Glucose Variability and Cognition in Prediabetes

Recruiting

• Conditions: Cognitive Decline; Aging; Functional Status; PreDiabetes; Depression; Glucose Metabolism Disorders (Including Diabetes Mellitus)
• Interventions: Device: Continuous Glucose Monitoring System (CGMS)

• Registration Number: NCT04201600
• Lead Sponsor: University of Maryland, Baltimore

Brief Summary

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.

Study Timeline

• Study First Submitted: 2019-12-05
• Study First Submitted QC: 2019-12-14
• Study First Posted: 2019-12-17
• Study Start: 2022-03-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2026-11-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Middle-aged and Older adults with Prediabetes	Continuous Glucose Monitoring System (CGMS)	Middle-aged and Older adults with Prediabetes

Primary Outcome Measures

Name	Time	Method
Aggregate Executive Functioning Score	Day 10	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)
Aggregate Memory Score	Day 10	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
Aggregate Language Score	Day 10	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)

Secondary Outcome Measures

Name	Time	Method
Aggregate Physical Functioning Score	Day 10	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
Activities of Daily Living (ADL) total score	Day 10	Responses on this standard measure will be scored according to guidelines to create a total score for functional status
Instrumental Activities of Daily Living (IADL) total score	Day 10	Responses on this standard measure will be scored according to guidelines to create a total score for functional status

Trial Locations

Locations (1)

Baltimore VA Geriatric Research Education and Clinical Center (GRECC); 🇺🇸 Baltimore, Maryland, United States