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Adrenocortical Hyperfunction clinical trials

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NCT ID: NCT04903587 Recruiting - Clinical trials for Congenital Adrenal Hyperplasia

Gonadal Changes In Congenital Adrenal Hyperplasia Patients

Start date: October 1, 2021
Phase:
Study type: Observational

To detect the prevalence of gonadal changes by US among the patients with CAH. - assess the patients' radiological findings in relation to their hormonal profile. - early management and prevention of complications resulting from possible gonadal dysfunction.

NCT ID: NCT04860180 Active, not recruiting - Clinical trials for Adrenal Incidentaloma

Effect of Surgical or Conservative Approach in Patients With Adrenal Incidentalomas

Start date: September 29, 2016
Phase: N/A
Study type: Interventional

Subclinical hypercortisolism (SH) is a status of asymptomatic hypercortisolism, frequently found in patients with adrenal adenomas (estimated prevalence: 0.8-2% after 60 years of age). Although SH may lead to diabetes, hypertension and osteoporosis, the diagnostic SH criteria and those suggesting the need of adrenalectomy are debated. Indeed, beside the cortisol secretion, the individual cortisol sensitivity may play a role in determining the SH consequences. Subjects with possible SH due to adrenal adenoma will be randomized to surgery/conservative follow up. The effects of surgery on the cardiovascular, bone, metabolic complications of SH and on neuropsychological aspects and quality of life (QoL) and the possibility to predict them by using cortisol sensitivity and secretion markers will be studied. The study may clarify how to individuate patients who can benefit from surgery. These results will help reducing the costs of both useless surgical operations and SH consequences.

NCT ID: NCT04840693 Recruiting - Clinical trials for Adult Glucocorticoid Excess

Genomic and Metabolomic Markers Reflecting the Complications of Hypercortisolism (CUSHINGOMICS)

CUSHINGOMICS
Start date: August 1, 2023
Phase: N/A
Study type: Interventional

The excess of glucocorticoid, whether endogenous or exogenous, results in Cushing's syndrome, associating a particular distribution of fats (accumulation in the face and trunk), a decrease in the thickness of the muscles, diabetes, hypertension or osteoporosis. The level of effects obviously depends on the extent of the excess glucocorticoids, and on the duration of this exposure. However, the manifestations of Cushing's syndrome also depend very much on the sensitivity of each individual to glucocorticoids for each of these conditions. Indeed, for the same duration and level of exposure, some will have diabetes only, others only osteoporosis, others hypertension, while still others will have these three complications. Today the investigators are unable to specify individual risks. For example, will someone develop diabetes when exposed to glucocorticoids? Or on the contrary will blood sugar level remain normal? The same question arises for hypertension and osteoporosis. The deficiency of glucocorticoid, called adrenal insufficiency, causes fatigue and discomfort. The intensity of the signs depends on the depth of the insufficiency. Here again, there is a large variability in the sensitivity of each individual to glucocorticoids: when one substitutes for adrenal insufficiency at a given dose, some individuals will feel well, while others will still remain tired. The investigators are unable to specify participant's individual requirement. The aim of this research is to identify factors that determine individual sensitivity to glucocorticoids. For excess glucocorticoids, the investigators are looking for specific molecular markers for each type of glucocorticoid complication: markers for corticosteroid-induced diabetes, corticosteroid-induced hypertension, or corticosteroid-induced osteoporosis. For adrenal insufficiency, they are also looking for substitute good balance markers for adrenal insufficiency. To answer the research question, it is planned to include 400 subjects exposed to glucocorticoid excess (by excess of endogenous glucocorticoids or induced by corticosteroid therapy) and 100 subjects with adrenal insufficiency. It is also planned to include 100 subjects without excess glucocorticoids but presenting either diabetes, hypertension or osteoporosis; these subjects will constitute a control group. The investigators will perform a very large number of measurements in small amounts of blood and urine, in order to identify a few marks specifically associated with each of the complications. This research will identify, for every person exposed to glucocorticoids, the probability of developping some complications, and reversely the probability of being exempt from other complications.

NCT ID: NCT04833192 Recruiting - Clinical trials for Adrenal Incidentaloma

Evaluation of New Diagnostic Indicator of Subclinical Hypercortisolism

Start date: April 1, 2020
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to evaluate the serum dehydroepiandrosterone sulfate in subclinical hypercortisolism

NCT ID: NCT04806451 Active, not recruiting - Clinical trials for Congenital Adrenal Hyperplasia

Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)

Start date: June 25, 2021
Phase: Phase 3
Study type: Interventional

This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 28 weeks in approximately 81 pediatric participants with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. The study consists of a 28-week double blind, placebo-controlled period, followed by 24 weeks of open-label treatment with crinecerfont. Subsequently, participants may elect to participate in the open-label extension (OLE) period. The duration of participation in the study is approximately 14 months for the core study and will be a variable amount of time per participant for the OLE (estimated to be approximately 3 years).

NCT ID: NCT04783181 Recruiting - Clinical trials for Congenital Adrenal Hyperplasia

A Study of Gene Therapy for Classic Congenital Adrenal Hyperplasia (CAH)

Start date: July 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study is designed to evaluate the safety, tolerability, and efficacy of AAV5 based BBP-631 in adult participants diagnosed with classic congenital adrenal hyperplasia.

NCT ID: NCT04544410 Active, not recruiting - Clinical trials for Congenital Adrenal Hyperplasia

A Ph2b to Evaluate Tildacerfont in the Reduction of Glucocorticoid Steroid Doses in Adult CAH

Start date: September 29, 2020
Phase: Phase 2
Study type: Interventional

An investigation of the ability of Tildacerfont to reduce supraphysiologic glucocorticoid dosing in classic CAH subjects up to 76 weeks of treatment. Optional open label extension up to 240 weeks.

NCT ID: NCT04490915 Active, not recruiting - Clinical trials for Congenital Adrenal Hyperplasia

Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia

CAHtalyst
Start date: November 16, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 24 weeks in approximately 165 adult participants with classic CAH due to 21-hydroxylase deficiency. The study consists of a 6-month randomized, double-blind, placebo-controlled period, followed by 1 year of open-label treatment with crinecerfont. Subsequently, participants may elect to participate in the open-label extension (OLE) period. The duration of participation in the study is approximately 20 months for the core study and will be a variable amount of time per subject for the OLE (estimated to be approximately 3 years).

NCT ID: NCT04457336 Terminated - Clinical trials for Congenital Adrenal Hyperplasia

A Ph2b to Evaluate Clinical Efficacy and Safety of Tildacerfont in Adult CAH

Start date: August 26, 2020
Phase: Phase 2
Study type: Interventional

An investigation of the efficacy and safety of up to 70 weeks of treatment with Tildacerfont in subjects with classic CAH who have elevated biomarkers at baseline on their current GC regimen. Optional open label treatment extension period up to 240 weeks with 200mg Tildacerfont QD.

NCT ID: NCT04433819 Not yet recruiting - Cushing Syndrome Clinical Trials

Nailfold Capillaroscopy Evaluation in Cushing Syndrome Patients

Start date: June 15, 2020
Phase:
Study type: Observational [Patient Registry]

This cross-sectional, single-center study will assess the microvascular function using a nailfold video-capillaroscopy in patients with endogenous Cushing syndrome.