View clinical trials related to Adrenal Insufficiency.
Filter by:The major goal of this study is to determine the incidence of adrenal insufficiency in patients with endogenous Cushing syndrome receiving osilodrostat treatment combined with a replacement of glucocorticoid (block-and-replace approach). The investigators are also evaluating new biomarker steroids to reflect adequate osilodrostat dosing, the durability and safety, and clinical improvement during treatment.
The main aim of this study is to assess the role of 11-deoxycortisol as surrogate marker of Residual adrenal function. 11-deoxycortisol levels will be assessed in all recruited patients
Patients with liver cirrhosis (LC) often exhibit fatigue, poor oral intake, and abdominal discomfort, which are the symptoms that are also shown in subjects with adrenal insufficiency (AI). Controversy exists upon over-diagnosis of adrenal insufficiency in patients with LC, because decreased albumin and/or cortisol binding protein lower total cortisol levels while free cortisol increases/or is preserved. The investigators assumed that measuring salivary cortisol or direct free cortisol using mass-spectrometry would provide a more accurate level of cortisol in LC patients. 50 patients with LC will be recruited and undergo a rapid ACTH stimulation test and their blood/ saliva will be collected and analyzed. The difference between serum free cortisol and total cortisol, as well as between salivary cortisol and total cortisol will be investigated to find the optimal way to diagnose AI in LC patients.
The braking of the corticotropic axis is well established during the induction phase of superpotent topical corticosteroid therapy (clobetasol propionate) in bullous pemphigoid (BP). But the evolution of the corticotropic axis in the following months, especially during the tapering of topical steroids has never been studied. The objective of this study is to evaluate the prevalence of adrenal insufficiency during the topical corticosteroid therapy tapering in patients treated according to current recommendations. The secondary objectives of the study are : - to evaluate the presence of other clinico-biological signs of adrenal insufficiency (hypotension, hypoglycemia and/or hyponatremia) - to compare the characteristics of patients with adrenal insufficiency to those without in order to identify potential risk factors for adrenal insufficiency in BP.
Cortisol is an essential for life hormone secreted in a pulsatile pattern on a diurnal rhythm. Given the complexity of cortisol secretion on a circadian rhythm with pulsations, current methods of cortisol measurement have limitations. Therefore, a non-invasive and ambulatory method would be useful to measure cortisol levels in real-time. The main aim of the study is to compare cortisol levels across biological fluids (sweat, saliva, interstitial fluid, and blood) in order to validate in the long term a continuous and non-invasive cortisol measurement device (currently under development).
The present study aims to: 1. Estimate the prevalence of Postural Tachycardia Syndrome and vasovagal syncope among adults patients attend the Internal Medicine Clinic and ICU in period from 11/2022 to 10/2023 2. Detect of causes and the relationship between POTS and vasovagal syncope and serum electrolytes, and serum cortisol.
Rationale: An adrenal crisis is an acute life-threatening event which may occur in patients with adrenal insufficiency. The initial emergency treatment consists of an intramuscular injection with 100 mg hydrocortisone administered by the patient or a bystander. The injection should be administered immediately. Although it is considered life-saving, it is not very patient-friendly, because of the several steps required for reconstitution, the intramuscular injection, the frequent presence of needle phobia, and pain at the injection site. Inhalation of predniso(lo)ne could be a more patient-friendly alternative. Objective: This study investigates the pharmacokinetics of nebulized prednisolone in two different dosages. Study design: Single-center, open-label study Study population: Healthy participants aged 18-75 years. Intervention (if applicable): Healthy volunteers receive a lower dose of nebulized prednisolone (46.75 mg).After a wash-out period of at least one week, each volunteer receives a higher dose of nebulized prednisolone (93.5 mg). Main study parameters/endpoints: To establish the time from nebulizing to maximum prednisolone concentration in serum and the area under the curve of prednisolone. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants are exposed to a single supraphysiological dose of glucocorticoids on two separate occasions. The risk of SAE is very limited. There is a small risk of an AE during blood sampling. If it is demonstrated that therapeutic plasma concentrations of prednisolone can be reached by nebulizing prednisolone, we intend to use the pharmacokinetic data to design and perform a clinical study with a dry-powder micronized prednisone inhalation. This would represent a novel and promising alternative treatment for an adrenal crisis. Patients with adrenal insufficiency could then be offered a much more patient-friendly and reliable alternative for intramuscular hydrocortisone injection.
In this double-blinded randomised placebo-controlled clinical trial, the aim is to determine the effect of supplemental hydrocortisone compared with placebo during mild to moderate physical or mental stress on health related quality of life in patients with polymyalgia rheumatica (PMR)/giant cell arteritis (GCA) on ongoing low-dose prednisolone diagnosed with glucocorticoid-induced adrenal insufficiency. The main emphasis is on fatigue (primary outcome) and daily variation hereof during periods of stress.
Eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus, is a clinical and financial burden to patients if left untreated. Often the natural history of the disease includes development of fibrosis and stricturing of the esophagus, acute food impactions, unplanned emergency room visits, and invasive procedures such as endoscopy. Currently there are no Food and Drug Administration (FDA) approved medications for the treatment of EoE. As such, pharmacologic options approved for use in asthma are used for treatment of EoE and include proton pump inhibitors and swallowed topical steroids. These medications are prescribed chronically as EoE is considered a lifelong disease. Chronic administration of exogenous steroids, when given in inhaled or systemic preparations, can lead to adrenal insufficiency (AI). AI is seen in 7.8% of patients receiving chronic inhaled steroids and 48.7% of patients receiving chronic systemic steroids. The administration of steroids in EoE is unique, as patients typically swallow topical preparations of the drug. The risk of secondary AI from taking swallowed topical steroids is currently unknown, as there has been no study in an adult population assessing this risk as a primary endpoint. Pediatric studies of patients with EoE have shown the risk of AI from swallowed topical steroids to be 5-10%. Based on the risk of AI with inhaled steroids (7.8% prevalence) and the prevalence of AI from swallowed topical steroids in pediatric populations (5-10%), we hypothesize that the risk with swallowed topical steroids is >5%. This could warrant consideration of screening given the potentially serious consequences of undiagnosed AI. To address this hypothesis, this project aims to define the prevalence of developing AI in adults with EoE taking swallowed topical steroids and compare that prevalence to a similar control population of adults with EoE who are taking proton pump inhibitors.
Cortisol, a glucocorticoid (GC) hormone secreted from the adrenal glands, is essential for survival. Cortisol also possesses anti-inflammatory actions and GC formulations (prednisolone) are used to treat many inflammatory diseases and conditions. Indeed, three percent of the Danish population (≈ 180.000 individuals) redeems at least one prescription of synthetic GC per year and at least 20,000 patients annually discontinue GC treatment. Pharmacological GC therapy suppresses endogenous cortisol production and thereby induce relative adrenal insufficiency (GIA). The risk of GIA as determined by the adrenal corticotrophic hormone (ACTH) stimulation test has previously been reported to ≈ 25 %, but testing after GC treatment is not routinely performed. Indeed, we have new and unpublished but persuasive evidence to suggest that the risk of GIA after planned cessation of prednisolone treatment for polymyalgia rheumatic (PMR) or giant cell arteritis (GCA) is substantially lower, probably 2%. The reason for this discrepancy is undoubtedly selection bias in the previous publications and the use of inaccurate cortisol assays. At the same time, however, we observed that 25% exhibited pronounced symptoms of adrenal insufficiency based on a questionnaire specific for detecting symptoms of adrenal insufficiency, the so-called AddiQoL-30. Concomitantly, the basal cortisol levels in the same group were significantly lower as compared to the group, who exhibited milder or no symptoms attributable to adrenal insufficiency. This observation aligns with the clinical experience that PMR/GCA patients often complain of fatigue after planned cessation of prednisolone treatment. This often occurs in the absence of objective symptoms or signs of residual PMR/GCA disease activity. The scenario has been designated as "the steroid withdrawal syndrome". We argue, that this may represent a state of relative adrenal insufficiency prompted by long term, high dose prednisolone treatment. The proper way to tackle this clinical conundrum is to perform a proper randomized trial, which so far has not been conducted. Therefore, we will perform the first placebo-controlled randomised controlled trial (RCT) in patients with PMR and GCA after planned cessation of GC treatment. We argue that neither watchful waiting nor routine hydrocortisone replacement are infallible. Our study will be the first evidence-based guidance and aid to GIA patients and thus meet an important need for many thousand patients.