Glucose Variability and Cognition in Prediabetes

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorUniversity of Maryland, Baltimore

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 50 years and older

At least 8th grade education

Disqualifiers

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)

Trial population

Adults aged 50 years and older with prediabetes of any duration

Trial design

Design model

Ecologic or community

Time perspective

Cross-sectional

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Middle-aged and Older adults with Prediabetes1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
Day 10
2

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

Time frame
Day 10
3

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)

Time frame
Day 10

Secondary outcomes

1

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

Time frame
Day 10
2

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

Time frame
Day 10
3

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

Time frame
Day 10

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Maryland, Baltimore

Lead sponsor

Baltimore VA Medical Center

Collaborator

University of Maryland, Baltimore County

Collaborator