Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006278
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-09-14
Brief Title:
Study of Cushings Syndrome Not Related to ACTH Production
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Molecular and Cellular Etiology of ACTH-Independent Adrenal Disease
Status:
COMPLETED
Status Verified Date:
2002-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to provide information about the cause of two unusual types of Cushings syndrome and to evaluate quality of life before and after cure of the disease In Cushings syndrome the adrenal glands produce too much of the hormone cortisol This often causes weight gain skin changes bruising and stretch marks and mood changes such as irritability easy crying and depression Adrenocorticotrophic hormone ACTH normally regulates cortisol production when cortisol is low ACTH rises stimulating the adrenals to produce more cortisol and when cortisol is high ACTH levels fall In two forms of Cushings syndrome however the adrenal glands produce cortisol even when ACTH is low
Patients 18 years of age and older with Cushings syndrome not related to ACTH production may participate in this study Candidates will be have a history and physical examination electrocardiogram urine blood and saliva tests and a computerized tomography CT scan of one or both adrenal glands They will fill out questionnaires on their disease symptoms quality of life and on basic information about themselves such as marital status education level place of residence etc Finally they will have a corticotropin-releasing hormone CRH test to confirm that they have the form of Cushings syndrome under study in this protocol This test involves collecting blood samples at intervals before and after administration of sheep CRH to measure cortisol and ACTH levels
Participants will undergo 3 to 7 days of testing to determine if their cortisol level rises after taking certain medicines or eating certain foods These foods and medicines chosen to mimic or stimulate substances already in the body are glucagon ACTH gonadotropin-releasing hormone vasopressin thyrotropin-releasing hormone and a mixed meal consisting of a protein carbohydrate and fat usually chicken breast and a milkshake-like drink Blood will be collected at intervals before and after taking the food or medicine to measure cortisol blood levels Blood will also be collected while the patient is in a standing position and while lying in bed because changes in posture can cause substances in the body to increase or decrease Depending on the individuals response to these tests additional tests may be done with insulin glucose luteinizing hormone and follicle-stimulating hormone
Patients who do not respond to these substances will undergo adrenalectomy surgery to remove one or both adrenal glands This is standard treatment for this type of Cushings syndrome It is usually done by laparoscopy in which air is injected into the abdomen through tubes inserted through a small incision enabling the surgeon to see the organs and remove the gland Part of the removed tissue will be examined to learn about what causes this type of Cushings syndrome it may also be used for genetic studies related to the disease Patients will stay in the hospital for a week to 10 days for observation and treatment and then will be discharged to the care of their own doctor They will continue to complete the quality of life questionnaire every 3 months for 2 years
Patients with normal adrenal glands who are participating in National Cancer Institute studies and are scheduled for adrenalectomy as part of their standard treatment will also be recruited for this study to serve as controls The patients will have a 24-hour urine collection and part of the adrenal gland tissue removed for their treatment will be used for research purposes of this study possibly including genetic study
Patients 18 years of age and older with Cushings syndrome not related to ACTH production may participate in this study Candidates will be have a history and physical examination electrocardiogram urine blood and saliva tests and a computerized tomography CT scan of one or both adrenal glands They will fill out questionnaires on their disease symptoms quality of life and on basic information about themselves such as marital status education level place of residence etc Finally they will have a corticotropin-releasing hormone CRH test to confirm that they have the form of Cushings syndrome under study in this protocol This test involves collecting blood samples at intervals before and after administration of sheep CRH to measure cortisol and ACTH levels
Participants will undergo 3 to 7 days of testing to determine if their cortisol level rises after taking certain medicines or eating certain foods These foods and medicines chosen to mimic or stimulate substances already in the body are glucagon ACTH gonadotropin-releasing hormone vasopressin thyrotropin-releasing hormone and a mixed meal consisting of a protein carbohydrate and fat usually chicken breast and a milkshake-like drink Blood will be collected at intervals before and after taking the food or medicine to measure cortisol blood levels Blood will also be collected while the patient is in a standing position and while lying in bed because changes in posture can cause substances in the body to increase or decrease Depending on the individuals response to these tests additional tests may be done with insulin glucose luteinizing hormone and follicle-stimulating hormone
Patients who do not respond to these substances will undergo adrenalectomy surgery to remove one or both adrenal glands This is standard treatment for this type of Cushings syndrome It is usually done by laparoscopy in which air is injected into the abdomen through tubes inserted through a small incision enabling the surgeon to see the organs and remove the gland Part of the removed tissue will be examined to learn about what causes this type of Cushings syndrome it may also be used for genetic studies related to the disease Patients will stay in the hospital for a week to 10 days for observation and treatment and then will be discharged to the care of their own doctor They will continue to complete the quality of life questionnaire every 3 months for 2 years
Patients with normal adrenal glands who are participating in National Cancer Institute studies and are scheduled for adrenalectomy as part of their standard treatment will also be recruited for this study to serve as controls The patients will have a 24-hour urine collection and part of the adrenal gland tissue removed for their treatment will be used for research purposes of this study possibly including genetic study
Detailed Description:
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 Cushings syndrome However some patients with hypercortisolism of Cushings 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 Cushings syndrome adrenal adenomas and massive macronodular adrenal disease MMAD
Patients with low levels of ACTH and Cushings 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
Patients with low levels of ACTH and Cushings 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-CH-0178 | None | None | None |