Impaired Glucose Tolerance and Cognition in MS

February 6, 2021 updated by: J. Nicholas Brenton, MD, University of Virginia
This is a pilot study to compare cognitive performance in two groups of subjects with multiple sclerosis; those with normal glucose tolerance and those with impaired glucose tolerance. The study consists of a 2 hour oral glucose tolerance test, patient reported outcomes, a series of cognitive functioning tests, and outpatient physical assessment using a pedometer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Investigators plan to recruit 100 compliant patients with relapsing-remitting MS who are willing to come fasting for an oral glucose tolerance test to determine the relationship between glucose tolerance and cognition in MS patients.

Eligible study subjects expressing interest will be given a copy of the consent to review and will have the opportunity to ask questions. If the subject passes screening, they will be invited for their research visit. Signed consent form at the visit will be obtained before any study related procedures take place.

Baseline Measurements: Measurements for all subjects will include age, race/ethnicity, sex, weight, height, waist circumference, blood pressure. Relevant medical history, current medications, and family history diabetes will be reviewed and documented by both subject report and medical records. If the subject is a woman of child-bearing ability, urine pregnancy test will be done in order to exclude pregnant subjects. All subjects will then have an IV placed and have blood drawn to measure their fasting blood glucose level. Fasting blood glucose above 126 ug/dl would be a screen failure for this study.

Labs: The following labs will be drawn for all subjects.

  • Blood glucose management (hemoglobin A1C, insulin-like growth factor, insulin) - these tests show how your body manages sugar
  • Lipids & Metabolic Markers (fasting lipid profile, leptin, adiponectin) - these measure signal proteins in your blood for metabolism
  • Cytokine profile - to assess impact of blood sugar and inflammatory factors (molecules that may indicate how well your immune system works) on recovery from your MS relapse
  • Sodium level - to assess how your body uses water
  • Vitamin D25 - measures amount of vitamin D in your body
  • Neuro-filament light measurement - marker of neurodegeneration

Oral Glucose Tolerance Test: After baseline measurements and labs are obtained, subjects will drink a 75g glucose drink. Labs (blood glucose and insulin levels) will be drawn every 30 minutes for a total of 2 hours.

In between blood draws, the subjects will undergo functional testing and complete questionnaires. A neurological exam will also be done that includes 8 functional systems: pyramidal, cerebellar, sensory, brainstem, vision, bowel and bladder, mental, and ambulation.

Cognitive testing will include the single Digit Modalities Test (SDMT) which is a timed test measuring thinking speed associating numbers and symbols as well as the cogstate which is a computer based assessment that tests cognitive levels.In addition, all subjects will undergo the sloan Low Contrast Vision testing (LCVA) which assesses your ability to see letters at different contrast levels.

Subjects will complete questionnaires that will ask about their fatigue level, daily activities, sleep habits, and how they are feeling physically, emotionally, and mentally.

At the end of the visit subjects will be discharged to home with an ActiGraph GT3X+ accelerometer, a waist-worn device, to measure community-based ambulation (a measure of physical activity). Subjects will complete 7 days of wear-time and will return accelerometers by mail.

This study only requires one visit to the University of Virginia and will take approximately 3 hours.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 59 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Persons with RRMS or CIS between the ages of 18-59 who are not diabetic or on glucose regulating medications.

Description

Inclusion Criteria:

  • Ability to provide informed consent
  • Diagnosis of Clinically Isolated Syndrome (CIS) or Relapsing Remitting Multiple Sclerosis (RRMS) confirmed by McDonald 2010 criteria
  • EDSS < 6.5 at time of visit

Exclusion Criteria:

  • Diabetes type I or II
  • use of glucose regulating medications
  • fasting blood glucose of > 126 mg/dl
  • known cardiac or respiratory disease
  • morbid obesity (BMI >40)
  • steroid exposure within 4 weeks of enrollment
  • pregnancy or current use of hormone replacement therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessment of glucose intolerance on clinical outcome measure of disability.
Time Frame: 1 year
The expanded disability scale (EDSS) will be used to determine a subjects level of disability. This value will then be compared to the subjects category of glucose intolerance, measured by yes (abnormal glucose tolerance) or no (normal glucose tolerance). This is on a score from 0 (no disability) to 8 (bedridden)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 6, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21791

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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