Multiple SclerosisNCT04748302
Impaired Glucose Tolerance and Cognition in MS
An observational study of Multiple Sclerosis, run by University of Virginia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 1 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Study population: Persons with RRMS or CIS between the ages of 18-59 who are not diabetic or on glucose regulating medications.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
About this study
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of glucose intolerance on clinical outcome measure of disability.
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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start6 Jan 2020
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Why it stopped: COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J. Nicholas Brenton, MD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748302
- Sponsor's protocol ID
- 21791
- Status last verified
- Feb 2021
- First submitted
- 6 Sep 2019
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impaired Glucose Tolerance and Cognition in MS
- ClinicalTrials.gov ID
- NCT04748302
- Acronym / sponsor ID
- 21791
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Persons with RRMS or CIS between the ages of 18-59 who are not diabetic or on glucose regulating medications.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
The study was stopped early (reason given: COVID). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of glucose intolerance on clinical outcome measure of disability. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.