- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02360527
Retinal Neurodegeneration in Type 2 Diabetes as Biomarker for Alzheimer´s Disease (DIALRET)
Study Overview
Status
Detailed Description
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Catalunya
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Barcelona, Catalunya, Spain, 08035
- Vall d´Hebron Research Institute VHIR
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Type 2 diabetic patients with AD
35 patients
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Type 2 diabetic patients with MCI
35 patients
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Type 2 diabetic patients controls
35 patients
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Non-diabetic patients with AD
35 patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
9 month
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Collaborators and Investigators
Investigators
- Principal Investigator: Cristina Hernandez, MD, PhD, Vall d´Hebron Research Institute VHIR
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- 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
- Nerve Degeneration
Other Study ID Numbers
- PR(IR)15/2014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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