Small Vessel Disease of Diabetes MellitusNCT03754608
Validating Imaging Biomarkers of Small Vessel Disease in Diabetic Individuals Using Advanced MRI Techniques.
An observational study of Small Vessel Disease of Diabetes Mellitus, run by Yale University at 1 site in United States.
Trial summary
To develop a set of biomarkers for imaging of small vessel disease in diabetic individuals using advanced MRI techniques. With this the investigators want to document progression of disease both radiologically and clinically. Read more about this study
- Who is it for?
- Ages 55 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Small Vessel Disease of Diabetes Mellitus
- What is being tested?
- MRI including cf-MRI, DTI, ASL and CVR.
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2018to 31 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Our study population are those with type 2 diabetes in mid-life and old age, who may or may not have cognitive deficits, whose cognitive deficits (when present) cannot be better explained by other factors. We exclude those who are unable to have MRI or cognitive testing due to a variety of reasons.
Who may be able to join
- A - Vascular cognitive impairment:
- Presence of diabetes
- The International Society of Vascular Behavioral and Cognitive Disorders (VASCOG) criteria for vascular cognitive impairment
- Age between 55 and 90 (inclusive)
- Score on the Montreal Cognitive Assessment (MOCA) 15 to 23
- Presence of a responsible caregiver who will accompany mild cognitive impaired (MCI) subjects to all procedures.
Show all 15Show fewer
- Evidence of vascular disease
- The patient should have a capacity to consent.
- English speakers
- B- Cognitively normal elderly Subjects:
- Presence of diabetes
- Absence of National Institute on Aging (NIA) - Alzheimer's Association core clinical criteria for probable Alzheimer's Disease (AD) and VASCOG criteria for vascular cognitive impairment.
- Objective memory scores within normal range for age (do not meet MCI Subjects criterion 2)
- Age between 55 and 90 (inclusive)
- English speakers
Who cannot join
- Any significant neurologic disease (other than vascular cognitive disease and stroke), such as Parkinson's disease, brain tumor, seizure disorder, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits.
- Any significant systemic disease including hepatic failure, heart failure, renal failure, Chronic obstructive pulmonary disease (COPD), active infection and autoimmune disease.
- Any significant systemic illness or unstable medical condition, including: uncontrolled or insulin-dependent diabetes mellitus, uncorrected hypothyroidism or hyperthyroidism, or systemic cancer.
- Investigational agents are prohibited 4 weeks prior to entry and for the duration of the study. Previous treatment with an investigational small molecule with anti-amyloid properties or passive immunization against amyloid within 1 year of study entry. Previous treatment with an active immunization against amyloid.
- History of schizophrenia or other major psychiatric disorder (DSM IV criteria).
- History of alcohol or substance abuse or dependence (DSM IV criteria) within the past 2 years.
Show all 12Show fewer
- Pregnancy, as determined by screening pregnancy tests for pre-menopausal females
- Impairment of visual or auditory acuity sufficient to interfere with study procedures.
- Education level < 6 years.
- Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body. The presence of claustrophobia, precluding MRI.
- Drink more than 5 alcoholic drinks per week or any heavy drinking days in the last 30 days
- Women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or partner is surgically sterile or she is postmenopausal (hormone contraceptives [oral, implant, injection, patch, or ring], contraceptive sponge, double barrier [diaphragm or condom plus spermicide], or intrauterine device (IUD)
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06510
About this study
To develop a set of biomarkers for imaging of small vessel disease in diabetic individuals using advanced MRI techniques. With this the investigators want to document progression of disease both radiologically and clinically.
Read the detailed description
The investigators will use a paradigm developed at Yale University called Cognitive Predictive Modelling (CPM) which takes connectivity data and reduces it to two smaller network which predict higher and lower performance in a particular task for which these networks have been optimized. Vascular measures will complement this measure.
- Being tested
- MRI including cf-MRI, DTI, ASL and CVR.
- Medical subject headings
- Diabetic Angiopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI including cf-MRI, DTI, ASL and CVR.Diagnostic test
Also called Neuropsychological testing (Cantab), basic laboratory blood tests, small number of CSF
A paradigm developed at Yale University called Cognitive Predictive Modelling which takes connectivity data and reduces it to two smaller network which predict higher and lower performance in a particular task for which these networks have been optimized. This will be supplemented by MRI vascular measures.
| Study group | Role | What they receive |
|---|---|---|
| Diabetics/No cognitive impairment | These are individuals with diabetes who do not have vascular cognitive impairment as determined by VASCOG criteria. Receives: Diagnostic Test: MRI including cf-MRI, DTI, ASL and CVR. | |
| Diabetics with vascular cognitive impairment | These are individuals with diabetes who have vascular cognitive impairment as determined by VASCOG criteria. Receives: Diagnostic Test: MRI including cf-MRI, DTI, ASL and CVR. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Odds ratio for the MRI vascular cognitive impairment biomarker.
This will be calculated from the sensitivity and specificity as compared to clinical diagnosis.
Measured: 2 years
Secondary outcomes (1)
Correlation between the biomarker and cognition
Assess whether the biomarker can predict the severity of the cognitive performance.
Measured: 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start7 Nov 2018
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Vessel Disease of Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arash Salardini, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754608
- Sponsor's protocol ID
- 2000023733
- Status last verified
- Apr 2021
- First submitted
- 16 Oct 2018
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating Imaging Biomarkers of Small Vessel Disease in Diabetic Individuals Using Advanced MRI Techniques.
- ClinicalTrials.gov ID
- NCT03754608
- Acronym / sponsor ID
- 2000023733
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To develop a set of biomarkers for imaging of small vessel disease in diabetic individuals using advanced MRI techniques. With this the investigators want to document progression of disease both radiologically and clinically.
Detailed description
The investigators will use a paradigm developed at Yale University called Cognitive Predictive Modelling (CPM) which takes connectivity data and reduces it to two smaller network which predict higher and lower performance in a particular task for which these networks have been optimized. Vascular measures will complement this measure.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetics/No cognitive impairment | – | Diagnostic Test: MRI including cf-MRI, DTI, ASL and CVR.These are individuals with diabetes who do not have vascular cognitive impairment as determined by VASCOG criteria. |
| Diabetics with vascular cognitive impairment | – | Diagnostic Test: MRI including cf-MRI, DTI, ASL and CVR.These are individuals with diabetes who have vascular cognitive impairment as determined by VASCOG criteria. |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Our study population are those with type 2 diabetes in mid-life and old age, who may or may not have cognitive deficits, whose cognitive deficits (when present) cannot be better explained by other factors. We exclude those who are unable to have MRI or cognitive testing due to a variety of reasons.
Key inclusion criteria (15 listed)
- Presence of diabetes
- The International Society of Vascular Behavioral and Cognitive Disorders (VASCOG) criteria for vascular cognitive impairment
- Age between 55 and 90 (inclusive)
- Score on the Montreal Cognitive Assessment (MOCA) 15 to 23
- Presence of a responsible caregiver who will accompany mild cognitive impaired (MCI) subjects to all procedures.
Key exclusion criteria (12 listed)
- Any significant neurologic disease (other than vascular cognitive disease and stroke), such as Parkinson's disease, brain tumor, seizure disorder, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits.
- Any significant systemic disease including hepatic failure, heart failure, renal failure, Chronic obstructive pulmonary disease (COPD), active infection and autoimmune disease.
- Any significant systemic illness or unstable medical condition, including: uncontrolled or insulin-dependent diabetes mellitus, uncorrected hypothyroidism or hyperthyroidism, or systemic cancer.
- Investigational agents are prohibited 4 weeks prior to entry and for the duration of the study. Previous treatment with an investigational small molecule with anti-amyloid properties or passive immunization against amyloid within 1 year of study entry. Previous treatment with an active immunization against amyloid.
- History of schizophrenia or other major psychiatric disorder (DSM IV criteria).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI including cf-MRI, DTI, ASL and CVR.Also: Neuropsychological testing (Cantab), basic laboratory blood tests, small number of CSFA paradigm developed at Yale University called Cognitive Predictive Modelling which takes connectivity data and reduces it to two smaller network which predict higher and lower performance in a particular task for which these networks have been optimized. This will be supplemented by MRI vascular measures. | Diagnostic test | Diabetics with vascular cognitive impairment, Diabetics/No cognitive impairment |
Primary outcome
Diagnostic Odds ratio for the MRI vascular cognitive impairment biomarker.
Time frame: 2 years
This will be calculated from the sensitivity and specificity as compared to clinical diagnosis.
1 secondary outcome
Correlation between the biomarker and cognition
Time frame: 18 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
Related trials for Small Vessel Disease of Diabetes Mellitus
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 3
KHENERFIN Study: A Trial to Evaluate the Efficacy and Safety of Sonlicromanol in Primary Mitochondrial Diseases
Mitochondrial Diseases, Maternally Inherited Diabetes and Deafness (MIDD)
RecruitingObservational study
Health for Hungary (H4H) - Longitudinal Collection of Blood Samples and Corresponding Data
Non-communicable Diseases (NCD), Neoplams
Recruiting
Neurologic Stem Cell Treatment Study
Neurologic Disorders, Nervous System Diseases
RecruitingObservational study
Imaging the Pathogenesis of Cerebral Small Vessel Disease
Ischemic Stroke, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arash Salardini, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Vessel Disease of Diabetes Mellitus, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Odds ratio for the MRI vascular cognitive impairment biomarker. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.