- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07289204
FinnDiane LifeOne Study - Impact of Ageing on People With Type 1 Diabetes (LifeOne)
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Helsinki, Finland
- HUS Helsinki University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Participants of the Finnish Diabetic Nephropathy Study
- Type 1 diabetes
- With age above 65 years
- Informed consent provided
Exclusion Criteria:
- Age below 65 years
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Type 1 diabetes
Participants of the Finnish Diabetic Nephropathy Study, age above 65 years.
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Controls
Age above 65 years, no diabetes with insulin therapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Healthy ageing in people with type 1 diabetes mellitus
Time Frame: From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.
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Key Characteristics and Clinical Implications of healthy aging in individuals with type 1 diabetes mellitus
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From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Physical capacity
Time Frame: From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.
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The locomotor domain of the individual's intrinsic capacity, based on the framework for healthy ageing.
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From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.
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Cognitive function
Time Frame: From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.
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The cognitive domain of the individual's intrinsic capacity, based on the framework for healthy ageing.
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From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.
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Psychological well-being
Time Frame: From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.
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The psychological domain of the individual's intrinsic capacity, based on the framework for healthy ageing.
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From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.
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Vitality
Time Frame: From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.
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The vitality domain of the individual's intrinsic capacity, based on the framework for healthy ageing.
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From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.
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Sensory function
Time Frame: From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.
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The sensory domain of the individual's intrinsic capacity, based on the framework for healthy ageing.
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From initial enrollment in the FinnDiane Study until the LifeOne follow-up visit after three to five years.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUS/4387/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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