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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 8
- 主要终点
- MAIN STUDY: Percentage of postprandial self monitored blood glucose (SMBG) values within the target range
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •diagnosed with gestational diabetes mellitus (GDM) or impaired glucose tolerance of pregnancy (IGTP) according to Canadian Diabetes Association (CDA) criteria
- •being followed within DIP (one of 4 sites)
- •willing and able to give informed consent
- •willing and able to comply with the study protocol
排除标准
- •with acute or chronic illness other than GDM or IGTP or use of drug (other than insulin) which may affect carbohydrate metabolism, gastrointestinal function or carbohydrate digestion (i.e. crohn's disease, HIV/AIDS, liver disease, kidney disease etc.).
- •known to have type 1 or type 2 DM prior to pregnancy
- •known multi-fetal pregnancy at enrolment
- •≥ 33 weeks' gestation
- •prescribed oral anti-hyperglycaemic medication
- •insurmountable language barriers
- •SUB-STUDY control group (women without GDM) Same as for Main study except absence of GDM
结局指标
主要结局
MAIN STUDY: Percentage of postprandial self monitored blood glucose (SMBG) values within the target range
时间窗: From randomization to delivery
SMBG values are obtained 4 times daily (1 fasting and 3 postprandial) throughout the study from the randomization to delivery. The endpoint is a single value for each participant - namely the percentage of all the postprandial SMBG values within the target range recommended by the Canadian Diabetes Association (5.0 to 6.6 mmol/L)
SUB-STUDY (n=75): Oxygen Radical Absorbance Capacity (ORAC) (Antioxidant Capacity) of transitional and mature breast milk.
时间窗: 1 week and 8 weeks postpartum
Breast milk samples (25 mL) will be collected 1 week and 8 weeks after birth from a complete breast milk collection. Measures will be compared between and within groups.
次要结局
- MAIN STUDY: Mean postprandial glucose(From randomization to delivery)
- MAIN STUDY: Post-partum serum glucose concentration 2 hours after consumption of 75g oral glucose (2hrPC serum glucose).(6-8 weeks after delivery)
- MAIN STUDY: Insulin prescription incidence(From randomization to delivery)
- MAIN STUDY: Mean post-breakfast glucose(From randomization to delivery)
- MAIN STUDY & SUB-STUDY (n=75): Maternal dietary intake(From randomization to 6- 8 weeks post-partum)
- MAIN STUDY: Change in maternal blood pressure and resting pulse from randomization to 4 weeks(Change from randomization to 4 weeks.)
- MAIN STUDY: Change in LDL oxidation at 4 weeks(Change from randomization in LDL oxidation at 4 weeks.)
- MAIN STUDY: Change in Oxygen Radical Absorbance Capacity (ORAC) of plasma at 4 weeks(Change from randomization to 4 weeks)
- MAIN STUDY: Incidence of post-partum impaired glucose tolerance(6-8 weeks after delivery)
- MAIN STUDY: Maternal weight gain(From pre-pregnancy to delivery: up to 9 months)
- MAIN STUDY: Rate of maternal weight gain(From randomization to delivery)
- MAIN STUDY: Length of time between delivery and maternal breast fullness(Time after delivery)
- MAIN STUDY: Change in full lipid profile at 4 weeks(Change in full lipid profile of plasma from baseline at 4 weeks)
- MAIN STUDY: Change in participant knowledge of GI from baseline to 6-8 weeks after delivery(Change in GI knowledge from randomization to 6-8 weeks after delivery)
- MAIN STUDY: Percentage of self-monitored fasting glucose values within the target range(From randomization to delivery)
- MAIN STUDY: Glucose variability(From randomization to delivery)
- MAIN STUDY: Mean fasting glucose(From randomization to delivery)
- MAIN STUDY: Change in c-reactive protein (CRP) at 4 weeks(Change in CRP from randomization at 4 weeks)
- SUB-STUDY (n=75): Concentration of vitamin C, E, and Beta-carotene in mature breast milk(6-8 weeks after delivery)
- MAIN STUDY: Change in infant body measurements from birth to 6-8 weeks post-partum(Change in infant body measurements from delivery to 6-8 weeks post-partum)
- MAIN STUDY: Infant APGAR score at delivery(Delivery)
- MAIN STUDY: Maternal pre-natal demographic information(Baseline)
- MAIN STUDY: Conjugated dienes post-partum(6-8 weeks after delivery)
- MAIN STUDY: Oxygen Radical Absorbance Capacity (ORAC) of venous plasma post-partum(6-8 weeks after delivery)
- MAIN STUDY: Infant birth weight(At delivery)
- MAIN STUDY: Mean post-lunch blood glucose(From randomization to delivery)
- MAIN STUDY: Mean post-dinner blood glucose(From randomization to delivery)
- MAIN STUDY: LDL oxidation 6-8 weeks after delivery(6-8 weeks after delivery)
- MAIN STUDY: Post-partum CRP(6-8 weeks after delivery)
- MAIN STUDY: Change in infant weight(Change in infant body weight from birth to 6- 8 weeks)
- MAIN STUDY: Change in ultrasound measurements from randomization to delivery.(Change from randomization to delivery)
- MAIN STUDY: Maternal height at baseline(Baseline)
- MAIN STUDY: Change in maternal weight from delivery at 6-8 weeks post-partum(Difference between delivery and 6-8 weeks post-partum)
- MAIN STUDY: Full lipid profile post-partum(6-8 weeks after delivery)
- MAIN STUDY: Participant satisfaction of baseline education class(Baseline)
- MAIN STUDY: Participant knowledge of GI at baseline(Baseline)
- MAIN STUDY: Post-partum fasting serum glucose(6-8 weeks after delivery)
- MAIN STUDY: Incidence of post-partum diabetes mellitus(6-8 weeks after delivery)
- SUB-STUDY (n=75): Concentration of vitamin C, E, and Beta-carotene in transitional breast milk(1 week after delivery)
- MAIN STUDY: Maternal blood pressure and resting pulse at 6-8 weeks post-partum(6-8 weeks after delivery)
- MAIN STUDY: Infant waist circumference at 6-8 weeks(6-8 weeks after delivery)
- MAIN STUDY: Maternal medical complications from baseline to 6-8 weeks post-partum(Baseline to 6-8 weeks after delivery)
- MAIN STUDY: Infant feeding practices(6-8 weeks after delivery)
- MAIN STUDY: Infant demographics(Delivery to 6-8 weeks postpartum)
- MAIN STUDY: Maternal medical history(Baseline)
- MAIN STUDY: Maternal post-partum socio-demographic data related to infant feeding practices(6-8 weeks after delivery)
- MAIN STUDY: Change in conjugated dienes at 4 weeks(change from baseline to 4 weeks.)
- MAIN STUDY: Change in participant opinion on availability and acceptability of study diet foods(Change in opinion from 2 weeks to 6-8 weeks after delivery)
- MAIN STUDY: Change in incidence and severity of symptoms from baseline to 6-8 weeks postpartum(Change from baseline to 6-8 weeks postpartum)
- MAIN STUDY: Difference in dietary GI between study groups.(From baseline to 6-8 weeks after delivery)
- MAIN STUDY: Change in behaviour from baseline (pre-class) to 6-8 weeks after delivery.(Change in behaviour from baseline (pre-class) to 6-8 weeks after delivery)
研究者
Thomas Wolever
Professor
University of Toronto