Adrenal Insufficiency Clinical Trial
Official title:
Optimising Steroid Replacement in Patients With Adrenal Insufficiency
Adrenal insufficiency is a condition where the adrenal glands do not produce an adequate
amount of steroid hormones. The aetiology of adrenal insufficiency can be primary or
secondary. Patients will adrenal insufficiency have increased morbidity and mortality. In
recent years there has been concern regarding what is the optimal dose and regimen of steroid
replacement for patients. Unfortunately there is no accurate way of monitoring if a patient
is on too much or too little steroid. We have shown in hypopituitary patients with secondary
adrenal insufficiency that higher doses of hydrocortisone may be harmful. This reason for
this is not fully understood.
In recent years, a modified release hydrocortisone tablet (Plenadren) taken once per day
(unlike conventional immediate release hydrocortisone which requires twice or thrice daily
regimen) has come on the market. This tablet has shown to a have a steroid profile that more
closely resembles normal physiology, avoiding the peak steroid levels that occur during
thrice daily regimens, which may be of importance for improving outcome in adrenal
insufficiency patients. It also shown improved cardiovascular risk factors, glucose
metabolism and quality of life in compared to conventional treatment.
The aim of our study is to assess the effect of hydrocortisone therapy on how the body uses
and breaks down (metabolises) steroids. This will be done by several different research
methods: by measuring markers of steroid action and metabolism in blood, urine and within the
fat tissue under the skin in the abdomen. These results will be compared in the same patient
while on their usual hydrocortisone and after switching to modified release hydrocortisone
for 12 weeks, and to results from a normal healthy control group who are not on steroid
replacement.
This will be the first study to assess the impact of this new modified release hydrocortisone
in relation to tissue steroid metabolism. The results will potentially help us to improve the
treatment of patients with steroid deficiency and reduce the side effects seen in these
patients.
Status | Enrolling by invitation |
Enrollment | 60 |
Est. completion date | December 2019 |
Est. primary completion date | September 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Male or female patients = 18years of age with Primary Adrenal Insufficiency (Addison's disease) confirmed on biochemical testing. - Male or female patients = 18years of age with ACTH deficiency defined by a stimulated peak cortisol in response to insulin-induced hypoglycaemia or short synacthen testing <400 nmol/l, with known organic pituitary disease, and no adjustment in hormone replacement for at least 3 months prior to study entry. - Signed informed consent to participate in the study Exclusion Criteria: - Age < 18 years - Patients with acute medical or surgical illness - Patients with advanced cardiac/pulmonary disease - Patients with a terminal illness - Patients on glucocorticoids for purposes other than ACTH deficiency - Patients on agents that interfere with corticosteroid metabolism |
Country | Name | City | State |
---|---|---|---|
Ireland | Adelaide and Meath Hospital incorporating the National Childrens Hospital | Dublin |
Lead Sponsor | Collaborator |
---|---|
The Adelaide and Meath Hospital, incorporating The National Children's Hospital |
Ireland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Global corticosteroid metabolism | Urinary steroid metabolite profiles. | At baseline and after 12 weeks of Plenadren(intervention) treatment | |
Primary | Adipose tissue corticosteroid metabolism | Cortisol generation profile using adipose tissue microdialysis catheter | At baseline and after 12 weeks of Plenadren(intervention) treatment | |
Primary | Hepatic corticosteroid metabolism | Serum Cortisol generation profile | At baseline and after 12 weeks of Plenadren(intervention) treatment | |
Secondary | Quality of Life questionnaires | At baseline and after 12 weeks of Plenadren(intervention) treatment | ||
Secondary | Potential biomarkers for adequacy of hydrocortisone replacement | Gene and protein expression of adipose tissue samples | At baseline and after 12 weeks of Plenadren(intervention) treatment |
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