Impaired Glucose Tolerance and Cognition in MS

NCT04748302 | Terminated

• 1 other identifier: 21791
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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)

  1 year

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: February 10, 2021
• Study Start: January 6, 2020
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

US (1)