Adrenal InsufficiencyNCT00005664
Evaluation of Patients With Endocrine-Related Conditions
An observational study of Adrenal Insufficiency and Pituitary Neoplasm, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Adrenal Insufficiency, Pituitary Neoplasm, Obesity
- How many people
- 1,588 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2000to 5 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read the detailed description
This protocol is designed to allow inpatient and outpatient evaluation of adults with a variety of endocrine disorders for purposes of research and physician education in our accredited endocrinology training programs. The research-directed evaluations may include blood, saliva, or urine samples, or evaluation tissue that was routinely collected for clinical care. In some patients with endocrine disorders, laboratory or radiological studies will be performed to confirm a diagnosis or to aid in the management of the patient, using standard approaches in current clinical practice. In some cases, the patient will receive medical, radiation or surgical treatment for their disorder. The purpose of these evaluations or treatments to support our clinical training or research missions.
- Conditions
- Adrenal Insufficiency, Pituitary Neoplasm, Obesity
- Keywords
- Healthy Volunteers, Endocrine Related Conditions, Endocrine Dysfunction, Early Pubertal Development
- Medical subject headings
- Adrenal Insufficiency, Pituitary Neoplasms, Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2000 (estimated)
- Study start22 May 2000
- Study completion5 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adrenal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,588 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lynnette K Nieman, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005664
- Sponsor's protocol ID
- 000127
- Other IDs
- 00-CH-0127
- Status last verified
- 5 Dec 2019
- First submitted
- 17 May 2000
- Last updated
- 16 Dec 2019
- Results posted
- No
Publications
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.
PubMed 24715566Sharma 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.
PubMed 22190002
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patients With Endocrine-Related Conditions
- ClinicalTrials.gov ID
- NCT00005664
- Acronym / sponsor ID
- 000127
- Conditions
- Adrenal Insufficiency, Pituitary Neoplasm, Obesity
- Keywords
- Healthy Volunteers, Endocrine Related Conditions, Endocrine Dysfunction, Early Pubertal Development
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 1,588 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 22 May 2000
- Study completion
- 5 Dec 2019
- First posted
- 18 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This protocol is designed to allow inpatient and outpatient evaluation of adults with a variety of endocrine disorders for purposes of research and physician education in our accredited endocrinology training programs. The research-directed evaluations may include blood, saliva, or urine samples, or evaluation tissue that was routinely collected for clinical care. In some patients with endocrine disorders, laboratory or radiological studies will be performed to confirm a diagnosis or to aid in the management of the patient, using standard approaches in current clinical practice. In some cases, the patient will receive medical, radiation or surgical treatment for their disorder. The purpose of these evaluations or treatments to support our clinical training or research missions.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Background: PubMed 24715566Raff 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.
- Background: PubMed 22190002Sharma 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynnette K Nieman, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenal Insufficiency and Pituitary Neoplasm, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005664, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019.