Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00529841
Status:
COMPLETED
Last Update Posted:
2015-09-14
First Post:
2007-09-12
Brief Title:
Research Study for Children With Salt Wasting Congenital Adrenal Hyperplasia
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
A Novel Therapeutic Modality for Congenital Adrenal Hyperplasia
Status:
COMPLETED
Status Verified Date:
2015-09
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:
The purpose of this study is to develop a more physiological approach to the management of children and adolescents with salt wasting Congenital Adrenal Hyperplasia
We will administer the glucocorticosteroid via insulin infusion pump to see whether this treatment will improve the serum hormone concentrations
We will administer the glucocorticosteroid via insulin infusion pump to see whether this treatment will improve the serum hormone concentrations
Detailed Description:
The adrenal gland is a small organ of the body It produces very important chemicals called hormones One of these hormones cortisol the stress hormone helps the body fight diseases The other hormone is the aldosterone helps to maintain the normal amount of salt and water in the body The third type of hormones are the androgens or male hormones which cause some of the changes during puberty like the growth of body hair and pimples
The salt wasting Congenital Adrenal Hyperplasia or CAH disease is a disease of the adrenal gland Patients with this disease cannot make cortisol or the aldosterone As a result their body cannot fight diseases and cannot keep normal amounts of salt and water in the body At the same time the gland makes too much of the male hormones which is bad for the body because too much male hormone slows down growth increases the growth of body hair and causes pimples and abnormal period in girls
Patients with this disease have to take medications every day However the treatment does not work very well because usually the patients do not have the right amount of hormone in their body Usually the body gets too much hormone right after taking the pills A couple of hours later the body has too little of the hormones because in the meantime the body gets rid of the medicationThe healthy adrenal gland makes the hormones throughout the day in different amounts The patients with this disease take the medication only a couple of times a day They take the Florinef tablet once a day and the Cortisol tablet two or three times a day The treatment that we use today by mouth cannot copy the natural hormone productions of the adrenal gland Because of this it does not make much of a difference in the patients life
We would like to improve the treatment and find out the effect of a new treatment In this study we will try to imitate the bodys normal hormone production and will give the medication via an insulin pump to see if this treatment method will decrease the male hormones in the blood This study will help us to develop a new and better treatment for children and adolescents
The salt wasting Congenital Adrenal Hyperplasia or CAH disease is a disease of the adrenal gland Patients with this disease cannot make cortisol or the aldosterone As a result their body cannot fight diseases and cannot keep normal amounts of salt and water in the body At the same time the gland makes too much of the male hormones which is bad for the body because too much male hormone slows down growth increases the growth of body hair and causes pimples and abnormal period in girls
Patients with this disease have to take medications every day However the treatment does not work very well because usually the patients do not have the right amount of hormone in their body Usually the body gets too much hormone right after taking the pills A couple of hours later the body has too little of the hormones because in the meantime the body gets rid of the medicationThe healthy adrenal gland makes the hormones throughout the day in different amounts The patients with this disease take the medication only a couple of times a day They take the Florinef tablet once a day and the Cortisol tablet two or three times a day The treatment that we use today by mouth cannot copy the natural hormone productions of the adrenal gland Because of this it does not make much of a difference in the patients life
We would like to improve the treatment and find out the effect of a new treatment In this study we will try to imitate the bodys normal hormone production and will give the medication via an insulin pump to see if this treatment method will decrease the male hormones in the blood This study will help us to develop a new and better treatment for children and adolescents
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 |
|---|---|---|---|
| GCRC 0962 | OTHER | Baylor College of Medicine | None |