Clinical Trials for Addison Disease

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Addison Disease from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 42
• Recruiting: 5
• Active, not recruiting: 1
• Completed: 23
• Other: 13

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT04569149 — Primordial Dwarfism Registry

The goal of this registry is to collect information on individuals with forms of microcephalic primordial dwarfism as well as related conditions. The study team hopes to learn more about these conditions and improve the care of people with them by establishing this registry.

NCT01793168 — Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford

CoRDS, or the Coordination of Rare Diseases at Sanford, is based at Sanford Research in Sioux Falls, South Dakota. It provides researchers with a centralized, international patient registry for all rare diseases. This program allows patients and researchers to connect as easily as possible to help advance treatments and cures for rare diseases. The CoRDS team works with patient advocacy groups,…

NCT05368090 — Endoscopic Ultrasound-guided Radiofrequency Ablation in Primary Aldosteronism

In this study, the investigators will perform endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) treatment of left-sided adrenal tumours in patients with primary aldosteronism (PA) and in patients with mild autonomous cortisol secretion (MACS). Four different study groups will all receive EUS-RFA of left-sided adrenal tumours. Clinical and biochemical outcome as well as procedural s…

NCT04885179 — SPL Insufficiency Syndrome (SPLIS)/NPHS14: a SPLIS Observational Study and Patient Registry (International)

This protocol aims to gather information about sphingosine phosphate lyase insufficiency syndrome (SPLIS), also known as NPHS14, and to create a SPLIS patient registry. Medical records, radiological and pathology results, blood test results, and genetic information will be collected. Samples of blood, cheek cells, urine and stool may be collected for analysis. If a skin biopsy has been performe…

NCT06669949 — Natural History of Sphingosine Phosphate Lyase Insufficiency Syndrome (SPLIS)

This is a prospective longitudinal natural history study with a retrospective cross-sectional arm aimed at determining the natural history of sphingosine phosphate lyase insufficiency syndrome (SPLIS), a recently recognized inborn error of metabolism. The central hypothesis is that age of onset, other disease features, and disease biomarkers will be predictive of quality of life (QOL) and survi…

Active, Not Recruiting

NCT03793114 — Screening and Stimulation Testing for Residual Secretion of Adrenal Steroid Hormones in Autoimmune Addison’s Disease

In autoimmune adrenal insufficiency, or Addison’s disease (AD), the immune system attacks the adrenal cortex. As a result, the adrenal cells producing hormones such as cortisol and aldosterone are destroyed, leaving the body with insufficient levels to meet its needs. The common perception is that upon diagnosis of Addison’s disease, basically all adrenal hormone production has ceased.

There h…

Not Yet Recruiting

NCT04252001 — Growing up With the Young Endocrine Support System (YESS!)

Transition from paediatric to adult endocrinology is a challenge for adolescents, families and doctors. Up to 25% of young adults with chronic endocrine disorders are lost to follow-up (‘drop-out’) once the young adult moves out of paediatric care. Non-attendance and sub-optimal medical self-management can lead to serious and expensive medical complications. In a pilot study, adolescents sugges…

NCT07367425 — Risks of Ramadan Fasting in Patients With Primary Adrenal Insufficiency Treated With Prednisolone.

In primary adrenal insufficiency (PAI), there is a risk of hypoglycemia and dehydration. These risks seem to be increased during intermittent fasting. A previous study in patients with PAI treated with hydrocortisone at a dose of 20 mg/day showed that the prevalence of hypoglycemia was as high outside (63%) as during Ramadan fasting (71%), and that there was no risk of dehydration. We propose t…

NCT07413874 — Telehealth Music Therapy for Adults With Endocrine Disorder and Depression

The goal of this clinical trial is to explore if a telehealth music therapy intervention helps with quality of life, depression symptoms, anxiety symptoms. It will also explore the participants’ relationship to music. The main questions it aims to answer are:

• Refine and tailor the music therapy intervention to fit the specific needs of adults living with an autoimmune disease and depression….

Completed Trials

NCT00001180 — Dose Response Relationship for Single Doses of Corticotropin Releasing Hormone (CRH) in Normal Volunteers and in Patients With Adrenal Insufficiency

Corticotropin Releasing Hormone (CRH) is a hypothalamic hormone made up of 41 amino acids. Amino acids are proteins that when combined make up different substances, like hormones. The order of amino acids in CRH, has been determined, meaning that the hormone can now be synthetically reproduced in a laboratory setting.

When CRH is released from the hypothalamus it stimulates the pituitary gland…

NCT03941184 — Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity

This case control study aims to determine whether spontaneous coronary artery dissection (SCAD) is associated with autoimmune diseases and to update the incidence of SCAD in a population-based cohort.

NCT00004313 — Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone Replacement for Primary Adrenal Insufficiency

OBJECTIVES:

I. Determine the efficacy of dehydroepiandrosterone (DHEA), an androgen replacement hormone, for patients with primary adrenal insufficiency (Addison’s disease).

NCT00688987 — The Hypothalamic-Pituitary-Adrenal (HPA) Axis as an Effector System in Weight Regulation

Replacing glucocorticoid in a dose dependent manner (including doses within the physiological range) to subjects with adrenal insufficiency will increase visceral fat accumulation independently of total fat mass.

NCT00442390 — Metabolic Effects of Acute Cortisol Withdrawal in Adrenal Failure

Effects of adrenal steroids is generelly drawn from studies of hypercortisolism. The effects of physiological cortisol substitution and withdrawal is studied and related to the clinical syndrome of adrenal insufficiency.

NCT00444119 — Survey in Patients With Chronic Adrenal Insufficiency in Germany

The purpose of this survey is to assess patients with chronic primary or secondary adrenal failure regarding subjective health status, incidence and causes of adrenal crisis, hormone replacement regimens and concomitant endocrine or non endocrine disease.

NCT00415701 — Effect of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery

The purpose of this study is to evaluate the effect of a single dose of etomidate for patients undergoing cardiac surgery with the use of cardiopulmonary bypass (CPB) on post-CPB adrenocortical responsiveness, on requirements of hemodynamic support, and on use of intensive care resources.

NCT00251836 — Adrenal Function After Living Kidney Donation

The success of kidney transplantation is hampered by the shortage of organs. One attractive strategy is the use of kidneys from living donors. During the donor operation the kidney artery, kidney vein and ureter have to be interrupted as far as possible from the kidney to have sufficient length for the reconnection of these structures in the transplant operation.

An adrenal gland is situated a…

NCT00915343 — Once-daily Oral Modified Release Hydrocortisone in Patients With Adrenal Insufficiency

This is a randomised, controlled, open, two-armed, two-period cross-over, multi-centre phase II/III study to assess the safety, tolerability and pharmacokinetics of once-daily oral modified-release hydrocortisone in comparison to conventional thrice-daily oral hydrocortisone tablets in patients with adrenal insufficiency

NCT01271296 — Effects and Interactions of Liquorice and Grapefruit on Glucocorticoid Replacement Therapy in Addison’s Disease

Addison’s disease is a rare disease, wherein the adrenals can not produce sufficient steroid hormones (cortisol and aldosterone). Patients with Addison’s disease report impaired subjective health status, and they have increased all-cause mortality. Conventional therapy is by oral replacement of glucocorticoid and mineralocorticoid hormones, but this strategy imperfectly mimic the diurnal cortis…

NCT00975078 — Test Predicting Adrenal Insufficiency in Volunteers Under Prednisone Treatment

Suppression of the adrenal function is a common, potentially dangerous and unpredictable consequence of short term high dose glucocorticoid treatment. Identification of patients at risk would be of high clinical importance. The investigators hypothesized that the dexamethasone-suppression-test predicts the subsequent development of corticosteroid induced adrenal insufficiency.

NCT01063569 — Glucocorticoid Treatment in Addison’s Disease

Addison’s disease is a rare condition which in most cases is caused by autoimmune destruction of the adrenals, leading to deficiency of cortisol, aldosterone and adrenal androgens. Unrecognized the disease is life threatening, but with proper treatment patients can live near normal lives.

The conventional glucocorticoid replacement therapy renders the cortisol levels unphysiological, which may…

NCT01371526 — Revival of Stem Cells in Addison’s Study

Autoimmune Addison’s disease (AAD) is a rare and debilitating disease in which an autoimmune attack progressively destroys the adrenal cortex. Untreated it is universally fatal and treated people are absolutely dependent upon steroid medications lifelong, with a consequent excess in morbidity and mortality. A key feature of the adrenal cortex is that its cells are responsive to changes in circu…

NCT01452893 — Counterregulatory Hormone Production in Adrenal Insufficiency and Diabetes Type I

Patients with adrenal insufficiency also exhibit an adrenomedullary dysfunction. Furthermore, patients who suffer from both, adrenal insufficiency and type I diabetes more frequently report hypoglycemia, particularly after strenuous activities. The study investigates the counter regulatory hormonal response to physical stress and the impact on cognitive function in subjects with and without Add…

NCT01450930 — Pharmacokinetics of Hydrocortisone After Subcutaneous Administration in Chronic Adrenal Insufficiency

Patients with chronic adrenal insufficiency need to adapt their hydrocortisone replacement dose in conditions of physical or psychological stress to prevent life threatening adrenal crisis. In cases of more severe impairment or unsecure gastrointestinal absorption (e.g. gastroenteritis, severe infectious disease), parenteral administration of the hydrocortisone dose is crucial. The study is con…

NCT03426319 — Cardiovascular Status in Adrenal Insufficiency

Within this trial, the cardiovascular status and metabolic profile of patients with chronic primary adrenal insufficiency is evaluated.

NCT02277587 — Dual RElease Hydrocortisone Versus conventionAl Glucocorticoid replaceMent Therapy in Hypocortisolism (DREAM)

This is a randomized, controlled, open, three-armed, multi-centre study designed to compare the effects of dual-release hydrocortisone preparations versus conventional glucocorticoid therapy on anthropometric parameters, metabolic syndrome, infectious, immunological profile, cardiovascular system, bone mass and quality of life in patients affected by primary or secondary adrenal insufficiency.

NCT02096510 — Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal Hyperplasia

The aim of this study is to compare the effects of tablet treatment, circadian and combined circadian and ultradian subcutaneous hydrocortisone infusion on steroid metabolism and tissue responses to therapy.

NCT02152553 — Biomarker(s) for Glucocorticoids

The investigators have shown that patients with adrenal insufficiency (Addison’s disease), a rare disorder, have doubled the expected mortality rate in Sweden despite Standard of Care glucocorticoid (GC) replacement. One % of the Swedish population are, however, receiving GCs for inflammatory diseases, but management is empirical and adjusted to underlying disease activity. The desired anti-inf…

NCT02689960 — Vaginal Prednisone Administration for Prevention of Adrenal Crisis

Patients with chronic adrenal insufficiency need to adapt their glucocorticoid replacement dose in conditions of physical or psychological stress to prevent life threatening adrenal crisis. In cases of more severe impairment or unsecure gastrointestinal absorption (e.g. gastroenteritis, severe infectious disease), rapid and highly dosed administration of glucocorticoids is crucial. The study is…

NCT03210545 — A Study of Markers of Glucocorticoid Effects in Patients With Addisons Disease (DOSCORT)

DOSCORT is a 2-dose, cross-over study primarily aiming to identify and validate novel biological markers (biomarkers) of glucocorticoid effect in the human body. Patients with Addison´s disease, primary adrenal insufficiency, with life-long glucocorticoid replacement therapy will undergo 2 treatment periods where their usual hydrocortisone treatment will be replaced with betamethasone in physio…

NCT05222152 — Chronocort Versus Plenadren Replacement Therapy in Adults With Adrenal Insufficiency

This study is a double-blind, double-dummy, two-way cross-over, randomised, Phase II study to be conducted at approximately 6 investigational sites in 2 countries. The study will compare the efficacy, safety and tolerability of twice daily Chronocort, a modified-release hydrocortisone, with once daily Plenadren, a modified-release hydrocortisone, over a treatment period of up to 2 months in par…

NCT06299020 — Risks of Intermittent Fasting in Patients With Primary Adrenal Insufficiency

In primary adrenal insufficiency, there is an increased risk of hypoglycaemia and dehydration. These risks have been little studied particularly during intermittent fasting. The present study aimed to assess these risks in a prospective study of 30 subjects with primary adrenal insufficiency. Patients will undergo a clinical examination, blood sampling and continuous glucose monitoring for four…

Other (Withdrawn)

NCT00485186 — Gene Polymorphisms Influencing Steroid Synthesis and Action

The extend of steroid biosynthesis and action is mainly dependent on underlying genetic polymorphisms and gene mutations. These sequence variations in multiple genes involved in steroid biosynthesis and action cause different diseases (for example congenital adrenal hyperplasia or disorders of sex development). In addition, sequence variations in several other genes may influence the severity o…

Other (Terminated)

NCT01053754 — Optimization of the Evaluation of the Adrenal Function After Discontinuation of a Prolonged Therapy With Corticosteroids

The study (forward-looking and opened) will concern 70 subjects having had a systemic prolonged treatment with corticosteroids for intestinal chronic inflammatory disease, recruited in the services of gastroenterology and endocrinology of the North Hospital of Marseille (France). The primary objective of the study is to estimate a new test, the “long” synacthen stimulation test, using an IM inj…

Other (Unknown)

NCT01657123 — Exercise Capacity and Recovery in Addison’s Disease

Exposure to stress alters the activity of the adrenomedullary, adrenocortical and sympathetic nervous system, depending on the type and intensity of the stressor. Physical exercise represents a stress condition influencing many systems in the body. Given a workload of at least 70-85% of Vo2max, exercise is a potent stimulus of the hypothalamic-pituitary-adrenal (HPA)-axis. The increased endogen…

NCT01840189 — Continuous Subcutaneous Hydrocortisone Infusion In Addison’s Disease and Type 1 Diabetes

The conventional glucocorticoid replacement therapy in primary adrenal insufficiency (Addison’s disease) renders the cortisol levels unphysiological, which may cause symptoms and long-term complications.

The majority of Addison’s patients have other organ-specific autoimmune disease, which poses challenges to the replacement therapy. Of particular interest is the combination of Addison’s disea…

NCT01847690 — Effect of Cortisol on Physical Exertion in Patients With Primary Adrenal Failure

The conventional glucocorticoid replacement therapy in primary adrenal insufficiency- Addison’s disease,renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. Many patients take stress-doses that are extra doses of hydrocortisone or cortisone acetate before or during stressful physical or psychological events. However, the effect of such dosing has no…

NCT04374721 — Clinical Study on Circadian Genes Dysregulation in Patients With Glucocorticoid Disorders

This is a multicentric, prospective, intervention study on circadian genes expression in peripheral blood mononuclear cells as biomarkers of circadian rhythm derangement in patients affected by alterations of endogenous glucocorticoids secretion (Cushing’s Syndrome during active phase, treatment and under remission and newly or on established glucocorticoid replacement therapy adrenal insuffici…

NCT04789993 — Additional Autoimmune Diseases With Type 1 Diabetes in Pediatrics at Diabetes Diagnosis and During Follow-up

This study aims to describe the prevalence of additional autoimmune diseases and their specific antibodies at type 1 diabetes (T1D) diagnosis, and their incidence rate during follow-up, for children and adolescents. It also aims to describe the characteristics of the pediatric cohort followed since 2014 for type 1 diabetes by one of France’s centers of reference for paediatric diabetes.

NCT05350020 — The Effects of Two Brands of Hydrocortisone Injected Intramuscularly Into Deltoid and Thigh Muscles

The study will be looking at the cortisol profiles of hypocortisolaemic patients following 100mg injections of two hydrocortisone preparations (Solu-Cortef® & Hydrocortisone 100mg/ml). The investigators plan to use two methods of intramuscular injection to administer the preparations, one using a 1inch orange needle into the deltoid muscle and the other using a 1.25inch blue needle into the th…

NCT05515055 — Does Relative Hypoglycaemia &/or Sleep Disturbance Contribute to the Lethargy Observed in Addison’s Disease

Addison’s disease is a condition that leads to a reduction in production of steroid hormones from the adrenal glands. These hormones, particularly cortisol have many important roles in the body, one of which is increasing blood sugar. These steroids will be replaced with tablets but fails to mimic the normal increase in natural cortisol levels which increase from around 2am in the early morning…

NCT06309498 — Residual Adrenal Function in Addison’s Disease

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