Effect of Extra Virgin Olive Oil Addition in the Diet of Women With Gestational Diabetes Mellitus (OLIDIAG)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- maternal triglyceridemia
研究概览
简要总结
Gestational diabetes mellitus (GDM) is associated to adverse maternal and neonatal outcomes. The aim of this study is to address whether the addition of extra virgin olive oil to the diet of women with GDM improves maternal triglyceridemia and reduces insulin requirement and diagnosis of diabetes at postnatal reclassification.
详细描述
This study is a randomized trial in which 1200 pregnant women at GDM diagnosis from 16 health care centers will be recruited and randomized in two parallel arms: 1 World Health Organization (WHO)-diet supplemented with 3 tablespoons of Extra Virgin Olive Oil (Intervention Group, n=600); 2. WHO-diet with no Extra Virgin Olive Oil supplementation (Control Group, n=600). Expected results: the investigators expect that the intervention will contribute to improve maternal lipid profile, reduce insulin requirement and reduce maternal diagnosis of diabetes at postpartum reclassification. Thus, this study is expected to identify maternal beneficial effects of this dietary intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
Data analysis will be masked
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •GDM (diagnosis criteria of the Latin American Society of Diabetes (ALAD) and Argentine Society of Diabetes (SAD): Fasting plasma glucosa > 100 mg/dl, p75 oral glucose tolerance test-2 h plasma glucose > 140 mg/dl)
排除标准
- •Multiple pregnancy
- •Pregestational diabetes (type 1 or type 2)
- •Bariatric surgery
- •Infectious diseases
研究组 & 干预措施
Dietary addition of extra virgin olive oil
WHO diet with a daily addition of extra virgin olive oil
干预措施: Extra Virgin Olive Oil Addition (Dietary Supplement)
No addition of extra virgin Olive Oil
WHO diet
结局指标
主要结局
maternal triglyceridemia
时间窗: term pregnancy
triglycerides in mg/dl
number of participants with insulin requirement
时间窗: term pregnancy
insulin use
maternal weight gain
时间窗: change from prepregnancy weight to term pregnancy weight
gestational maternal weight gain in kg
次要结局
- number of participants with diabetes at postpartum(six weeks postpartum)