Status:
COMPLETED
Comparison of Cortisol Pump With Standard Treatment for Congenital Adrenal Hyperplasia
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Adrenal Insufficiency
Excess Androgen
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
Background: * Congenital adrenal hyperplasia (CAH) is a genetic disorder of the adrenal gland. The adrenal gland is located in the abdomen and produces small amounts of hormones such as cortisol, ald...
Detailed Description
Congenital adrenal hyperplasia (CAH) is a common genetic endocrine disorder, with 21-hydroxylase enzyme deficiency accounting for 95% of the cases. 21-hydroxylase deficiency presents with a spectrum o...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Patients with known classic CAH due to 21-hydroxylase deficiency as evidenced by hormonal and genetic testing
- Male or female patients 18 years or older
- Females must have a negative pregnancy test initially and at all visits. Sexually active females must be using a medically acceptable method of contraception.
- Patients with elevated adrenal androgens (defined as 17-OHP \>1200 ng/dL and androstenedione \>210 ng/dL)
- One or more co-morbidities:\<TAB\>
- Obesity \[body mass index (BMI) greater than 30.0 kg/m(2)\]
- Fatty liver disease; assessed by AST/ALT liver enzyme ratio (AST to ALT ratio \<1 (11)) liver ultrasound or MRI imaging (Steatosis score as previously described)
- Low insulin sensitivity; assessed by the Homeostasis Model Assessment Insulin Resistance (HOMA-IR) method \[HOMA-IR = insulin (micro U/ml) times glucose (mmol/L)/ 22.5\]. Elevated HOMA-IR index is defined as \>2.6 in adults17.
- Osteopenia \[bone mineral density by DEXA (at the spine, hip, or forearm) with T-score of -1 to -2.5) or osteoporosis (bone mineral density by DEXA (at the spine, hip, or forearm) with T-score of \<-2.5\] defined according to World Health Organization (WHO).
- Glucocorticoid-related gastrointestinal side effects (nausea, vomiting, dyspepsia, anorexia, gastritis, peptic ulcer disease and gastric bleeding)
- EXCLUSION CRITERIA:
- Co-morbid conditions requiring daily administration of medications that induce hepatic enzymes or interfere with the metabolism of glucocorticoids
- Females who are pregnant or lactating
- Patients on inhaled or oral steroids given for reasons other than treatment of CAH
- Women who have taken estrogen-containing oral contraceptive pills within 6 weeks of recruitment
- Patients who required stress dose glucocorticoids for an illness within 4 weeks of recruitment
- Patients who changed their glucocorticoid agent within 3 months of recruitment
- Patients who underwent bilateral adrenalectomy
- Co-morbid conditions that could interfere with the ability to comply to the protocol
Exclusion
Key Trial Info
Start Date :
May 6 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2016
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01859312
Start Date
May 6 2013
End Date
December 2 2016
Last Update
December 22 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892