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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: 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: 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: 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.

NCT ID: NCT05716607 Not yet recruiting - Diabetes Mellitus Clinical Trials

Treatment Study in Patients Treated With Both Insulin & Hydrocortisone

INSCORT
Start date: September 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT01703013 Not yet recruiting - Clinical trials for Adrenal Insufficiency

The Significance of Defensin Alpha 4 in the Pathophysiology of the Adrenal Insufficiency in Inflammatory Lung Diseases

Start date: January 2013
Phase: N/A
Study type: Observational

The pathophysiology of the adrenal insufficiency of patients with critical diseases remains unclear. In a prior exploratory study investigating patients with exacerbation of chronic obstructive pulmonary disease (COPD), the investigators demonstrated a highly significant correlation between the expression level of Defensin-alpha 4 (DEFA4) mRNA in blood and the adrenal function assessed via low-dose ACTH tests. The aim of this prospective study is to demonstrate that DEFA4 measured both at the mRNA level (RT-PCR) and at the protein level (Western blot/Elisa) is a reliable biomarker for the prediction of adrenal insufficiency in inflammatory lung diseases (patients with COPD and pneumonia).

NCT ID: NCT00657306 Not yet recruiting - Clinical trials for Cirrhosis With Ascites

Adrenal Insufficiency in Cirrhotics With Ascites. Effects of Hydrocortisone on Renal and Haemodynamic Function

AILD
Start date: May 2008
Phase: Phase 2
Study type: Interventional

Relative adrenal insufficiency (RAI) is an well known condition in patients with septic shock. Liver failure (including chronic liver failure)and sepsis are both characterized by hyperdynamic circulatory failure (with low arterial pressure) and high levels of pro-inflammatory cytokines. Hydrocortisone has been shown to have a beneficial effect on clinical outcome. The aim of this study is to evaluate the incidence of RAI in the different settings of ascites in cirrhosis and the usefulness of hydrocortisone in this context.