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.
This is a prospective, cross-over study. This study cannot be blinded or placebo controlled
due to the risk of adrenal crisis in the study population with primary and secondary adrenal
insufficiency.
The aim of study is to assess the effect of immediate release and modified release
hydrocortisone therapy on corticosteroid metabolism and 11-HSD1 in vivo (by assessment of
urine metabolites and liver/ adipose tissue metabolism) by using several translational
research approaches. This will also be compared to normal healthy controls to assess which
treatment protocol is most physiological.
Study Objectives
- To assess the effect of changing to modified release hydrocortisone therapy on global
corticosteroid metabolism as assessed by urinary steroid metabolite profiles.
- To assess the effect of changing to modified release hydrocortisone therapy on adipose
tissue corticosteroid metabolism and action
- To assess the effect of changing to modified release hydrocortisone on hepatic
corticosteroid metabolism.
- To assess the effect of changing to modified release hydrocortisone therapy on patient
quality of life (QoL) as assessed through validated QoL questionnaires.
- To compare results to normal healthy controls to assess which treatment protocol is most
physiological.
- To assess potential biomarkers for adequacy of hydrocortisone replacement therapy.
Patients will switch from their usual conventional immediate release hydrocortisone to daily
dose equivalent of modified release hydrocortisone (Plenadren®) for 12 weeks.Other hormone
replacement therapy regimens will not be adjusted during the study period.
Research laboratory measurements will be performed at baseline and 12 weeks of modified
release hydrocortisone. At the end of the intervention treatment period, the patients will be
shifted to their usual hydrocortisone treatment and will be followed at the outpatient clinic
according to the directives of the clinic.
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