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临床试验/NCT07289204
NCT07289204Enrolling By Invitation不适用

FinnDiane LifeOne Study - Impact of Ageing on People With Type 1 Diabetes

Helsinki University Central Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年1月29日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
400
试验地点
1
主要终点
Healthy ageing in people with type 1 diabetes mellitus

研究概览

简要总结

Healthy aging refers to functional ability that enables well-being in older individuals. The focus thus shifts from chronological age to functional capacity and the individual's own experience of well-being. Type 1 diabetes is a chronic condition characterized by elevated blood glucose levels, which increases the risk of cardiovascular diseases and premature death. However, the life expectancy of individuals with type 1 diabetes has significantly improved due to advances in diabetes care.

There is limited research on aging with type 1 diabetes, and this study is at the forefront of addressing this gap by examining aging-and especially healthy aging-in type 1 diabetes from multiple perspectives. The goals are to investigate how individuals with type 1 diabetes age and what their functional capacity is compared to individuals without insulin-treated diabetes. The other aim is to identify factors in midlife that predict healthy aging in people with type 1 diabetes.

详细描述

Ageing with type 1 diabetes is an emerging challenge due to improved life-expectancy of people with type 1 diabetes. While those who survive to an older age are considered survivors, the many years with type 1 diabetes and the chronic dysglycaemia inevitably also has negative health impacts on people living with this chronic disease. With scarce research in this area, ageing in type 1 diabetes has been identified as a research gap.

With this study, the aim is to assess the impact of ageing in people with type 1 diabetes via thorough characterization of older adults with type 1 diabetes, in comparison to matched controls. This will be accomplished through a comprehensive assessment of the participants' metabolic profile, body composition, vascular health, autonomic function, and a geriatric assessment focusing on the functional ability of the participants. In addition, this study will assess what type of challenges older adults with type 1 diabetes face regarding self-management, diabetes care, and daily life.

This study is a sub-study of the national Finnish Diabetic Nephropathy Study, initiated in 1997 and including adults with type 1 diabetes. Individuals over 65 living in the Helsinki capital area will now be invited for a regular FinnDiane study visit, as well as an additional visit for a geriatric assessment. The aim is to study 300 FinnDiane study participants and recruit a minimum of 100 matched controls. This cohort will be prospectively followed with a revisit after three to five years.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants of the Finnish Diabetic Nephropathy Study
  • Type 1 diabetes
  • With age above 65 years
  • Informed consent provided

排除标准

  • Age below 65 years

结局指标

主要结局

Healthy ageing in people with type 1 diabetes mellitus

时间窗: From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.

Key Characteristics and Clinical Implications of healthy aging in individuals with type 1 diabetes mellitus

次要结局

  • Physical capacity(From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.)
  • Cognitive function(From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.)
  • Psychological well-being(From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.)
  • Vitality(From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.)
  • Sensory function(From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.)

研究者

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

Lena M. Thorn

Associate professor, Head physician, Helsinki University Hospital

Helsinki University Central Hospital

研究点 (1)

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