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Cushing Syndrome clinical trials

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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: NCT06324084 Recruiting - Osteoporosis Clinical Trials

PATHophysiology of OSteoporosis: Role of Hidden Cortisol Excess and Its Predictors in Bone Fragility

PATHOS
Start date: April 24, 2023
Phase:
Study type: Observational

Osteoporosis is a chronic skeletal disease which leads to a decrease in bone strength which increases the risk of fractures. Clinically overt hypercortisolism leads to hypertension, central obesity, diabetes and osteoporosis. More recently, even the condition of mild and asymptomatic hypercortisolism has been associated with increased prevalence of chronic complications of cortisol excess and mortality. In patients with osteoporosis this form of hypercortisolism may remain occult (hidden hypercortisolism, HidHyCo). Although asymptomatic, however, this subtle cortisol excess is associated with an increased risk of osteoporosis and fragility fractures. Moreover, HidHyCo prevalence seems to be increased in osteoporotic patients. The HidHyCo case finding is of utmost importance. However, given the high prevalence of bone fragility and the relatively low diagnostic accuracy of the currently available tests for the HidHyCo detection, a mass screening for HidHyCo is considered unthinkable. As now, no guidelines are available for addressing the HidHyCo screening in osteoporosis. Therefore, the aims of the present study are the following: i) to assess the HidHyCo prevalence in a sample of osteoporotic patients; ii) to compare the clinical characteristics between osteoporotic/osteopenic patients with HidHyCo and those without HidHyCo in order to determine the clinical characteristics more frequently associated with the HidHyCo presence and to identify those osteoporotic patients worthy of HidHyCo screening; iii) to further investigate bone quality and turnover in HidHyCo patients, to characterize HidHyco patients from a molecular and genetic point of view and to evaluate the pathogenetic mechanisms explaining the negative effects of endogenous cortisol excess on bone health in these patients and the potential role of the genetic background and of the gut microbiome. The HidHyCo could be present in a not negligible percentage of osteopenic/osteoporotic patients. In these patients, osteoporosis and, if present, other comorbidities can improve by the surgical resection of the adrenal or pituitary adenoma if feasible, or by the use of drugs able to modulate cortisol secretion or glucocorticoid sensitivity. Moreover, the case-finding could be reserved in those patients at higher risk of having HidHyCo, therefore, reducing the costs of a scarcely specific mass screening.

NCT ID: NCT06250699 Recruiting - Clinical trials for Primary Aldosteronism

A Single Center Randomized Controlled Study on the Promotion of Rapid Recovery

Start date: January 3, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to exploring the role of tubeless after adrenalectomy surgery. The main questions it aims to answer are: 1. The safety of tubeless laparoscopic adrenalectomy; 2. The role of tubeless therapy in rapid recovery after adrenalectomy surgery Participants will be randomly divided into two groups: the non drainage group and the drainage group after laparoscopic adrenal surgery, and their pain, first time out of bed, and intestinal recovery time will be observed.

NCT ID: NCT06229405 Recruiting - Pheochromocytoma Clinical Trials

Development of Clinical Evidence for Optimal Management of Adrenal Diseases Based on Real-World Data

Start date: May 10, 2022
Phase:
Study type: Observational [Patient Registry]

This research aims to establish clinical evidence for optimal treatment guidelines for adrenal diseases using real-world data. The approach involves building prospective and retrospective patient registries, which will be utilized to develop and conduct research on disease-specific protocols for adrenal disorders. The study targets patients with primary aldosteronism, pheochromocytoma, adrenal cancer, adrenal incidentalomas, and mild autonomous cortisol secretion. Registries for patients with adrenal diseases will be obtained from Seoul National University Hospital and Asan Medical Center, along with securing a common data model. The ultimate goal is to conduct research to generate clinical evidence for adrenal diseases using these resources.

NCT ID: NCT06050057 Recruiting - Pheochromocytoma Clinical Trials

Surgical Treatment of Adrenal Diseases- Laparoscopic vs. Robotic-assisted Adrenalectomy

Start date: September 3, 2023
Phase:
Study type: Observational

The goal of this multicenter, observational, analytic, randomized clinical trial is to analyze the laparoscopic and robot-assisted method in the surgical treatment of patients with adrenal diseases. The main question it aims to answer are: 1. to find the superiority of one the the surgical method mentioned above 2. to compare the quality of life in patients with adrenal mass before surgery and after laparoscopic or robotic-assisted adrenalectomy.

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: NCT05911620 Recruiting - Metabolic Syndrome Clinical Trials

Evaluation of the Severity of Hepatic Fibrosis by Magnetic Resonance Elastography in the Diagnosis of Endogenous Hypercorticism

HEPACORT
Start date: October 24, 2023
Phase: N/A
Study type: Interventional

The main hypothesis of the HEPACORT study is that upon diagnosis of endogenous Cushing's syndrome, significant liver fibrosis may be present, particularly in the most severe forms of Cushing's syndrome. the HEPACORT study is the first exploratory study to assess the severity of liver fibrosis in patients with Cushing's syndrome or suspected of presenting by Magnetic Resonance Elastography (MRE).

NCT ID: NCT05881005 Recruiting - Cushing Syndrome Clinical Trials

NAC- NAFLD And Cushing

NAC
Start date: September 28, 2023
Phase: N/A
Study type: Interventional

Cushing's Syndrome is a rare disease resulting from prolonged exposure to high levels of circulating cortisol. Clinical manifestations are variable but many patients present a metabolic syndrome (abdominal obesity, insulin resistance, dyslipidemia, hypertension). With regard to the liver, experimental data have shown that excess cortisol leads in an increase in lipogenesis and a reduction in the oxidation of fatty acids. This, in association with an accumulation of visceral adipose tissue and deregulation of adipokines, may contribute to the development of hepatic steatosis in animals. However, few data is available in humans with only one study of 50 patients with Cushing's syndrome estimating the prevalence of hepatic steatosis at 20%. NAFLD (Non-Alcoholic Fatty Liver Disease), is defined as the presence of hepatic steatosis in the absence of secondary causes of intrahepatic fat accumulation. It is a heterogeneous disease ranging from simple liver steatosis, whose prognosis is generally considered to be benign, to inflammation (NASH, Non-Alcoholic Steato-Hepatitis) which may progress to fibrosis, cirrhosis and an increased risk of hepatocellular carcinoma. The prognosis for NAFLD is mainly related to the severity of hepatic fibrosis. In Cushing's syndrome, normalization of cortisol production is the most effective strategy to improve co-morbidities associated with hypercortisolism. However, some of these complications, especially the metabolic co morbidities, could not be completely reversible and no data is available about resolution of hepatic steatosis.

NCT ID: NCT05804669 Recruiting - Cushing Syndrome Clinical Trials

A Study to Evaluate the Safety and PK of CRN04894 for the Treatment of Cushing's Syndrome

Start date: October 12, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase 1b/2a, first-in-disease, open-label, multiple-ascending dose exploratory study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamic biomarker responses associated with CRN04894 (an adrenocorticotropic hormone [ACTH] receptor antagonist) in participants with ACTH-dependent Cushing's syndrome (Cushing's disease or Ectopic ACTH Syndrome [EAS])

NCT ID: NCT05772169 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Study to Determine the Prevalence of Hypercortisolism in Patients With Type 2 Diabetes and Treatment With Korlym® (Mifepristone) (CATALYST)

Start date: March 31, 2023
Phase: Phase 4
Study type: Interventional

This is a Phase 4 study with 2 parts: Part 1 (Prevalence Phase) is non-interventional and will assess the prevalence of hypercortisolism in a population with difficult to control type 2 diabetes (T2D) (hemoglobin A1c ≥7.5%) despite receiving standard-of-care therapies. Part 2 (Treatment Phase) is a randomized, prospective, placebo-controlled, double-blind multi-center trial that will assess the safety and efficacy of mifepristone treatment in patients with hypercortisolism who have difficult to control T2D despite receiving standard of care therapies.