NCT03579667已完成不适用
Lipid Profile and Weight After Pregnancy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in markers of lipid- and glucose metabolism between visits
研究概览
简要总结
A randomized controlled trial aiming to investigate the effects of diet behavior intervention postpartum on body weight and lipid and metabolite profile in overweight and obese women in Oslo, Norway
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
- •Women admitted to Adipol, Oslo University Hospital, Norway (outpatient clinic for women with overweight or obesity during pregnancy)
排除标准
- •Twin birth,
- •Non-Norwegian speaking
结局指标
主要结局
Changes in markers of lipid- and glucose metabolism between visits
时间窗: Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
Measured in mmol/l: total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides and glucose In percentage: HbA1c In pmol/l: insulin.
Changes in body weight (kg) between visits.
时间窗: Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
Measured in light clothing without shoes. Together with measured height (m) will be used to calculate Body Mass Index.
次要结局
- Changes in PBMC (peripheral blood mononuclear cell) gene expression levels of markers of inflammation and lipid metabolism between visits.(Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)])
- Changes in lipid subclasses (mmol/l), lipoprotein size (nm) and apolipoproteins between visits(Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)])
- Changes in circulating inflammation markers such as cytokines, high sensitivity C-Reactive Protein, C-Reactive Protein (CRP) and microCRP between visits.(Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)])
- Changes in plasma metabolomics such as lactate, pyruvate, citrate and amino acids between visits.(Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)])
- Changes in blood pressure, diastolic and systolic between visits(Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)])
- Changes in waist and hip (cm) circumference between visits(Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)])
- Changes in body composition (fat free mass in kg and fat mass in kg) between visits.(Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)])
- Changes in hemostatic markers such as plasminogen activator inhibitor-1 (PAI-1) antigen and von Willebrand factor (vWF) between visits.(Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)])
- Changes in hormones such as prolactin, estradiol, progesterone between visits(Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)])
- Changes in markers of micronutrient status such as Hb and vitamin D between visits.(Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)])
- Changes in dietary intake and Food Choice by food frequency questionnaire at each of the 3 visits(Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)])
- Changes in physical activity between visits.(Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)])
研究者
Hilde Kristin Brekke
Professor
University of Oslo
研究点 (2)
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