Glucose Variability and Cognition in Prediabetes

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04201600
• Other study ID #: HP-00087044
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: University of Maryland, Baltimore
• Contact: Kathleen Simpson
• Phone: 4106057179
• Email: Kathleen.Simpson[@]va.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Cognitive Decline
• Cognitive Dysfunction
• Depression
• Functional Status
• Glucose Intolerance
• Glucose Metabolism Disorders
• Glucose Metabolism Disorders (Including Diabetes Mellitus)
• Metabolic Diseases
• PreDiabetes
• Prediabetic State

Intervention

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.

Locations

Country	Name	City	State
United States	Baltimore VA Geriatric Research Education and Clinical Center (GRECC)	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Baltimore VA Medical Center, University of Maryland, Baltimore County

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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