Natural History of Thyroid Function Disorders

NCT00001159 | Recruiting

• 2 other identifiers: 77000277-DK-0002
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

Participants in this study will be patients diagnosed with or suspected to have a thyroid function disorder. These conditions may include: hypothyroidism, hyperthyroidism, thyroid hormone resistance, Graves' Dermopathy, and thyroid-stimulating hormone (TSH) secreting pituitary adenomas. The main purpose of this study is to further understand the natural history, clinical presentation, and genetics of thyroid function disorders. Many of the tests performed are in the context of standard medical care that is offered to all patients with thyroid function disorders. In addition, blood and tissue samples may be taken for research and genetic studies....

Conditions

Hyperthyroidism; Hypothyroidism; Grave's Disease

Keywords

Hyperthyroidism; Hypothyroidism; Grave's Disease; Natural History; Thyroid-Stimulating Hormone Secreting Pituitary Ad

Outcome Measures

Primary Outcomes (1)

• evaluation of thyroid disorders

  Patients undergo routine history and physical examination, standard endocrine blood and urine tests, a standard TRH test, thyroid nuclear medicine scans, thyroidal radioiodine (RAI) or technetium (99mTc) uptake measurements, as well as X-ray, computed tomography (CT) or magnetic resonance imaging (MRI) studies or other standard diagnostic procedures, as clinically indicated.

  ongoing

Study Arms (1)

Thyroid disorders

Patients with thyroid disorders

Eligibility Criteria

• Age: 6 Months - 98 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

anyone meeting eligibility criteria.

You may qualify if:

• The categories of subjects eligible to participate in this study include:
• Patients with known or suspected thyroid abnormalities (e.g. hypothyroidism, hyperthyroidism, extreme iodine deficiency, and inherited forms of hypothyroidism resulting from abnormalities in the expression of genes coding for the TSH- beta subunit, Pax-8, TTF-2, Pit-I, Tg, PDS, and NIS.
• Patients with thyroid function test (TFT) abnormalities due to:
• Non-thyroidal illness
• Abnormalities of serum TH binding proteins leading to euthyroid hyperthyroxinemia or hypotriiodothyronemia.
• Genetic deficiency of thyroxine-binding globulin (TBG).
• Antibodies to mouse immunoglobulins leading to an artifactual elevation in the TSH ultrasensitive ("3rd generation") assay which may mimic "inappropriate" secretion of TSH.

You may not qualify if:

• Patients with known or suspected thyroid abnormalities will be eligible to p rticipate if the individual meets all of the following criteria:
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female, aged 6 months+.
• Hyperthyroid states include but are not restricted to:
• Graves' disease (GD) thought to result from thyroid-stimulating immunoglobulins (TSIg's), a subclass of which also stimulate eye muscle and fatty tissue producing exophthalmos (Graves' ophthalmopathy), as well as the skin in the pretibial area causing pretibial myxedema (Graves' dermopathy);
• Subacute thyroiditis (SAT), a painful inflammation thought to result from viral infection with Coxsackie, as well as other viruses;
• Silent thyroiditis, a painless inflammation thought to result from autoimmune attack of thyrocytes by antimicrosomal antibodies directed against thyroid peroxidase (TPO), as well as antithyroglobulin(anti-Tg) antibodies;
• Single or multiple hyperfunctioning thyroid nodules of unknown etiology, probably resulting from the activation of certain thyroid oncogenes and/or growth factors, such as the thyrotropin (TSH) receptor (TSHR) and the a-subunit of the G protein (Ga);
• Iodide-induced hyperthyroidism of unknown etiology;
• Surreptitious administration of thyroid hormone (TH), usually present in patients with underlying psychiatric disease or occasionally related to patients with obesity and other eating disorders
• Trophoblastic neoplasms, thought to result from high levels of hCG secretion, which, because of its structural similarity to TSH, causes "spillover" of action at the TSHR level;
• "Inappropriate" secretion of TSH, which may be present either in patients with TSH- producing pituitary tumors (TSHomas) or from a non-neoplastic cause, i.e. pituitary resistance to the action of thyroid hormone (3,4).
• Hypothyroid states include but are not restricted to:
• Primary (or thyroidal) hypothyroidism, usually resulting from auto-antibodies to thyroid proteins, such as antimicrosomal antibodies to TPO usually associated with lymphocytic (Hashimoto's) thyroiditis (HT) or atrophic thyroiditis, or blocking antibodies to the TSHR, usually in the context of non-goitrous hypothyroidism;
• Secondary (or pituitary) hypothyroidism, usually resulting from tumors of the pituitary of non-thyrotropic origin such, as growth hormone (GH)-secreting tumors or prolactinomas;

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Hyperthyroidism; Hypothyroidism

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Study Officials

• Sriram M Gubbi, M.D.

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Padmasree Veeraraghavan, R.N.

CONTACT

(301) 451-7710; padmasree.veeraraghavan@nih.gov

Sriram M Gubbi, M.D.

CONTACT

(301) 827-2770; sriram.gubbi@nih.gov

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: February 1, 1977
• Last Updated: April 29, 2026

Record last verified: 2026-01-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)