Study of Endocrine-Related Conditions and Physiology

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 internal medicine endocrinology training programs. The research-directed
evaluations may include blood, feces, saliva, or urine samples or evaluation of 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 is to support our clinical training or
research missions. Future small pilot studies may be performed to investigate certain
endocrine questions; these will be presented to the IRB as they arise.

- INCLUSION CRITERIA:

1. Age 18 years or greater.

2. The possible disorder of the patient subjects must complement the case-mix in the
IETP, as determined by the Principal Investigator. A log will be used to assure
that the training needs of the teaching protocols are being met.

3. Pregnant women/fetuses are not an intended cohort for the study the study is not
intended to explore specific aspects of pregnancy or fetal development. However,
pregnant women may be enrolled into the protocol for standard evaluation and/or
care that has the prospect of providing direct benefit. They may also provide
biospecimens for research studies. Pregnancy tests will be performed

before any drugs are given or imaging is performed, on all women of reproductive
age (18 -50 years) if they have had menses in the last year. In general, testing
would be limited to minimal risk tests, such as blood withdrawal, study of urine,
feces or saliva, use of provocative tests that must be performed to establish a
diagnosis, and are considered safe for both mother and fetus, and/or imaging that
is both essential and safe, such as ultrasound or non-contrast MRI. No
radioactive material or radiation will be administered.

4. NIH employees are eligible to participate. Employee enrollment is not anticipated
in this protocol, but if an employee wants to be enrolled in the study with the
prospect of direct benefit in accordance with the NIH HRPP SOP 14F they may be
enrolled. However, the Principal Investigator will take the following steps to
ensure that there are adequate protections in place to protect the
confidentiality of

employee health information and minimize any pressure or discomfort of the employee with
the consent process: 1. A member of the research team will provide the NIH Information
Sheet on Employee Research Participation, and NIH policy 2300-630-3 to employees who are
considering enrolling in research to help them understand NIH requirement and possible
consequences. 2. If a member of the research team is the supervisor of the
employee-subject, an independent person (e.g. bioethics staff) will monitor the consent
process. 3. The Principal Investigator will require that study staff who may have contact
with sensitive data about a co-worker or subordinate complete the Just-in-Time CITI course
Biomedical Vulnerable Subjects-Workers/Employees.

EXCLUSION CRITIERIA:

1. Unstable patients and patients with severe organ failure, or those with a condition or
medical treatment that may affect/limit the endocrine work-up and exhaust Clinical
Center, NIDDK and/or NICHD resources will be excluded if appropriate. Decisions will
be made on a case by case basis by the investigators. For example, there is a weight
limit for the interventional radiology table used for venous

sampling.

2. Inability of a subject to adhere to a proposed schedule of visits.

3. Because there is a potential for research studies under this protocol, individuals
must be able to provide informed consent. The inability to provide informed consent
will be an exclusion criterion. However, if patients have previously given consent,
and become unable to provide informed consent, they will continue to be seen for
ongoing clinical care only. 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.