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临床试验/NCT02048839
NCT02048839已完成不适用

Long-term Effects of Lifestyle Intervention During Pregnancy in High Risk Women and in Their Offspring - Role of Environmental, Genetic and Epigenetic Factors

Helsinki University Central Hospital1 个研究点 分布在 1 个国家目标入组 680 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
680
试验地点
1
主要终点
Type 2 Diabetes

研究概览

简要总结

SUBJECTS:

All participants in the RADIEL-study (2008-2011) who delivered (n=535), will be invited to this follow-up study, with their children (age 3-5 years) and the father. The investigations are carried out during two separate visits. The father receives mail questionnaires

OVERALL OBJECTIVES:

  1. To determine the long-term effectiveness of a lifestyle intervention in high risk women and their offspring a in reducing the incidence of T2DM and cardiovascular disease and their risk factors b in preventing obesity c on biomarkers d on genetic and epigenetics markers .
  2. To study the association between maternal diet during pregnancy and metabolic markers in the offspring at age 3-5 years.
  3. To study the association between maternal exercise habits during pregnancy and metabolic markers in the offspring at age 3-5 years.
  4. To study the association between maternal a) glucose-insulin metabolism b) lipid metabolism c) adipoinsulinar axis and d) inflammatory markers and birth size and later health outcomes in the mothers and their offspring.
  5. To study the association between gut microbiota and markers of offspring health
  6. To study associations between offspring cardiovascular morphology/function, offspring body size/composition, and maternal cardiovascular risk
  7. To study the cost effectiveness of the intervention.

METHODS:

Maternal measurements

  1. Height, weight, waist and hip circumference
  2. Blood pressure, pulse
  3. Body fat percentage
  4. Blood tests e.g. markers of glucose metabolism and lipids, vitamin D, Calcium and bone markers, DNA sample and inflammation markers
  5. Fecal and hair samples
  6. Diurnal salivary cortisol assessment
  7. Background questionnaire: socioeconomic and health-related background
  8. Health-related quality of life (15-D).
  9. 3-day food diary and exercise diary
  10. ArmBand (acceleration sensor), assessment of physical activity and sleep for 7 days
  11. Psychological questionnaires
  12. Pulse wave velocity (PWV) will be assessed
  13. Advanced glycation endproducts - a marker of cardiovascular health will be assessed
  14. Dental and oral health
  15. Bone health
  16. VHRU of arterial structure

Paternal measurements

  1. Background questionnaire (incl. height, weight, age)
  2. DNA-sample (buccal)
  3. 3-day food diary
  4. Psychological questionnaires
  5. Physical activity questionnaire (12 months)

Measurements of children

  1. Body weight, height, blood pressure, pulse
  2. Body fat percentage
  3. Psychological questionnaires
  4. Food and physical activities diaries
  5. ActiGraph, assessment of physical activity and sleep for 7 days
  6. Blood samples e.g. glucose- and insulin metabolism, lipids, vitamin D and calcium metabolism, DNA-sample and samples for inflammation markers
  7. Fecal, urine and hair samples
  8. A copy of child welfare center card (e.g. data on growth, immunizations, health)
  9. Endothelial function and pulse wave velocity (PWV)
  10. Bone health with peripheral CT
  11. Heart structure and function
  12. VHRU of arterial structure

TIMETABLE

Follow up starts in January 2014, and will continue until 2018. Data analysis starts in 2017 and results will be reported from 2018 onwards in international peer-reviewed journals.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
3 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • all study subjects form Radiel intervention study, who delivered a baby

排除标准

  • 未提供

结局指标

主要结局

Type 2 Diabetes

时间窗: 3-5 years post partum

次要结局

  • Metabolic syndrome and cardiovascular morbidity(3-5 years post partum)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Saila Koivusalo

MD PhD

Helsinki University Central Hospital

研究点 (1)

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