跳至主要内容
临床试验/NCT02868905
NCT02868905Unknown不适用

Identification of Epigenetic Markers Common to Obesity and Alzheimer's Disease in Women - Pilot Study

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2016年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
160
试验地点
1
主要终点
Methylation of CpG islands in genomic DNA and in 4 target genes involved in AD (APP, SorLA/LR11, BACE1, LRP) in obese and AD subjects

研究概览

简要总结

The purpose of this study is to compare average methylation of epigenetic markers on genomic DNA and some genes (APP, BACE, LRP, SorL1) involved in cerebral amyloid homeostasis:

  • Of obese young adults and healthy young adults
  • Of obese young adults and individuals affected by Alzheimer's disease (AD) having been obese at young adult age (<50 years old) or individuals affected by Alzheimer's disease (AD) having never been obese.

The secondary purpose is to determine if there is an association between the frequency of these epigenetic markers and elements associated to the metabolic syndrome (lipidic and glycemic analysis, leptinemia, inflammation markers) and clinical ones (visceral fat mass, body mass index) in young adults.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
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

入选标准

  • 18-50 year old women, age- (10 years) and sociocultural-matched with group 2
  • Non obese and never been obese
  • 18.5 < BMI < 25
  • Folstein MMS > 27
  • Informed consent
  • Affiliation to social security plan
  • 18-50 year old women, age- (10 years) and sociocultural-matched with group 1
  • Waist size > 88cm
  • 30 < BMI < 45
  • Insulin-resistant patients (Insulin resistance index, HOMA-IR > 3.8)
  • Obesity onset during childhood (pre-puberty period)
  • Folstein MMS > 27
  • Informed consent
  • Affiliation to social security plan
  • >60 year old women, age- (10 years) matched with group 4
  • No obesity history (18.5 ≤ BMI < 25 at adult age)
  • Sporadic forms of mild to moderate AD with demonstration of AD physiopathologic process according to new recommendations of 2011 of National Institute on Aging and Alzheimer's Association on diagnostic guidelines for Alzheimer's disease
  • 15< Folstein MMS ≤ 26
  • Informed consent
  • Affiliation to social security plan
  • >60 year old women, age- (10 years) matched with group 3
  • Obesity history (BMI > 30 at least one time at adult age)
  • Sporadic forms of mild to moderate AD with demonstration of AD physiopathologic process according to new recommendations of 2011 of National Institute on Aging and Alzheimer's Association on diagnostic guidelines for Alzheimer's disease
  • 15 < Folstein MMS ≤ 26
  • Informed consent
  • Affiliation to social security plan

排除标准

  • Patient under guardianship, curatorship or judicial protection
  • Folate supplementation
  • Diabetic or glucose intolerant subjects
  • Present participation to another study with neuropsychological evaluation and/or drug administration
  • Pregnant women
  • Groups 2,3 and 4:
  • Patient under guardianship, curatorship or judicial protection
  • Folate supplementation
  • Present participation to another study with neuropsychological evaluation and/or drug administration
  • Pregnant women
  • Obese or overweight patients (BMI>25)

结局指标

主要结局

Methylation of CpG islands in genomic DNA and in 4 target genes involved in AD (APP, SorLA/LR11, BACE1, LRP) in obese and AD subjects

时间窗: day 0

次要结局

  • body mass index(day 0)
  • visceral fat mass level(day 0)
  • leptinemia by ELISA(day 0)
  • insulinemia by ELISA(day 0)
  • glycemia(day 0)
  • triglyceridemia(day 0)
  • HDL cholesterol level in blood(day 0)
  • Reactive C protein level in blood(day 0)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Identification of Epigenetic Markers Common to... | 临床试验