An observational study in Alzheimer´s Disease and Diabetes Mellitus Type 2, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Completed at 1 site in Spain. Open to participants aged 65 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-04-12.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Observational
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.
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.
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A retrospective case-control study will be conducted in the Department of Endocrinology and Nutrition Hospital Vall d'Hebron, in collaboration with the department of Neurology and Laboratory. We will review the medical records and the complete neuropsychological evaluation of 110 subjects with MCI and DM-2 matched by age, sex, and cardiovascular risk factors with 110 non-diabetic subjects with MCI. We will select the patients (diabetic or non-diabetic) with a minimum follow-up of 2 years, and whose neuropsychological assessment has been performed using the battery NBACE to ensure a uniform evaluation criteria. In addition, only patients who have determined the ApoE genotype and those who have previously undergone brain MRI will be included.
Exclusion Criteria:
110 MCI subjects with type 2 diabetes. There is a retrospectiv observational study. No intervention will be performed.
Other: There is a retrospectiv observational study. No intervention
110 MCI subjects without diabetes. There is a retrospectiv observational study. No intervention will be performed.
Other: There is a retrospectiv observational study. No intervention
There is a retrospectiv observational study. No intervention will be performed
The rate of conversion to Alzheimer's disease (AD)
Time frame: 6 months
The presence of common alleles for Alzheimer's disease (AD) and Diabetes mellitus type 2
The genetic role in the risk of conversion to AD and Diabetes mellitus type 2
Time frame: 4 months
Plan to share: No
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Hospital Universitari Vall d'Hebron Research Institute