[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adrenal-insufficiency\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adrenal-insufficiency":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,47,81,105,154,187,209,235,258,284,312,333],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100268136","evaluation-of-children-with-endocrine-and-metabolic-related-conditions-100268136",false,"NCT02769975","Evaluation of Children With Endocrine and Metabolic-Related Conditions","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Participants with known or suspected endocrine disorder age 3 months-18 years are eligible for this protocol.\n* Relatives ages 3 months-100 years may be enrolled if clinically indicated for the diagnosis of a proband.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Lack of suspected endocrine disorders.\n* Any medical, physical, psychiatric, or social conditions, which, in the opinion of the investigators, would make participation in this protocol not in the best interest of the patient, will exclude participation. Patients who are critically ill, unstable, or with severe organ failure that may affect\u002Flimit the endocrine evaluation and place unsustainable demands on Clinical Center or NICHD resources will be excluded.","ALL","3 Months","100 Years",{"count":19,"type":20},15000,"ESTIMATED","OBSERVATIONAL","Background:\n\nEndocrine glands give off hormones. Researchers want to learn more about the disorders that affect these glands in children. These disorders might be caused by changes in genes. Genes contain DNA, which is the blueprint of how a cell works. Researchers want to identify the genes involved in endocrine and metabolic disorders. This might help develop new ways to diagnose and treat the disorders.\n\nObjective:\n\nTo study the inheritance of endocrine or metabolism disorders.\n\nEligibility:\n\nChildren ages 3month-18 with known or suspected endocrine or metabolism disorders.\n\nFamily members ages 3months-100. They may participate in the DNA part of the study.\n\nDesign:\n\nParticipants will be screened with a review of their medical records. Their parents or guardians will allow the records to be released.\n\nParticipants will have a clinic visit. This may include a physical exam and medical history.\n\nParents or guardians will give their consent for the study. Participants may have tests, surgery, or other procedures to help diagnose or treat their condition. These could include:\n\nBlood, urine, and saliva tests\n\nGrowth hormone test\n\nPituitary and adrenal function tests\n\nPicture of chromosomes\n\nImaging tests. These may include X-ray, ultrasound, scans, or a skeletal survey.\n\nGenetic tests\n\nSleep study\n\nMedical photographs\n\nIf surgery is done, a tissue sample will be taken.\n\nParticipants may have follow-up visits for diagnosis and treatment.\n\nParticipating relatives will have one visit. This will include medical history and blood and saliva tests. The blood and saliva will be used for DNA testing.",[24,25,26,27,28],"Adrenal Insufficiency","Growth Disorder","Endocrine Diseases","Metabolic Disease","Bone Diseases, Metabolic",[30,31,32,25,33],"Endocrinology","Obesity","Pediatric","Pubertal Development","RECRUITING","2026-06-24",{"date":37,"type":38},"2026-06-25","ACTUAL",{"date":40,"type":38},"2016-07-12",{"date":42,"type":20},"2030-12-31",{"name":44,"class":45},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100582301","a-swiss-assessment-of-hypothalamic-pituitary-adrenal-axis-suppression-after-glucocorticoid-therapy-for-leukemia-and-lymphoblastic-lymphoma-in-children-100582301","NCT06861530","A Swiss Assessment of Hypothalamic-pituitary-adrenal Axis Suppression After Glucocorticoid Therapy for Leukemia and Lymphoblastic Lymphoma in Children","A Swiss Prospective Multicenter Longitudinal Assessment of Hypothalamic-pituitary-adrenal Axis Suppression After Glucocorticoid Therapy for Leukemia and Lymphoblastic Lymphoma in Children: An Explorative Study","LeukemiaCort","Inclusion Criteria:\n\n* diagnosed with ALL or LBL\n* treated for at least 21 sequential days with glucocorticoids between the 01.07.2024 and the 30.06.2027 at the Childrens University Hospital of Basel or at the Childrens Hospital of Aarau\n* lnformed consent can be obtained from the patient\\'s legal representatives (and the patient if at least 14 years of age) within week 2 of treatment with glucocorticoids\n\nExclusion Criteria:\n\n\\- Contraindication to the administration of intravenous synthetical ACTH (Synacthen®): extremely rare cases of known or suspected hypersensitivity to Synacthen®.","18 Years",{"count":57,"type":20},40,"Plain Language Summary:\n\nBackground Glucocorticoids are stress hormones produced by the human body to control inflammation and regulate the immune system. Cortisol is the most well-known example of a glucocorticoid. These stress hormones are essential for the bodys healthy functioning.\n\nTo treat certain types of cancer, such as leukemia (blood cancer) in children, glucocorticoids are administered as medications in large quantities. This helps rapidly reduce the number of cancer cells in the body but also leads to the suppression of the body's natural glucocorticoid production, causing a deficiency.\n\nThis deficiency can be particularly dangerous for children with leukemia, as their immune defenses are already weakened by chemotherapy, leading to an increased risk of infections. Moreover, the signs of glucocorticoid deficiency in children with leukemia are often indistinguishable from the side effects of chemotherapy, making the deficiency harder to detect.\n\nObjectives The aim of the study is to understand how frequently and for how long the body's natural glucocorticoid production is impaired in children treated for lymphoblastic leukemia and lymphoblastic lymphoma. Additionally, the goal is to identify which children are at particularly high risk.\n\nBy gaining a better understanding, this study may help to improve the detection and treatment of glucocorticoid deficiency in children with blood cancer.\n\nMethods Regular low-dose ACTH tests will be conducted to assess the bodys natural glucocorticoid production during and after treatment. To avoid placing additional burden on children who are already heavily affected by the disease, these tests will only be performed when there is already a venous access established and the children are in the hospital for treatment reasons.",[24,60,61],"Leukemia, Lymphoblastic, Acute, Pediatric","Lymphoma, Lymphoblastic",[63,64,65,66,67,68,69],"Adrenal insufficiency","leukemia","leukaemia","childhood","pediatric","paediatric","glucocorticoid","2026-05-04",{"date":72,"type":38},"2026-05-08",{"date":74,"type":38},"2024-08-13",{"date":76,"type":20},"2026-12-31",{"name":78,"class":79},"University Children's Hospital Basel","OTHER",2,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":15,"minAge":55,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":46},"100589505","study-on-the-incidence-of-adrenal-insufficiency-after-surgery-in-primary-aldosteronism-patients-concurrent-with-or-without-autonomous-cortisol-secretion-100589505","NCT06955286","Study on the Incidence of Adrenal Insufficiency After Surgery in Primary Aldosteronism Patients Concurrent With or Without Autonomous Cortisol Secretion","* A confirmed diagnosis of primary aldosteronism or autonomous cortisol secretion;\n\n  ② Completion of unilateral adrenal surgery;\n\n  ③ Voluntary participation and obtaining informed consent. (2) Exclusion criteria\n* Patients with typical clinical manifestations of Cushing's syndrome;\n\n  * Patients suspected of having bilateral cortisol over-secretion, such as PBMAH or PPNAD; ③ Patients with severe surgical complications, unstable postoperative condition (not due to cortical insufficiency), and difficulty completing the ACTH stimulation test;\n\n    * History of ACTH allergy;\n\n      * Patients requiring long-term hormone therapy for other diseases (such as autoimmune diseases);\n\n        * Severe liver and kidney dysfunction (ALT ≥ 3 times the upper limit of normal; patients undergoing dialysis or with an estimated glomerular filtration rate \\\u003C 30 ml\u002Fmin\u002Fm2); ⑦ History of contralateral adrenal surgery; ⑧ Patients with poor compliance who are unable to complete the study.","70 Years",{"count":89,"type":20},521,"To evaluate the incidence of adrenal insufficiency after surgery in Primary aldosteronism (PA) patients concurrent with or without autonomous cortisol secretion (ACS). To assess the recovery time of postoperative adrenal insufficiency in patients. And to explore the clinical characteristics and predictive indicators of patients requiring postoperative hormone replacement therapy.",[92,93,24],"Primary Aldosteronism","Autonomous Cortisol Secretion",[92,93,24,95],"ACTH stimulation test","2026-04-29",{"date":98,"type":38},"2026-05-01",{"date":100,"type":38},"2025-01-02",{"date":102,"type":20},"2028-12-31",{"name":104,"class":79},"Qifu Li",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":113,"sex":15,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":153},"100383878","pharmacokinetics-pharmacodynamics-and-safety-profile-of-understudied-drugs-administered-to-children-per-standard-of-care-pops-100383878","NCT04278404","Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)","Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs","POPS or POP02","Inclusion Criteria:\n\n1. Participant is \\\u003C 21 years of age\n2. Parent\u002F Legal Guardian\u002F Adult Participant can understand the consent process and is willing to provide informed consent\u002FHIPAA:\n3. (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment\n\nExclusion Criteria:\n\n1. Participant has a known pregnancy\n\n   Below exclusion criteria apply only to:\n\n   Participants receiving one or more of the study drugs of interest at the time of enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for details on enrollment cohort specifications and additional eligibility criteria)\n2. Has had intermittent dialysis within previous 24 hours\n3. Has had a kidney transplant within previous 30 days\n4. Has had a liver transplant within previous 1 year\n5. Has had a stem cell transplant within previous 1 year\n6. Has had therapeutic hypothermia within previous 24 hours\n7. Has had plasmapheresis within the previous 24 hours\n8. Has a Ventricular Assist Device\n9. Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study",true,"0 Years","20 Years",{"count":117,"type":20},5000,"The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.",[120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,24,138,139,140,141,142,143],"Coronavirus Infection (COVID-19)","Pulmonary Arterial Hypertension","Urinary Tract Infections in Children","Hypertension","Pain","Hyperphosphatemia","Primary Hyperaldosteronism","Edema","Hypokalemia","Heart Failure","Hemophilia","Menorrhagia","Insomnia","Pneumonia","Skin Infection","Arrythmia","Asthma in Children","Bronchopulmonary Dysplasia","Fibrinolysis; Hemorrhage","Attention Deficit Hyperactivity Disorder","Multisystem Inflammatory Syndrome in Children (MIS-C)","Kawasaki Disease","Coagulation Disorder","Down Syndrome","2026-03-31",{"date":146,"type":38},"2026-04-06",{"date":148,"type":38},"2020-03-05",{"date":150,"type":20},"2027-07",{"name":152,"class":79},"Duke University",51,{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":15,"minAge":162,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":165,"phases":166,"briefSummary":168,"conditions":169,"keywords":172,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":186},"100472738","phase-4-effect-of-supplemental-hydrocortisone-during-stress-in-prednisolone-induced-adrenal-insufficiency-100472738","NCT05435781","Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency","RESCUE - Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency; A Multicentre, Randomised, Double Blinded, Placebo-controlled Clinical Trial on Health-related Quality of Life in Patients With Polymyalgia Rheumatica\u002FGiant Cell Arteritis Receiving Ongoing Low-dose Prednisolone Treatment.","RESCUE","Inclusion Criteria:\n\n* Age ≥ 50 years\n* Women must be postmenopausal (FSH is measured at the screening visit)\n* A diagnosis of PMR\u002FGCA, or both conditions combined.\n* Treatment with prednisolone ≥12 weeks\n* Ongoing prednisolone treatment, with current daily prednisolone dose \\> 0 mg and ≤5 mg. The dose must have been ≤5 mg for minimum 2 weeks at the time of the screening visit.\n\nExclusion Criteria:\n\n* Known primary or secondary adrenal insufficiency\n* Known Cushing's Syndrome\n* Known allergy towards study medication ingredients\n* Severe comorbidity: Heart failure (New York Heart Association class IV); Kidney failure with an estimated glomerular filtration rate \\\u003C30 mL\u002Fmin (Chronic kidney disease stage 4-5); Liver disease in the form of cirrhosis; Active cancer; Known severe immune deficiency; A history of psychiatric disease requiring treatment by a psychiatric department (for affective disorders only if within the last year before study entry)\n* Alcohol consumption \\>21 units per week\n* Planned major surgery during the study period at study entry.\n* Use of drugs that interfere with cortisol metabolism\u002Fmeasurements: Systemic oestrogen treatment (discontinued \\\u003C 1 month before inclusion), Treatment with strong CYP3A4 inhibitors or inducers, Use of other glucocorticoid formulations (Inhaled corticosteroids, intraarticular or intramuscular injections, steroid creams European steroid group IV-V used in the genital area. Note: Permitted glucocorticoid formulations: Eye-drops, nasal spray, glucocorticoid creams European steroid group I-III, and European steroid group IV-V used in the non-genital area only.)\n* Inability to provide written informed consent.","50 Years",{"count":164,"type":20},250,"INTERVENTIONAL",[167],"PHASE4","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)\u002Fgiant 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.",[24,170,171],"Polymyalgia Rheumatica","Giant Cell Arteritis",[173,174,175,176],"Glucocorticoid-induced adrenal insufficiency","Prednisolone","Glucocorticoids","Hypothalamic-pituitary-adrenal axis","2026-03-12",{"date":179,"type":38},"2026-03-16",{"date":181,"type":38},"2022-06-07",{"date":183,"type":20},"2028-03-01",{"name":185,"class":79},"Marianne Christina Klose",3,{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":113,"sex":15,"minAge":55,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":165,"phases":196,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":46},"100450756","updated-diagnostic-cortisol-values-for-adrenal-insufficiency-100450756","NCT05149638","Updated Diagnostic Cortisol Values for Adrenal Insufficiency","Re-assessment of Diagnostic Cortisol Values for Adrenal Insufficiency Using a Highly Specific Cortisol Assay","Inclusion Criteria for healthy volunteers:\n\n\\- Male and female outpatients 18 years or older without prior diagnosis of primary or central adrenal insufficiency\n\nInclusion Criteria for patients with known adrenal insufficiency:\n\n\\- Males and females 18 years or older with established diagnosis of primary or central adrenal insufficiency as previously documented in the electronic medical record by a failed CST (peak cortisol level \\\u003C 18 μg\u002FdL) or morning serum cortisol \\\u003C 3 mcg\u002FdL with an appropriate clinical circumstance (e.g., Sheehan's syndrome, pituitary surgery and\u002For irradiation, bilateral adrenalectomy, etc.) that strongly supports a true diagnosis of primary or central adrenal insufficiency, and current use of physiologic, replacement dose glucocorticoids. Inpatients with non-critical illness and outpatients are eligible\n\nInclusion Criteria for patients with suspected adrenal insufficiency:\n\n\\- Males and females 18 years or older with suspected diagnosis of primary or central adrenal insufficiency by any cause based on clinical evaluation by a study team member. Inpatients with non-critical illness and outpatients are eligible\n\nExclusion Criteria for all groups:\n\n* Moderate to severe liver impairment or abnormal albumin or cortisol binding globulin concentrations\n* Renal impairment with estimated Glomerular Filtration Rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73m2 and\u002For diagnosis of nephrotic syndrome\n* Pregnancy or nursing mothers\n* Use of estrogen preparations\n* Uncontrolled major depressive disorder or psychiatric diseases, severe malnutrition, eating disorders, chronic fatigue syndrome (disorders that alter hypothalamic-pituitary-adrenal (HPA) axis function)\n* Use of any medications that induce hepatic cytochrome P-450 enzymes, e.g., barbiturates, phenytoin, rifampin, aminoglutethimide and mitotane\n* Active medical treatment of Cushing's syndrome (status-post surgical treatment is acceptable)\n* Uncontrolled hypo- or hyperthyroidism\n* Use of biotin within the past 72 hours\n* Regular alcohol and\u002For cannabis use\n* History of bilateral adrenalectomy\n* Treatment for validated primary adrenal insufficiency for greater than 6 months\n* Be assessed by the investigators as unsuitable for participation in this study for any reason\n\nAdditional Exclusion Criteria for healthy volunteers only:\n\n* Regular use of any oral glucocorticoid (e.g. hydrocortisone, prednisone, dexamethasone) within 6 weeks of the screening visit\n* Use of oral or nasal steroid (glucocorticoid) inhalers in the past 2 weeks\n* Regular use of any steroid creams, gels, ointments, or lotions\n* Use of steroid (glucocorticoid) injections in the past 6 months (healthy volunteers)\n* Regular use of opioids\n* Regular use of suboxone\n* Regular use of megestrol acetate",{"count":195,"type":20},90,[197],"NA","The purpose of this study is to determine the cortisol levels that most accurately diagnose a patient with adrenal insufficiency, a condition in which cortisol levels are too low for daily living.",[24],"2026-02-18",{"date":202,"type":38},"2026-02-19",{"date":204,"type":38},"2022-02-03",{"date":206,"type":20},"2027-12-01",{"name":208,"class":79},"Montefiore Medical Center",{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":15,"minAge":162,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":165,"phases":219,"briefSummary":220,"conditions":221,"keywords":224,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":186},"100454119","phase-4-hydrocortisone-and-placebo-in-patients-with-symptoms-of-adrenal-insufficiency-after-cessation-of-glucocorticoid-treatment-100454119","NCT05193396","Hydrocortisone and Placebo in Patients With Symptoms of Adrenal Insufficiency After Cessation of Glucocorticoid Treatment","A Multi-centre, Randomised, Double-blinded, Placebo Controlled 16-weeks Study to Compare the Effect of Hydrocortisone and Placebo in Patients With Giant Cell Arteritis (GCA)\u002F Polymyalgia Rheumatica (PMR) With Patient-reported Symptoms of Adrenal Insufficiency After Cessation of Glucocorticoid Treatment.","REPLACE","Inclusion Criteria:\n\n* Age ≥ 50 years\n* A diagnosis of PMR or GCA in GC free remission for \\>2 week and \\\u003C12 weeks after treatment with prednisolone (any dosage) for ≥12 weeks\n\nExclusion Criteria:\n\n* Known primary or secondary adrenal insufficiency\n* Known Cushing´s syndrome\n* Heart failure (New York Heart Association class IV)\n* Kidney failure with an estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\n* Liver cirrhosis\n* Active cancer\n* Known severe immune deficiency\n* A history of psychiatric disease requiring treatment by a psychiatric department (for affective disorders only if within the last year before study entry)\n* Alcohol consumption \\>21 units per week\n* Planned major surgery during the study period at study entry\n* Use of drugs that interfere with cortisol metabolism\u002Fmeasurements:\n* Systemic oestrogen treatment within 1 month before study inclusion\n* Strong CYP3A4 inhibitors or inducers\n* Use of other glucocorticoid formulations: inhaled, intra-articular or intramuscular injections, creams European steroid group IV applied in genital area\n* Permitted glucocorticoid formulations: eye-drops, nasal spray, creams European group I-III, and European group IV applied in non-genital area\n* Inability to provide written informed consent",{"count":218,"type":20},100,[167],"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, new evidence 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, it was 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\u002FGCA 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\u002FGCA disease activity. The scenario has been designated as \"the steroid withdrawal syndrome\". 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.\n\nTherefore, investigators of this study will perform the first placebo-controlled randomised controlled trial (RCT) in patients with PMR and GCA after planned cessation of GC treatment. Investigators argue that neither watchful waiting nor routine hydrocortisone replacement are infallible. The study will be the first evidence-based guidance and aid to GIA patients and thus meet an important need for many thousand patients.",[24,222,223],"Polymyalgia Rheumatica (PMR)","Giant Cell Arteritis (GCA)",[225],"tertiary adrenal insufficiency","2025-12-15",{"date":228,"type":38},"2025-12-22",{"date":230,"type":38},"2022-02-01",{"date":232,"type":20},"2026-01",{"name":234,"class":79},"Marianne Andersen",{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":113,"sex":15,"minAge":55,"maxAge":242,"enrollmentInfo":243,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":46},"100605868","establishment-and-clinical-application-of-reference-intervals-of-salivary-cortisol-100605868","NCT07168122","Establishment and Clinical Application of Reference Intervals of Salivary Cortisol","Study for Reference Intervals and Optimal Cut-offs for Salivary Cortisol","Healthy Volunteers:\n\nInclusion Criteria:\n\n1. Age ≥ 18 and ≤ 60 years old;\n2. Body mass index (BMI) ≥ 18.5 and ≤ 24.9 kg\\*m\\^-2;\n3. No previous history of chronic diseases such as hyperglycemia, hypertension, dyslipidemia, coronary heart disease and stroke;\n4. Normal glucose regulation, defined as: fasting blood-glucose \\\u003C 5.6 mmol\u002FL, 2-hour blood-glucose after glucose load \\\u003C 7.8 mmol\u002FL, and glycated hemoglobin (HbA1c) \\\u003C 5.7%.\n\nExclusion Criteria:\n\n1. Liver or kidney dysfunction, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or direct bilirubin higher than 1.5 times the upper limit of normal, or serum creatinine \\>115 μmol\u002FL;\n2. Pregnancy or lactation women, or people with cancer or mental illness;\n3. Factors affecting cortisol levels, including hypothalamus-pituitary-adrenal axis disease, autoimmune disease (systemic lupus erythematosus, rheumatoid arthritis, etc.), diagnosed mental disease, Alzheimer's disease, alcoholism (alcohol \\> 60 g\u002Fd for male, \\>40 g\u002Fd for women) and corticosteroid therapy in the past 3 months (females with contraceptives or estrogen);\n4. Factors affecting saliva collection, such as serious oral problems (oral ulcers, gingival bleeding);\n5. Night shift workers, who are awake from 11:00 PM to 7:00 AM;\n6. Acute infection (body temperature ≥ 37.3 ℃ or C-reactive protein \\> 50 mg\u002FL).\n\nCases:\n\nInclusion Criteria:\n\n1. Aged 18 to 80 years old;\n2. Patients with suspected Cushing's syndrome or adrenal insufficiency.\n\nExclusion Criteria:\n\n1. Corticosteroid therapy within the last 6 weeks;\n2. Acute infection;\n3. Severe oral conditions;\n4. Severe liver and kidney dysfunction;\n5. Alcoholism, depression, or other psychiatric disorders.","80 Years",{"count":244,"type":20},220,"The goal of this observational study is to establish the normal reference intervals of salivary cortisol and optimal cut-offs for Cushing's sydrome and adrenal insufficiency.",[247,248,24],"Healthy Adult","Cushing Syndrome","2025-09-04",{"date":251,"type":38},"2025-09-11",{"date":253,"type":20},"2025-09-01",{"date":255,"type":20},"2027-12-31",{"name":257,"class":79},"Shanghai 6th People's Hospital",{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":15,"minAge":55,"maxAge":264,"enrollmentInfo":265,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":266,"conditions":267,"keywords":270,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":46},"100549170","a-block-and-replace-therapy-with-osilodrostat-and-concomitant-glucocorticoid-replacement-100549170","NCT06430528","A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement","Inclusion Criteria:\n\n* Endogenous Cushing syndrome, either following surgery or not candidates for surgery\n* Under consideration to receive osilodrostat as part of their clinical care\n* Able to provide informed consent.\n\nExclusion Criteria:\n\n* Treatment with other investigational drugs within 30 days or five half-lives (whichever is longer).\n* A history of hypersensitivity to osilodrostat or therapies of a similar chemical class.","75 Years",{"count":5,"type":20},"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).\n\nThe investigators are also evaluating new biomarker steroids to reflect adequate osilodrostat dosing, the durability and safety, and clinical improvement during treatment.",[268,24,269],"Endogenous Cushing Syndrome","Hypercortisolism",[271,272,273,274],"Osilodrostat","Glucocorticoid","Methylprednisolone","Medrol","2025-08-14",{"date":277,"type":38},"2025-08-20",{"date":279,"type":38},"2024-07-19",{"date":281,"type":20},"2027-08",{"name":283,"class":79},"University of Michigan",{"id":285,"slug":286,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":113,"sex":15,"minAge":55,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":165,"phases":292,"briefSummary":293,"conditions":294,"keywords":295,"overallStatus":302,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":46},"100591463","continuous-steroid-monitoring-in-interstitial-fluid-with-wearable-and-nanoparticle-enhanced-biosensors-for-improved-management-of-adrenal-disorders-100591463","NCT06980753","Continuous Steroid Monitoring in Interstitial Fluid With Wearable and Nanoparticle-enhanced Biosensors for Improved Management of Adrenal Disorders","Inclusion Criteria:\n\n* Individuals (males and females) older than 18 years;\n* Patients with primary adrenal insuffiency (cortisol and aldosterone deficiency);\n* Patients with Cushing Syndrome (cortisol excess)\n* Patients with Primary Aldosteronism (aldosterone excess)\n\nExclusion Criteria:\n\n* Use of estrogen-containing oral contraceptive medication within the past 6 weeks;\n* Pregnancy or lactation;\n* Use of oral, inhaled, parenteral, or topical glucocorticoids within the past 30 days.",{"count":291,"type":20},246,[197],"The goal of this project is to provide novel technology that will pave the way from the present single-point (analogue) endocrinology towards continuous cortisol and aldosterone monitoring with full time resolution. Current endocrine practice relies on occasional and often random determination of hormone level or functional tests that require a clinical setting. These measurements include sample extraction and analysis in a clinical laboratory rendering such tests laborious and expensive. Most importantly, through the individual variations of hormone oscillation and spatiotemporal distribution of hormones, infrequent hormone measurements have limited diagnostic and prognostic value as the dynamic changes are not captured and relevant intra-individual variability occurs. A requirement for this vision are sensing solutions capable to track hormone dynamics over prolonged periods at high patient comfort (e.g., at home), as targeted by this research proposal. This project has the overarching goals of (1) establishing dynamic interstitial aldosterone and cortisol monitoring as reliable diagnostic tool for cortisol and aldosterone excess or deficiency, and (2) develop a wearable molecular sensing device to detect them accurately.",[248,92,24],[296,297,298,299,300,301],"Aldosterone","Cortisol","Biossensor","Interstitial fluid","Adrenal insuficiency","Cushing syndrome","NOT_YET_RECRUITING","2025-05-16",{"date":305,"type":38},"2025-05-20",{"date":307,"type":20},"2025-06-01",{"date":309,"type":20},"2025-12-01",{"name":311,"class":79},"University of Sao Paulo General Hospital",{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":11,"sex":15,"minAge":318,"maxAge":55,"enrollmentInfo":319,"targetDuration":4,"studyType":165,"phases":321,"briefSummary":322,"conditions":323,"keywords":4,"overallStatus":302,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":46},"100549550","phase-4-tolerability-and-acceptance-of-two-oral-hydrocortisone-compounding-formulation-for-pediatrics-100549550","NCT06435481","Tolerability and Acceptance of Two Oral Hydrocortisone Compounding Formulation for Pediatrics","Inclusion Criteria:\n\n* Outpatients of both sexes, ≥ 6 years old without swallowing problems and up to 17 years old, at the time of signing the informed consent document by parent(s) or guardian(s) and\u002For patients.\n* Diagnosis of adrenal hyperplasia or isolated primary adrenal insufficiency or panhypopituitarism (secondary or tertiary adrenal insufficiency).\n\nExclusion Criteria:\n\n* Known hypersensitivity to any of the excipients in the formulation of hydrocortisone.\n* Any disorder or situation (decompensation) that, in the opinion of the investigating physician, poses a risk of non-compliance with the treatment.","6 Years",{"count":320,"type":20},35,[167],"The study aims to evaluate the tolerability and acceptance of two compounded formulations of hydrocortisone prepared in the Vall d'Hebron University Hospital (VHUH) Pharmacy Service: one, an oral suspension and the other, chewable tablets prepared using a volume dosing device (M3DIMAKER 3D printer). The main goal is to enhance patient care and adherence among pediatric patients.\n\nThis prospective, experimental study employs a randomized, crossover design and will take place solely at VHUH. Approximately 25-30 eligible patients diagnosed with adrenal hyperplasia, isolated primary adrenal insufficiency, or panhypopituitarism will be recruited. Each patient will receive each hydrocortisone formulation for a period of 3 months, totaling 6 months of treatment per patient. All patients will receive the medication at their usual dose and both formulations to assess tolerability and acceptance.",[24],"2024-05-24",{"date":326,"type":38},"2024-05-30",{"date":328,"type":20},"2024-09",{"date":330,"type":20},"2026-09",{"name":332,"class":79},"Hospital Universitari Vall d'Hebron Research Institute",{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":339,"eligibilityCriteria":340,"healthyVolunteers":11,"sex":15,"minAge":55,"maxAge":87,"enrollmentInfo":341,"targetDuration":4,"studyType":165,"phases":343,"briefSummary":344,"conditions":345,"keywords":348,"overallStatus":302,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":357,"leadSponsor":359,"locationsCount":46},"100494317","treatment-study-in-patients-treated-with-both-insulin--hydrocortisone-100494317","NCT05716607","Treatment Study in Patients Treated With Both Insulin & Hydrocortisone","Randomized Cross-over Trial in Patients Treated With Both Insulin & Hydrocortisone","INSCORT","Inclusion Criteria:\n\nMen and women at age 18 to 70 years, with BMI 18-32 kg\u002Fm2 and well-defined both insulin-treated diabetes \\& Addison's disease for \\>12 months each, on insulin treatment and stable hydrocortisone replacement with once-daily dual-release hydrocortisone (20-30 mg\u002Fday) for \\>3 months.\n\nExclusion Criteria:\n\n* Any medication with other glucose lowering agents than insulin\n* Any additional underlying or intercurrent disease that may need regular or periodic pharmacological treatment with glucocorticoids during the study period, including infectious diseases\n* Any medication with agents which in the investigator's judgement might interfere with the study drugs kinetics, including therapies affecting gastrointestinal emptying or motility\n* Any medication with oral estrogen supplementation and\u002For regular DHEA medication for the past 4 weeks\n* Clinically significant renal dysfunction with a serum creatinine above 160 mmol\u002FL\n* Active malignancy\n* Clinical or laboratory signs of significant cerebral, cardiovascular, respiratory, hepatobiliary\u002Fpancreatic disease which in the investigator's judgement may interfere with the study assessment\n* Pregnant or lactating women\n* Alcohol\u002Fdrug abuse or any other condition associated with poor patient compliance, including expected non-cooperation, as judged by the investigator.",{"count":342,"type":20},16,[197],"The aim of INS.CORT trial is, by studying glycemic variability in a well-defined patient group with both insulin \\& hydrocortisone (patients with concomitant insulin-treated diabetes \\& Addison's disease) and collecting information about the administration -time point and doses- of insulin, hydrocortisone and food intake with the help of new technology to improve the treatment in all patients treated with both insulin \\& glucocorticoids.",[346,24,347],"Diabetes Mellitus","Polyglandular Autoimmune Syndrome",[349,350,351,352],"Insulin treatment","Hydrocortisone treatment","Opposing effects on glucose metabolism","Randomized Controlled Trial","2024-04-28",{"date":355,"type":38},"2024-04-30",{"date":328,"type":20},{"date":358,"type":20},"2027-12",{"name":360,"class":361},"Vastra Gotaland Region","OTHER_GOV"]