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The Molecular and Cellular Etiology of ACTH-Independent Adrenal Disease

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Cushing's Syndrome, Healthy

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Trial Information

The Molecular and Cellular Etiology of ACTH-Independent Adrenal Disease

In healthy individuals, ACTH is the major stimulus for cortisol production and cellular
growth of the adrenal cortex. Normal or elevated ACTH levels can amplify this stimulus,
leading to hypercortisolism and growth of the adrenal gland, a clinical condition recognized
as Cushing's syndrome. However, some patients with hypercortisolism of Cushing's syndrome
have suppressed rather than normal or high levels of ACTH. This pilot study seeks to better
understand the apparently autonomous nature of hypercortisolism in two benign causes of
Cushing's syndrome, adrenal adenomas and massive macronodular adrenal disease (MMAD).

Patients with low levels of ACTH and Cushing's syndrome will undergo routine tests to
confirm that they have hypercortisolism, low ACTH, and adenoma or MMAD on CT scans. They
will fill out a questionnaire about quality of life. They will also undergo 3-7 days of
research testing with a variety of agents to investigate whether these agents increase
cortisol. Following this, patients will be scheduled for adrenalectomy at the NIH. This is
the standard treatment for these conditions. The abnormal tissue obtained at surgery will
be used for laboratory studies to evaluate whether the same or other agents may be the cause
of excess cortisol production.

After surgery, patients will be discharged to the care of their local health care provider,
but will continue to fill out questionnaires on the quality of life for two years.

Inclusion Criteria


Patients with normal adrenal glands will be recruited from those studied under NCI

They will not have taken suppressive doses of glucocorticoids for 12 months, and will not
have any known adrenal pathology, either of the cortex or medulla.

They will not have Von-Hippel Lindau syndrome.


Will be aged 18 or older;

Will have plasma ACTH levels of 10 pg/mL or less;

Will have an outside physician who will follow them after surgery.

Must not weigh greater than 380 pounds. These patients are unable to undergo CT scans.

Must not have a CT scan showing normal or atrophic bilateral adrenal glands.

Must not have a CRH test showing a response as defined above. The diagnosis of these
patients will need further evaluation.

Must not have any condition that would preclude surgery, including advanced heart failure,
significant coronary artery disease, severe pulmonary disease.

Must not have a hematocrit less than 30 or research blood withdraw greater than 450 mL in
the previous six weeks.

Must not be pregnant.

Must not have a history of angina or known coronary artery disease, because these patients
are at risk for exacerbation during the vasopressin test.

The SF-36 questionnaire will only be given to individuals who speak and read English
fluently. Patients may participate in the remainder of the study, however, if they do not
meet this criterion.

Type of Study:


Study Design:



United States: Federal Government

Study ID:




Start Date:

September 2000

Completion Date:

September 2002

Related Keywords:

  • Cushing's Syndrome
  • Healthy
  • Cushing's Syndrome
  • Adrenal Glands
  • Proteomics
  • Cortisol
  • Cushing Syndrome



National Institute of Child Health and Human Development (NICHD) Bethesda, Maryland  20892