandial BG and oxidative
stress; thereby reducing maternal and infant perinatal complications.
SUB-STUDY: Breast milk (BM) of women with GDM consuming a low GI diet will have higher BM
antioxidant than women receiving the medium to high GI diet. BM of women with GDM will have
lower antioxidant capacity than that of women without GDM.
MAIN STUDY: Use of low GI education is currently accepted by the Canadian Diabetes
Association in treatment of type 1 and 2 DM, but is not included in the clinical practice
guidelines(CPG) for management of GDM. Data collected to date support use of low GI in
treatment of GDM, but more data are needed to influence CPG. In this study the effect of a
low GI diet on maternal and neonatal markers of glycaemic control and postpartum diabetes
risk in mother and baby will be determined. This study will also assess the role that
maternal oxidative stress may play in this relationship.
Hypothesis: The use of low-GI foods in the management of GDM reduces postprandial BG and
oxidative stress; thereby reducing maternal and infant perinatal complications.
SUB-STUDY: Breast milk (BM) is accepted as the optimal source of nutrition for infants. A
wealth of literature on BM composition exists. This work includes measurement of
antioxidants in BM. Women diagnosed with gestational hyperglycaemia have decreased
antioxidant capacity in comparison to normoglycaemic pregnant women. A direct relationship
exists between postprandial glycaemic response and oxidative stress. Low GI carbohydrate is
converted to blood glucose (BG) more slowly than medium to high GI carbohydrate
Hypotheses: Breast milk (BM) of women with GDM consuming a low GI diet will have higher BM
antioxidant than women receiving the medium to high GI diet. BM of women with GDM will have
lower anti-oxidant capacity than that of women without GDM.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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