Type 2 Diabetes Mellitus as Catalyst for Alzheimer's Disease (DIACEA)

Type 2 Diabetes Mellitus as Accelerator for the Progression to Alzheimer's Disease in Patients With Mild Cognitive Impairment

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus Type 2; Alzheimer´s Disease
• Intervention / Treatment: Other: There is a retrospectiv observational study. No intervention

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 Type: Observational
• Enrollment (Actual): 202

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Vall d´Hebron University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
T2D-MCI; 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; 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.	Other: There is a retrospectiv observational study. No intervention; There is a retrospectiv observational study. No intervention will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The rate of conversion to Alzheimer's disease (AD)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 months

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Investigators: Study Director: Rafael Simo Canonge, PhD, MD, VHIR Research Institute

Publications and helpful links

General Publications

• Espinosa A, Alegret M, Valero S, Vinyes-Junque G, Hernandez I, Mauleon A, Rosende-Roca M, Ruiz A, Lopez O, Tarraga L, Boada M. A longitudinal follow-up of 550 mild cognitive impairment patients: evidence for large conversion to dementia rates and detection of major risk factors involved. J Alzheimers Dis. 2013;34(3):769-80. doi: 10.3233/JAD-122002. Erratum In: J Alzheimers Dis. 2015;43(1):335.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: July 16, 2015
• First Submitted That Met QC Criteria: July 16, 2015
• First Posted (Estimate): July 17, 2015

Study Record Updates

• Last Update Posted (Actual): April 12, 2017
• Last Update Submitted That Met QC Criteria: April 11, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: patients; The risk of progession
• Additional Relevant MeSH Terms: Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Endocrine System Diseases; Neurodegenerative Diseases; Dementia; Tauopathies; Diabetes Mellitus; Diabetes Mellitus, Type 2; Alzheimer Disease
• Other Study ID Numbers: PR(AG)32/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO