NCT00005664

Brief Summary

This study will evaluate patients with a variety of endocrine disorders in order to 1) learn more about conditions that affect the endocrine glands (glands that secrete hormones) and 2) to train physicians in endocrinology. Patients of all ages with endocrine-related conditions may be eligible for evaluation under this protocol. Those enrolled may be required to provide blood, saliva, urine or stool samples, and to undergo ultrasound examination of the thyroid gland, ovaries or testes, adrenal glands or other parts of the body. Laboratory or X-ray studies may be done for diagnostic or treatment purposes. In some cases, patients will receive medical or surgical treatment for their disorder. Patients and family members of patients with a hereditary disorder may be asked to provide a blood sample for genetic analysis.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,588

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2000

Completed
4 days until next milestone

Study Start

First participant enrolled

May 22, 2000

Completed
19.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2019

Completed
Last Updated

December 16, 2019

Status Verified

December 5, 2019

First QC Date

May 17, 2000

Last Update Submit

December 13, 2019

Conditions

Keywords

Healthy VolunteersEndocrine Related ConditionsEndocrine DysfunctionEarly Pubertal Development

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients of all ages with endocrine-related conditions will be eligible for this protocol.
  • Both male and female subjects of all ethnic backgrounds are eligible.

You may not qualify if:

  • Unstable patients and patients with severe organ failure that may affect/limit the endocrine work-up and exhaust Clinical Center and/or NICHD resources will be excluded if appropriate. Decisions will be made on a case by case basis by investigators.
  • Subjects who are unable to provide informed consent will not be accrued; however, if patients have previously given consent, they will continue to be seen for ongoing clinical care. If they require medically-indicated procedures, we will follow NIH policy regarding obtaining consent from next of kin if they have not indicated a medical decision maker.
  • Minor subjects will not be accrued; they will be referred to NICHD protocols or other NIDDK protocols for evaluation of eligibility.
  • Prisoners will not be recruited. If a subject becomes incarcerated during the study, s/he may continue to participate so as to not compromise medical care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

  • Raff H, Sharma ST, Nieman LK. Physiological basis for the etiology, diagnosis, and treatment of adrenal disorders: Cushing's syndrome, adrenal insufficiency, and congenital adrenal hyperplasia. Compr Physiol. 2014 Apr;4(2):739-69. doi: 10.1002/cphy.c130035.

    PMID: 24715566BACKGROUND
  • Sharma ST, Nieman LK. Prolonged remission after long-term treatment with steroidogenesis inhibitors in Cushing's syndrome caused by ectopic ACTH secretion. Eur J Endocrinol. 2012 Mar;166(3):531-6. doi: 10.1530/EJE-11-0949. Epub 2011 Dec 21.

    PMID: 22190002BACKGROUND

MeSH Terms

Conditions

Adrenal InsufficiencyPituitary NeoplasmsObesity

Condition Hierarchy (Ancestors)

Adrenal Gland DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHypothalamic NeoplasmsSupratentorial NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypothalamic DiseasesPituitary DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lynnette K Nieman, M.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2000

First Posted

May 18, 2000

Study Start

May 22, 2000

Study Completion

December 5, 2019

Last Updated

December 16, 2019

Record last verified: 2019-12-05

Locations