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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02501876
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Alzheimer´s Disease Diabetes Mellitus Type 2 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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 202 participants
Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration: 2 Years
Official Title: Type 2 Diabetes Mellitus as Accelerator for the Progression to Alzheimer's Disease in Patients With Mild Cognitive Impairment
Actual Study Start Date : May 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : May 2016


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




Primary Outcome Measures :
  1. The rate of conversion to Alzheimer's disease (AD) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. The presence of common alleles for Alzheimer's disease (AD) and Diabetes mellitus type 2 [ Time Frame: 4 months ]
    The genetic role in the risk of conversion to AD and Diabetes mellitus type 2


Biospecimen Retention:   Samples With DNA
Whole blood will be preserved in order to perform a genetic study of 10 genes related both with type 2 diabetes and Alzheimer´s disease.


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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501876


Locations
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Spain
Vall d´Hebron University Hospital
Barcelona, Spain, 08035
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
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Study Director: Rafael Simo Canonge, PhD, MD VHIR Research Institute
Additional Information:

Publications:
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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT02501876    
Other Study ID Numbers: PR(AG)32/2015
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
The risk of progession
patients
Additional relevant MeSH terms:
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Alzheimer Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders