Type 2 Diabetes Mellitus as Catalyst for Alzheimer's Disease

Completed

• Conditions: Alzheimer´s Disease; Diabetes Mellitus Type 2
• Interventions: Other: There is a retrospectiv observational study. No intervention

• Registration Number: NCT02501876
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-07-16
• Study First Submitted QC: 2015-07-16
• Study First Posted: 2015-07-17
• Primary Completion: 2015-09
• Study Completion: 2016-05
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-11
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
T2D-MCI	There is a retrospectiv observational study. No intervention	110 MCI subjects with type 2 diabetes. There is a retrospectiv observational study. No intervention will be performed.
nonT2D-MCI	There is a retrospectiv observational study. No intervention	110 MCI subjects without diabetes. There is a retrospectiv observational study. No intervention will be performed.

Primary Outcome Measures

Name	Time	Method
The rate of conversion to Alzheimer's disease (AD)	6 months

Secondary Outcome Measures

Name	Time	Method
The presence of common alleles for Alzheimer's disease (AD) and Diabetes mellitus type 2	4 months	The genetic role in the risk of conversion to AD and Diabetes mellitus type 2

Trial Locations

Locations (1)

Vall d´Hebron University Hospital; 🇪🇸 Barcelona, Spain