Glucose Variability and Cognition in Prediabetes

Sponsor
University of Maryland, Baltimore (Other)
Overall Status
Recruiting
CT.gov ID
NCT04201600
Collaborator
Baltimore Veterans Affairs Medical Center (Other), University of Maryland, Baltimore County (Other)
30
1
34
0.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Continuous Glucose Monitoring System (CGMS)

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 Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Ecologic or Community
Time Perspective:
Cross-Sectional
Official Title:
Relations of Glucose Variability With Cognitive Function and Functional Status Among Older Adults at Risk for Diabetes
Actual Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Nov 30, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Middle-aged and Older adults with Prediabetes

Middle-aged and Older adults with Prediabetes

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.

Outcome Measures

Primary Outcome Measures

  1. 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)

  2. 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

  3. 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

  1. 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

  2. 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

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Baltimore VA Geriatric Research Education and Clinical Center (GRECC) Baltimore Maryland United States 21201

Sponsors and Collaborators

  • University of Maryland, Baltimore
  • Baltimore Veterans Affairs Medical Center
  • University of Maryland, Baltimore County

Investigators

  • Principal Investigator: Tasneem Khambaty, PhD, University of Maryland, Baltimore County

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Leslie Katzel, Associate Professor, University of Maryland, Baltimore
ClinicalTrials.gov Identifier:
NCT04201600
Other Study ID Numbers:
  • HP-00087044
First Posted:
Dec 17, 2019
Last Update Posted:
Mar 29, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Leslie Katzel, Associate Professor, University of Maryland, Baltimore
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 29, 2022