Glucose Variability and Cognition in Prediabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continuous Glucose Monitoring System (CGMS).
- Who it may be relevant to
- Registry conditions: Glucose Metabolism Disorders (Including Diabetes Mellitus), Cognitive Decline, Functional Status, PreDiabetes. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Relations of Glucose Variability with Cognitive Function and Functional Status Among Older Adults At Risk for Diabetes
Overview
This study examines the association of variability in glucose values over a 10-day period with cognitive function and functional status among individuals with prediabetes, aged 50 or older.
Detailed description
Type 2 diabetes (T2DM) is now widely considered a major public health epidemic. T2DM is highly prevalent worldwide, is among the leading causes of death, and is an independent risk factor for dementia and less severe forms of cognitive dysfunction. The investigators are utilizing novel technology to understand the role of variability in glucose on neurocognition and functional status among middle-aged and older adults at risk for diabetes. The central hypothesis is that even before diabetes onset, variability in glucose will be associated with worse cognitive function and lower functional status. Participants will be asked to wear a glucose monitoring device over a 10-day period in their home environment. Assessment of functional status and neurocognitive function, in addition to sociodemographic factors, health habits and mood will also occur over two study visits.
Interventions
- Device Continuous Glucose Monitoring System (CGMS)
Continuous Glucose Monitoring System (CGMS)- minimally invasive sensors that measure glucose concentrations at 5-min intervals over several days.
Primary outcome measures
- Aggregate Executive Functioning Score [Time frame: Day 10]
- Aggregate Memory Score [Time frame: Day 10]
- Aggregate Language Score [Time frame: Day 10]
Secondary outcome measures (3)
- Aggregate Physical Functioning Score [Time frame: Day 10]
- Activities of Daily Living (ADL) total score [Time frame: Day 10]
- Instrumental Activities of Daily Living (IADL) total score [Time frame: Day 10]
Eligibility criteria
Inclusion criteria
- Aged 50 years and older
- At least 8th grade education
Exclusion criteria
- Diagnosed type 1 or type 2 diabetes
- Current use of mediation for diabetes (oral hypoglycemic agents, insulin), or with diabetic properties (e.g., steroids)
- Chronic disorders (cardiovascular disease, peripheral vascular disease, stroke, transient ischemic attack, chronic kidney disease, past year cancer)
- Neurological disorders (e.g., Parkinson's, epilepsy, multiple sclerosis)
- History of dementia or suspected dementia
- Known HIV
- Serious mental illness, psychosis, or use of psychotropic medication
- Heavy alcohol use
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Ecologic or community
Study locations
United States · 1 center
- Baltimore VA Geriatric Research Education and Clinical Center (GRECC) — Baltimore
Identifiers
NCT: NCT04201600 · HP-00087044