Retinal Neurodegeneration in Type 2 Diabetes as Biomarker for Alzheimer´s Disease (DIALRET)
|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: NCT02360527|
Recruitment Status : Completed
First Posted : February 10, 2015
Last Update Posted : April 12, 2017
|Condition or disease|
|Retinal Neurodegeneration Alzheimer´s Disease Type 2 Diabetes|
A case control study in the recruitment will be carried out from the Diabetes outpatient clinic of a tertiary hospital (HUVH) and from the ACE Foundation. The investigators will include the following groups: 1) Type 2 diabetic patients with AD; B) Type 2 diabetic patients with MCI; 3) Type 2 diabetic patients with normal cognitive status; 4) Non-diabetic patients with AD. The groups will be matched by age (± 5 years), gender, risk factors related to AD (APOE genotype and family history of dementia), diabetes duration and Hba1c (±1%)- the last two criteria apply for the three groups of diabetic patients. Inclusion criteria: Written informed consent obtained from the patient; Age >65years; Diabetes duration>5 years; HbA1c < 10%; No apparent or mild non-proliferative DR according to the International Clinical Diabetic Retinopathy Disease Severity Scale. Exclusion criteria: Patients with other neurodegenerative diseases of the brain or retina (i.e. glaucoma) or cerebrovascular diseases. Sample size calculation: Assuming that diabetic patients will present around 30% of abnormal mfERG implicit time, and considering that this figure will be up 60% in those diabetic patients with AD, the number of patients required in each group would be 25. This calculation has been performed taking into account a 2-side risk level of 0.05 and a statistical power of 80%. However, it should be noted that this estimation has been performed taken into account the variables concerning AD. Therefore, it is foreseeable that more patients will be needed to obtain valid results for MCI. Consequently, the investigators feel it reasonable to extend the sample to 35 subjects per group.
The study will be divided into two stages (as will be further detailed): -Stage I: This will be the first step of the project and type 2 diabetic patients with AD and patients with normal cognitive status will be compared. -Stage II: Type 2 diabetic patients with MCI will be compared with patients with normal cognitive status or AD.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||126 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||Retinal Neurodegeneration in Type 2 Diabetes as Biomarker for Alzheimer´s Disease|
|Actual Study Start Date :||September 2014|
|Primary Completion Date :||November 2015|
|Study Completion Date :||December 2015|
Type 2 diabetic patients with AD
Type 2 diabetic patients with MCI
Type 2 diabetic patients controls
Non-diabetic patients with AD
- Retinal neurodegeneration among three groups of type 2 diabetic patients patients with AD, patients with MCI and patients without AD or MCI. [ Time Frame: 9 month ]
-To compare the prevalence of morphological (SD-OCT) and functional abnormalities (mfERG) related to retinal neurodegeneration among three groups of type 2 diabetic patients: patients with AD, patients with MCI and patients without AD or MCI. In addition, a group of non diabetic subjects with AD will also be included.
These groups will be matched by age, gender, duration of diabetes, HbA1C, and genetic risk factors for AD.
- To assess whether the retinal neurodegenerative features are related to the severity of AD.
- To explore whether the combined retinal neurodegeneration in diabetic patients with AD has a different functional and/or morphological pattern in comparison with neurodegeneration secondary to diabetes alone.
Biospecimen Retention: Samples With DNA
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): NCT02360527
|Vall d´Hebron Research Institute VHIR|
|Barcelona, Catalunya, Spain, 08035|
|Principal Investigator:||Cristina Hernandez, MD, PhD||Vall d´Hebron Research Institute VHIR|