Recruiting

Natural History of Thyroid Function Disorders

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

Collected from past medical records and data - Retrospective
Who is being recruted

Hyperthyroidism

+ Hypothyroidism
+ Grave's Disease
From 6 Months to 98 Years
+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: February 1977

See protocol details

Summary

Principal SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ContactPadmasree Veeraraghavan, R.N.
Last updated: October 7, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 1977Actual date on which the first participant was enrolled.

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.... Patients with thyroid function abnormalities (hyperthyroidism, hypothyroidism) are studied and treated in this protocol. 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. The goals of this study are: * 1\. To understand the pathophysiology and various causes of thyroid function abnormalities (e.g., hyperthyroidism, hypothyroidism). * 2\. To longitudinally follow the effects of standard therapies for patients with abnormal thyroid functions. * 3\. To create a repository of clinical data and biospecimens for future research of thyroid disorders. Our objective will be accomplished by obtaining clinical data and biospecimens during standard care procedures and tests performed on enrolled subjects being evaluated as an outpatient in the clinic or as an inpatient at the NIH Clinical Center.

Official TitleNatural History of Thyroid Function Disorders 
Principal SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ContactPadmasree Veeraraghavan, R.N.
Last updated: October 7, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
2500 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Case-only
These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

How participants are selected
Participants are selected without using randomization. They may be chosen based on convenience, access, or willingness to participate. This approach is common when random selection isn’t practical.
Another way to select participants is through a probability sample, where participants are chosen randomly, so everyone has an equal chance to be included.

How information is collected
Researchers use data that has already been collected in the past, often through medical records or historical databases. This helps identify potential patterns or risk factors after outcomes have already occurred.Other Ways to Collect Data
Prospective: These studies collect new data moving forward over time.
Cross-sectional: These studies collect data at one single point in time.
Others: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 6 Months to 98 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Hyperthyroidism
Hypothyroidism
Grave's Disease
Criteria
7 inclusion criteria required to participate
Hypothyroid states include but are not restricted to: 1. 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; 2. Secondary (or pituitary) hypothyroidism, usually resulting from tumors of the pituitary of non-thyrotropic origin such, as growth hormone (GH)-secreting tumors or prolactinomas; 3. Tertiary (or hypothalamic) hypothyroidism, usually resulting from a deficiency in the hypothalamic hormone thyrotropin-releasing hormone (TRH), either of unknown etiology or secondary to a pituitary tumor; 4. Bio-inactive TSH, either relating to an endogenous abnormality of hypothalamic hormones or secondary to pituitary tumors (and usually related to abnormal glycosylation patterns of the TSH molecule); 5. Generalized resistance to thyroid hormone (RTH), a disease which has been shown to be due to abnormalities in the TH receptor, c-erbA-beta (or TR- beta).
The above are the principal disorders under study, but we may also investigate other abnormalities, such as 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 (among others).
Patients with known or suspected thyroid abnormalities will be eligible to p rticipate if the individual meets all of the following criteria:
1. Stated willingness to comply with all study procedures and availability for the duration of the study.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Patients with thyroid disorders
Study Objectives
Primary Objectives

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
National Institutes of Health Clinical CenterBethesda, United StatesSee the location
Recruiting
One Study Center