Type 2 Diabetes Mellitus as Catalyst for Alzheimer's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

202 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-05-31

Brief Summary

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In recent years, it has been observed that the type 2 diabetic patients (DM-2) have an increased risk of developing dementia, both vascular and Alzheimer's disease (AD). The term mild cognitive impairment (MCI) describes a transition state between normal cognitive function and dementia. The annual rate of conversion to dementia in MCI patients is around 15% in the general population, regardless of the presence or absence of diabetes. At present it is not possible to identify which patients with MCI are most likely to progress to AD. On this basis, the main objective of this study is to evaluate whether the presence of diabetes and or the presence of its related genes favors the conversion of MCI to AD.

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Detailed Description

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In recent years, it has been observed that the type 2 diabetic patients (DM-2) have an increased risk of developing dementia, both vascular and Alzheimer's disease (AD). The term mild cognitive impairment (MCI) describes a transition state between normal cognitive function and dementia. The annual rate of conversion to dementia in MCI patients is around 15% in the general population, ie regardless of the presence or absence of diabetes. At present it is not possible to identify which patients with MCI are most likely to progress to AD. On this basis, the main objective of this study is to evaluate whether the presence of diabetes favors the conversion of MCI to AD. We propose a case-control study comparing a group of 110 diabetic patients and a group of 110 non-diabetic patients with MCI matched by age, sex and cardiovascular risk factors. The main objective is the conversion to AD between the groups and if DM-2 is an independent risk factor. The secondary objective is to investigate whether genetic mechanisms related both to AD and DM-2 are associated with the increased risk of AD in diabetic patients. We will analyze 10 genes simultaneously associated with an increased risk of diabetes and / or its complications and AD.

Conditions

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Alzheimer´s Disease Diabetes Mellitus Type 2

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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T2D-MCI

110 MCI subjects with type 2 diabetes. There is a retrospectiv observational study. No intervention will be performed.

There is a retrospectiv observational study. No intervention

Intervention Type OTHER

There is a retrospectiv observational study. No intervention will be performed

nonT2D-MCI

110 MCI subjects without diabetes. There is a retrospectiv observational study. No intervention will be performed.

There is a retrospectiv observational study. No intervention

Intervention Type OTHER

There is a retrospectiv observational study. No intervention will be performed

Interventions

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There is a retrospectiv observational study. No intervention

There is a retrospectiv observational study. No intervention will be performed

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* diagnosis of MCI using the NBACE neuropsychological tests battery.
* Age \>65 years.
* At least two years follow-up.
* 110 subjects with type 2 diabetes
* 110 subjects without diabetes
* written informed consent.

Exclusion Criteria

* patients with cerebrovascular disease (previous stroke, intracerebral lesions, etc.), including significant vascular load according to scale Fazekas (escor˃2)

Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No