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临床试验/NCT02384148
NCT02384148Unknown不适用

Measure and Comparison of Molecular Circadian Clock Properties in Healthy Subjects, Obese and Type 2 Diabetic Patients.

University Hospital, Geneva1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Difference of period length

研究概览

简要总结

The investigators aimed to characterize human circadian clockwork in healthy individuals in comparison to obese and type 2 diabetic subjects, employing the noninvasive experimental approach allowing the study of circadian profile in human individuals.

详细描述

The investigators specifically aim to obtain and analyze the circadian profile of skin fibroblasts from healthy, obese and T2D subjects. Does circadian oscillator profile and its parameters (phase, period and amplitude) will differ between healthy individuals and obese/ T2D patients? Skin biopsy will be performed in order to collect and culture skin fibroblast cells.

In vivo bioluminescence recording will be performed in primary human skin fibroblast cells. The profiles obtained from 10 subjects in each group will be compared to their healthy counterparts.

Bmal1and Per2 are clock genes. Lentiviral transduction of Bmal1-luciferase or Per2-luciferase in fibroblasts allow observation of circadian oscillations using bioluminescence assay. Phase, period length and amplitude are used to characterize the circadian rhythm.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 20-80
  • consent obtained

排除标准

  • neoplasia
  • inflammatory disease
  • allergy to lidocaine

结局指标

主要结局

Difference of period length

时间窗: 5 days

Period length will be calculated from oscillation profiles of Bmal1-luciferase or Per2-luc luciferase.

次要结局

  • Difference of amplitude(5 days)

研究者

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

Charna Dibner

phD

University Hospital, Geneva

研究点 (1)

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