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| Name | Class |
|---|---|
| Baltimore VA Medical Center | FED |
| University of Maryland, Baltimore County | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Middle-aged and Older adults with Prediabetes | Middle-aged and Older adults with Prediabetes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitoring System (CGMS) | Device | Continuous Glucose Monitoring System (CGMS)- minimally invasive sensors that measure glucose concentrations at 5-min intervals over several days. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adults aged 50 years and older with prediabetes of any duration
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathleen Simpson | Contact | 4106057179 | Kathleen.Simpson@va.gov | |
| Ashley Splain, BA | Contact | asplain1@umbc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tasneem Khambaty, PhD | University of Maryland, Baltimore County | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore VA Geriatric Research Education and Clinical Center (GRECC) | Recruiting | Baltimore | Maryland | 21201 | United States |
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| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D060825 | Cognitive Dysfunction |
| D011236 | Prediabetic State |
| D003863 | Depression |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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Blood samples, inflammatory markers, fasting glucose
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 |
| D001523 | Mental Disorders |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |