Improving White Matter Integrity With Thyroid Hormone

NCT04098991 | Completed FDA Drug

• 2 other identifiers: 2016-06785R21NS095723
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Animal studies have shown that thyroid hormone can improve white matter integrity after damage to myelin, which insulates and protects nerves. It is currently unknown whether this type of repair can occur in humans. The purpose of the proposed study is to examine the impact of thyroid hormone on white matter integrity in humans using two complementary, state-of-the-art neuroimaging techniques: high angular diffusion imaging and multicomponent relaxometry.

Conditions

Hypothyroidism

Keywords

neuroimaging; thyroid; white matter

Outcome Measures

Primary Outcomes (2)

• High Angular Diffusion Tensor Imaging

  Change in baseline white matter track integrity at 3 months and 6 months

  6 months

• Multi-Component Relaxometry

  Change in baseline white matter track integrity at 3 months and 6 months

  6 months

Secondary Outcomes (4)

• Patient Health Questionaire

  Collected at Baseline, 3 month follow-up, 6 month follow-up

• NIH Toolbox : Dimensional Change Card Sort Test

  Collected at Baseline, 3 month follow-up, 6 month follow-up

• NIH Toolbox : Pattern Comparison Processing Speed Test

  Collected at Baseline, 3 month follow-up, 6 month follow-up

• NIH Toolbox : Flanker Inhibitory Control and Attention Test

  Collected at Baseline, 3 month follow-up, 6 month follow-up

Study Arms (1)

Participants with primary hypothyroidism

All participants will receive the same treatment (levothyroxine, a synthetic T4 hormone replacement) at a dose that will be titrated using serum thyrotropin (TSH) levels as a goal, according to the American Thyroid Association Task Force recommendations

Drug: Levothyroxine

Interventions

Levothyroxine DRUG

All participants will be treated for their hypothyroidism according to the standard of care as reflected in recent guidelines from the American Thyroid Association.

Participants with primary hypothyroidism

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

We are seeking a population of subjects clinically indicated to receive thyroid hormone for hypothyroidism.

You may qualify if:

• Age: 21-60 years of age
• A diagnosis of primary hypothyroidism from autoimmune thyroiditis (Hashimoto)
• Able to give informed consent.

You may not qualify if:

• Major depressive disorder with or without active suicidal ideation
• Mild or major neurocognitive disorder;
• Presence of contraindications to magnetic resonance imaging (presence of ferrous-containing metals within the body (e.g., aneurysm clips, shrapnel/retained particles)
• Inability to tolerate small, enclosed spaces without anxiety (e.g., claustrophobia)
• Unwilling/unable to sign informed consent document
• Positive urine drug screen results;
• Pregnancy (positive pregnancy test), trying to become pregnant, or lactation

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Hypothyroidism; Thyroid Diseases

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Olusola A Ajilore, MD/PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Associate Director, Residency Training and Education Co-Director, Adult/Neuroscience Research Track

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: September 23, 2019
• Study Start: November 8, 2017
• Primary Completion: November 8, 2019
• Study Completion: November 8, 2019
• Last Updated: April 10, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)