Endocrine DiseasesNCT00006073
Endocrine Studies in Health and Disease
An observational study of Endocrine Diseases, 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 healthy normal volunteers and patients with a variety of endocrine disorders to 1) learn more about conditions that affect the endocrine glands (glands that secrete hormones) and 2) train physicians in endocrinology. Read more about this study
- Who is it for?
- Ages Up to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Endocrine Diseases
- How many people
- 3,090 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2000to 31 Aug 2016
- 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 Up to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy subjects and patients with endocrine-related conditions of all ages are eligible for this protocol. The actual selection of patients most appropriate for clinical training needs will be made by protocol investigators.
- Subjects with disabilities are not formally excluded from the study unless the disability would specifically prevent their participation. If a subject with cognitive impairment wishes to participate, there must be available a family member or other qualified individual holding a durable power of attorney who is able to guide the impaired subject s participation and be an advocate for their interests. This participation is limited to the non-research, clinical training arm of the study.
Who cannot join
None listed.
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 healthy normal volunteers and patients with a variety of endocrine disorders to 1) learn more about conditions that affect the endocrine glands (glands that secrete hormones) and 2) train physicians in endocrinology.
Patients with endocrine-related conditions and healthy volunteers of all ages may be eligible for this study.
Read more
All participants will have a physical examination medical and history. They may be required to provide blood, saliva or urine samples and undergo ultrasound (using sound waves) or magnetic resonance (using a magnetic field) imaging to visualize internal body structures.
Some healthy adult volunteers will have hormone-stimulating tests to assess endocrine function. These tests measure blood hormone levels before and after injection of a synthetic form of a hormone. A device called a heparin lock, through which the hormone is injected and the blood samples are collected, is placed in a vein in the arm or hand. Blood samples are drawn before the hormone is injected and at various intervals after the injection to measure levels of the hormone. These tests, which last from 1 to 3 hours, may include the following:
- CRH stimulation test corticotropin-releasing hormone is given to test pituitary and adrenal gland function
- ACTH stimulation test adrenocorticotrophic hormone is given to test adrenal gland function
- LHRH stimulation test luteinizing hormone-releasing hormone is given to test pituitary gland function
- TRH stimulation test thyroid-releasing hormone is given to test pituitary and thyroid gland function
- GHRH stimulation test growth hormone releasing hormone is given to measure growth hormone levels.
An oral glucose tolerance test, which is similar to the stimulation tests, may also be done to measure blood glucose (sugar) and insulin levels after drinking a sugary liquid.
Healthy volunteers and patients with a hereditary endocrine disorder and their family members may also be asked to provide a blood sample for genetic studies of inherited endocrine disorders. Patients with endocrine-related disorders may be offered medical or surgical treatment for their disorder.
AcAccess http://turners.nichd.nih.gov/ for additional study publications.
Read the detailed description
This protocol is designed to allow endocrine-related evaluations of healthy subjects and patients with a variety of endocrine disorders. Healthy subjects may be studied to obtain normative data for endocrine tests involving blood, urine, saliva, ultrasound and magnetic resonance examinations. If not eligible for a specific NICHD research protocol, patients with endocrine-related conditions may be evaluated under the auspices of this protocol to advance the clinical skills of physicians participating in NICHD clinical research and training programs, and to provide stimuli for new clinical research initiatives. Standard, medically-indicated laboratory or radiological studies may be performed to confirm a diagnosis or to aid in the management of the patient. In some cases, the patient will receive medical or surgical treatment for their disorder, according to current clinical practice. The overall purpose of endocrine evaluations under this protocol is to support our clinical training and research missions.
- Conditions
- Endocrine Diseases
- Keywords
- Evaluation, Endocrinology, Hormones, Metabolism, Teaching, Endocrine Disorder
- Medical subject headings
- Endocrine System Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2003 (estimated)
- Study start19 Jul 2000
- Study completion31 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endocrine DiseasesStudies 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
- Time perspective
- Other
- Enrolment
- 3,090 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
- Margaret F Keil, C.R.N.P., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006073
- Sponsor's protocol ID
- 000180
- Other IDs
- 00-CH-0180
- Status last verified
- 31 Aug 2016
- First submitted
- 25 Jul 2000
- Last updated
- 6 Oct 2017
- Results posted
- No
Publications
Han JC, Reyes-Capo DP, Liu CY, Reynolds JC, Turkbey E, Turkbey IB, Bryant J, Marshall JD, Naggert JK, Gahl WA, Yanovski JA, Gunay-Aygun M. Comprehensive Endocrine-Metabolic Evaluation of Patients With Alstrom Syndrome Compared With BMI-Matched Controls. J Clin Endocrinol Metab. 2018 Jul 1;103(7):2707-2719. doi: 10.1210/jc.2018-00496.
PubMed 29718281
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocrine Studies in Health and Disease
- ClinicalTrials.gov ID
- NCT00006073
- Acronym / sponsor ID
- 000180
- Conditions
- Endocrine Diseases
- Keywords
- Evaluation, Endocrinology, Hormones, Metabolism, Teaching, Endocrine Disorder
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 3,090 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 19 Jul 2000
- Study completion
- 31 Aug 2016
- First posted
- 14 Jul 2003 (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 healthy normal volunteers and patients with a variety of endocrine disorders to 1) learn more about conditions that affect the endocrine glands (glands that secrete hormones) and 2) train physicians in endocrinology.
Patients with endocrine-related conditions and healthy volunteers of all ages may be eligible for this study.
All participants will have a physical examination medical and history. They may be required to provide blood, saliva or urine samples and undergo ultrasound (using sound waves) or magnetic resonance (using a magnetic field) imaging to visualize internal body structures.
Some healthy adult volunteers will have hormone-stimulating tests to assess endocrine function. These tests measure blood hormone levels before and after injection of a synthetic form of a hormone. A device called a heparin lock, through which the hormone is injected and the blood samples are collected, is placed in a vein in the arm or hand. Blood samples are drawn before the hormone is injected and at various intervals after the injection to measure levels of the hormone. These tests, which last from 1 to 3 hours, may include the following:
- CRH stimulation test corticotropin-releasing hormone is given to test pituitary and adrenal gland function
- ACTH stimulation test adrenocorticotrophic hormone is given to test adrenal gland function
- LHRH stimulation test luteinizing hormone-releasing hormone is given to test pituitary gland function
- TRH stimulation test thyroid-releasing hormone is given to test pituitary and thyroid gland function
- GHRH stimulation test growth hormone releasing hormone is given to measure growth hormone levels.
An oral glucose tolerance test, which is similar to the stimulation tests, may also be done to measure blood glucose (sugar) and insulin levels after drinking a sugary liquid.
Healthy volunteers and patients with a hereditary endocrine disorder and their family members may also be asked to provide a blood sample for genetic studies of inherited endocrine disorders. Patients with endocrine-related disorders may be offered medical or surgical treatment for their disorder.
AcAccess http://turners.nichd.nih.gov/ for additional study publications.
Detailed description
This protocol is designed to allow endocrine-related evaluations of healthy subjects and patients with a variety of endocrine disorders. Healthy subjects may be studied to obtain normative data for endocrine tests involving blood, urine, saliva, ultrasound and magnetic resonance examinations. If not eligible for a specific NICHD research protocol, patients with endocrine-related conditions may be evaluated under the auspices of this protocol to advance the clinical skills of physicians participating in NICHD clinical research and training programs, and to provide stimuli for new clinical research initiatives. Standard, medically-indicated laboratory or radiological studies may be performed to confirm a diagnosis or to aid in the management of the patient. In some cases, the patient will receive medical or surgical treatment for their disorder, according to current clinical practice. The overall purpose of endocrine evaluations under this protocol is to support our clinical training and research missions.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- Up to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy subjects and patients with endocrine-related conditions of all ages are eligible for this protocol. The actual selection of patients most appropriate for clinical training needs will be made by protocol investigators.
- Subjects with disabilities are not formally excluded from the study unless the disability would specifically prevent their participation. If a subject with cognitive impairment wishes to participate, there must be available a family member or other qualified individual holding a durable power of attorney who is able to guide the impaired subject s participation and be an advocate for their interests. This participation is limited to the non-research, clinical training arm of the study.
Key exclusion criteria (0 listed)
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 6 Oct 2017.
- Derived from this study: PubMed 29718281Han JC, Reyes-Capo DP, Liu CY, Reynolds JC, Turkbey E, Turkbey IB, Bryant J, Marshall JD, Naggert JK, Gahl WA, Yanovski JA, Gunay-Aygun M. Comprehensive Endocrine-Metabolic Evaluation of Patients With Alstrom Syndrome Compared With BMI-Matched Controls. J Clin Endocrinol Metab. 2018 Jul 1;103(7):2707-2719. doi: 10.1210/jc.2018-00496.
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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.
Margaret F Keil, C.R.N.P. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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 Endocrine Diseases, 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 0 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 6 Oct 2017. 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 NCT00006073, which also lists 1 linked publication.
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 6 Oct 2017.