Glucose Variability and Cognition in Prediabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Relations of Glucose Variability With Cognitive Function and Functional Status Among Older Adults at Risk for Diabetes

Conditions
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Glucose Metabolism Disorders (Including Diabetes Mellitus), Cognitive Decline, Functional Status, PreDiabetes, Aging, Depression

Intervention / Treatment
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* Device: Continuous Glucose Monitoring System (CGMS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Middle-aged and Older adults with Prediabetes<br>Middle-aged and Older adults with Prediabetes | Device: Continuous Glucose Monitoring System (CGMS)<br>* Continuous Glucose Monitoring System (CGMS)- minimally invasive sensors that measure glucose concentrations at 5-min intervals over several days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aggregate Executive Functioning Score | Scores on the following standard neurocognitive tests will be z-transformed based on their respective means and standard deviations and combined into one aggregate total score such that higher values mean better executive functioning: Trails Making A and B, The Stroop-Color Word Test, Digit Span subscale of the Wechsler Adult Intelligence Scale - Revised (WAIS-IV), Digit Symbol Substitution Test (DSST) | Day 10 | 
| Aggregate Memory Score | Scores on the following standard neurocognitive tests will be z-transformed based on their respective means and standard deviations and combined into one aggregate total score such that higher values mean better memory ability: California Verbal Learning Test, Benton Visual Retention Test | Day 10 | 
| Aggregate Language Score | Scores on the following standard neurocognitive tests will be z-transformed based on their respective means and standard deviations and combined into one aggregate total score such that higher values mean better language abilities: Boston Naming Test, Controlled Oral Word Association Test (COWA) | Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aggregate Physical Functioning Score | Scores on the following standard neurocognitive tests will be summed into one aggregate total score such that higher values mean better physical functioning: gait speed, short physical performance battery (SPPB), handgrip strength, and four-square step test | Day 10 | 
| Activities of Daily Living (ADL) total score | Responses on this standard measure will be scored according to guidelines to create a total score for functional status | Day 10 | 
| Instrumental Activities of Daily Living (IADL) total score | Responses on this standard measure will be scored according to guidelines to create a total score for functional status | Day 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glucose Variability, Continuous Glucose Monitoring System (CGMS), Prediabetes, Aging, Physical Functioning, Neurocognition, Cognitive Decline