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| Sponsored by: |
Baylor College of Medicine |
|---|---|
| Information provided by: | Baylor College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00529841 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Adrenal Hyperplasia, Congenital |
Drug: Hydrocortisone sodium acetate |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | A Novel Therapeutic Modality for Congenital Adrenal Hyperplasia |
| Estimated Enrollment: | 10 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | July 2008 |
| Estimated Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Subcutaneous administration of medication via insulin pump
|
Drug: Hydrocortisone sodium acetate
Subcutaneous administration of medication via insulin pump
|
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 medication.The 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 patient's 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 body's 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.
Eligibility| Ages Eligible for Study: | 3 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Criteria for study termination: If the subject's parents are unable to manage/operate the pump, the subject will be withdrawn from the study.
Contacts and Locations| Contact: Andrea E Balazs, MD | 832-822-3773 | aebalazs@texaschildrenshospital.org |
| United States, Texas | |
| BCM, Texas Children's Hospital Clinic and General Clinical Research Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Andrea E Balazs, MD 832-822-3773 aebalazs@texaschildrenshospital.org | |
| Principal Investigator: Morey W Haymond, MD | |
| Sub-Investigator: Andrea E Balazs, MD | |
| Principal Investigator: | Morey W Haymond, MD | Baylor College of Medicine |
More Information
| Responsible Party: | Baylor College of Medicine ( Morey W.Haymond MD Professor of Pediatrics;Chief. Endocrine and Metabolism Section; Vice Chairman for Research ) |
| Study ID Numbers: | H-19704, GCRC # 0962 |
| Study First Received: | September 12, 2007 |
| Last Updated: | March 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00529841 |
| Health Authority: | United States: Institutional Review Board |
|
Salt Wasting Congenital Adrenal Hyperplasia Subcutaneous Hydrocortisone |
|
Hydrocortisone Metabolic Diseases Cortisol succinate Gonadal Disorders Adrenogenital Syndrome Adrenal Gland Diseases Endocrine System Diseases Adrenocortical Hyperfunction Sex Differentiation Disorders Insulin |
Metabolism, Inborn Errors Hyperplasia Adrenal hyperplasia Genetic Diseases, Inborn Adrenal Hyperplasia, Congenital Hydrocortisone acetate Endocrinopathy Epinephrine Metabolic disorder |
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Anti-Inflammatory Agents Pathologic Processes Therapeutic Uses Steroid Metabolism, Inborn Errors Pharmacologic Actions |
