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Adrenal Insufficiency clinical trials

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NCT ID: NCT06435481 Not yet recruiting - Clinical trials for Adrenal Insufficiency

Tolerability and Acceptance of Two Oral Hydrocortisone Compounding Formulation for Pediatrics

Start date: September 2024
Phase: Phase 4
Study type: Interventional

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. This 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.

NCT ID: NCT06430528 Recruiting - Clinical trials for Adrenal Insufficiency

A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement

Start date: May 2024
Phase:
Study type: Observational

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.

NCT ID: NCT06309498 Recruiting - Clinical trials for Adrenal Insufficiency

Residual Adrenal Function in Addison's Disease

ADD-RES
Start date: January 1, 2023
Phase:
Study type: Observational

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

NCT ID: NCT06299020 Not yet recruiting - Clinical trials for Intermittent Fasting

Risks of Intermittent Fasting in Patients With Primary Adrenal Insufficiency

Start date: March 4, 2024
Phase: N/A
Study type: Interventional

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 fourteen days (one week of fasting and one week of non-fasting).

NCT ID: NCT06260462 Completed - Clinical trials for Adrenal Insufficiency

Effects of Steroid Replacement Therapy on Metabolic, Cardiovascular and Bone Outcomes in Adrenal Insufficiency

Start date: January 1, 2012
Phase: Phase 3
Study type: Interventional

The current study is a randomized, open study aimed to compare the effects of conventional glucocorticoid replacement treatment and dual-release hydrocortisone on anthropometric, metabolic, cardiovascular and bone outcomes in treatment-naïve patients with primary adrenal insufficiency and secondary adrenal insufficiency in a 10 year-observation period.

NCT ID: NCT06208098 Not yet recruiting - Clinical trials for Glucocorticoid-induced Adrenal Insufficiency

Post-corticosteroid Insufficiency: Search for a Threshold Value for Cortisol at 8 Hours, Prospective Study

SYNASTOPRO
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

Post-corticosteroid insufficiency is found in 40-60% of patients within 10 weeks following the cessation of prolonged corticosteroid therapy and in 20% of patients still after 1 year. Screening in pediatrics is done by carrying out a dynamic test, often the low-dose Synacthen test, which requires day hospitalization. The investigators established in a single-center retrospective study that plasma cortisol at the start of the test could predict the result of the low-dose Synacthen test in patients treated with chronic corticosteroid therapy using two thresholds. A cortisol < 144 nmol/L makes it possible to predict corticotropic insufficiency with a specificity of 94%, while a plasma cortisol > 317 nmol/L eliminates corticotropic insufficiency with a sensitivity of 95%. These thresholds need to be confirmed by a prospective study, and in a population representative of the diversity of children treated with prolonged corticosteroid therapy. Furthermore, certain studies have demonstrated the benefit of salivary cortisol compared to plasma cortisol. Performing salivary cortisol could facilitate screening in consultation.

NCT ID: NCT06206655 Recruiting - Liver Cirrhosis Clinical Trials

Diagnosis of Adrenal Insufficiency in Liver Cirrhosis Patients

DALI
Start date: December 1, 2023
Phase:
Study type: Observational

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.

NCT ID: NCT06148090 Recruiting - Clinical trials for Adrenal Insufficiency

Screening for Adrenal Insufficiency During Dermocorticoid Reduction in Bullous Pemphigoid (BP)

PB-DEPIST
Start date: January 4, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06008184 Recruiting - Clinical trials for Adrenal Insufficiency

Real-time Monitoring of Cortisol - Comparison of Cortisol Levels in Four Biological Fluids

SensoCort
Start date: September 1, 2021
Phase:
Study type: Observational

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).

NCT ID: NCT05931926 Not yet recruiting - Clinical trials for Adrenal Insufficiency

Feasibility and Validation of the Fluispotter®, a Novel Intravenous System for Serial Blood Sampling

FLUISPOTTER
Start date: November 1, 2023
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to test the Fluispotter® technology: A novel system for collection of serial venous samples, which may overcome some of the problems associated with repeated sampling or 20-hour collection of blood samples using standard procedures. The Fluispotter® is the first fully automated, wearable device for obtaining serial blood samples from humans. It is designed to function without operator intervention. The wearable device and - when in place - painless sampling allow sampling during different situations e.g., during sleep, work, play or exercise - whatever the sampling situation requires, including sampling not possible today using wet samples e.g. during everyday activities. Further, it reduces the number of man-hours needed for serial sampling, and minimizes the risks of sample loss, wrong timing, misidentification and contamination. The primary purpose of this investigator-initiated study is to assess the feasibility, including benefits and harms, of the Fluispotter®, a novel method for serial blood sampling, versus standard blood sampling. The planned setting is a test of the Fluispotter® is a 20-hour period in healthy adults and in adults with secondary adrenal insufficiency due to pituitary disease.