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Adrenal Insufficiency clinical trials

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NCT ID: NCT04273750 Completed - Acute Kidney Injury Clinical Trials

RAI & HRS: Relationship Between Relative Adrenal Insufficiency and Failure of Treatment in Hepatorenal Syndrome

Start date: March 5, 2018
Phase:
Study type: Observational

Hepatorenal syndrome is a life-threatening medical condition and a serious complication of advanced liver scarring (cirrhosis). It consists of a deterioration of the function of the kidneys caused by a severe alteration in the circulation (blood flow to the kidneys) due to liver cirrhosis. Only around half of the patients respond to treatment which consists of intravenous medication. Moreover, the adrenal glands, which are located on the kidneys, also suffer an alteration in the blood flow leading to deterioration in their function as well. Thus, these patients produced less cortisol than needed; this situation is called "relative adrenal insufficiency". Cortisol is an important hormone necessary in extreme situations such as severe diseases. This is a study which will assess the relationship between the presence of adrenal dysfunction and failure to treatment in patients with hepatorenal syndrome.

NCT ID: NCT03709381 Completed - Clinical trials for Adrenal Insufficiency

Effect of Adrenocorticotropic Hormone on Vascular Endothelial Growth Factor Release in Children Study

Start date: October 1, 2017
Phase: Early Phase 1
Study type: Interventional

Bone disease and adrenal suppression are two of the many side effects of steroid use in pediatrics. Evidence has shown that adrenocorticotropic hormone (ACTH) protects against the adverse bone effects of steroids in animals and in vitro models, but this has not yet been evaluated in humans. The proposed mechanism in these studies is that ACTH stimulates osteoblasts in bone to release Vascular Endothelial Growth Factor (VEGF), which increases the vascularity in high risk areas of bone. This can potentially be protective against osteonecrosis and osteopenia, which can lead to bone fractures if not prevented. The VEGF release can also be used to demonstrate that an administration of exogenous ACTH occurred. This could be important in diagnosing adrenal insufficiency (AI). One of the tests to assess central AI is the low-dose ACTH stimulation test (LDAST). This test has a high rate of false positive results due to technical limitations. However, if an ACTH-stimulated VEGF level can be measured during the test as a marker of the test being done properly, it will allow for proper interpretation of the results (and identification of a false positive), which will reduce the number of patients being incorrectly diagnosed with central AI. This study will recruit ten healthy children and adolescents, ages 9-18, to assess the effects of ACTH on VEGF levels. The investigators will measure the response of VEGF and cortisol to an administration of a low dose and high dose of cosyntropin (the synthetic ACTH analog used in this test). The hypothesis of this study is that VEGF and cortisol will both increase after administration of cosyntropin. At this time, no other studies have demonstrated that VEGF is responsive to ACTH in humans. If the hypothesis is correct, the results will have two main implications. VEGF can be used as a marker of ACTH administration during the LDAST to identify false positive tests. Secondly, this will help further research into whether ACTH can be used to protect against bone disease in high-dose steroid-treated patients. Further studies can be done to assess whether this effect will be the same in patients with AI or steroid-induced adrenal suppression.

NCT ID: NCT03575247 Completed - Clinical trials for Cushing; Syndrome or Disease, Glucocorticoid-Induced

The Risk of Adrenal Insufficiency and Cushing Syndrome Associated With Glucocorticoid Therapy in People With Chronic Inflammatory Diseases

Start date: January 1, 1998
Phase:
Study type: Observational

Glucocorticoids are widely used for the treatment of chronic inflammatory diseases. Although glucocorticoids are effective in controlling disease symptoms, continuous use of the drugs can lead to suppression of adrenal hormones or excessive cortisol level in the blood stream. That is, excess blood cortisol level due to glucocorticoid exogenous supply can either inhibit the 'hypothalamus-pituitary-adrenal axis' for adrenal hormones production or result in Cushing symptoms. In the period between 1989 and 2008 in the UK, it was estimated that 0.6%-0.8% of the general adult population were long-term users of oral glucocorticoids. However, there is no data on the risk of adrenal suppression and Cushing syndrome due to chronic use of glucocorticoids in the UK to date. The aim of the study is to investigate the risk of adrenal insufficiency and Cushing syndrome due to long-term use of glucocorticoids in England.

NCT ID: NCT03505775 Completed - Clinical trials for Adrenal Insufficiency

Evaluation of the Muscular and Cutaneous Sodium Storage by 23Na MRI in Patients With Chronic Adrenal Insufficiency

Start date: February 14, 2017
Phase: N/A
Study type: Interventional

This study investigates the sodium content in the calf muscle and the skin obtained via 23Na-magnetic resonance imaging in patients with chronic adrenal insufficiency compared to healthy controls.

NCT ID: NCT03499990 Completed - Clinical trials for Adrenal Insufficiency

Study to Investigate Adrenal Crisis (Six-year Follow-up)

Start date: August 13, 2016
Phase:
Study type: Observational

Patients with adrenal insufficiency are at risk to suffer from life threatening adrenal crisis. The aim of this trial was to reevaluate the frequency of adrenal crisis and risk factors for crisis within a prospective study (six-years follow-up of a former prospective study).

NCT ID: NCT03426332 Completed - Clinical trials for Adrenal Insufficiency

Management of Adrenal Emergency in Germany

MAdEy
Start date: November 2015
Phase: N/A
Study type: Observational

The management of adrenal crisis is often problematic and the time to adequate treatment is frequently delayed.The aim of the study is to evaluate the management of adrenal emergencies requiring parenteral glucocorticoid treatment by a prospective multicenter study in patients with chronic adrenal insufficiency.

NCT ID: NCT03426319 Completed - Clinical trials for Adrenal Insufficiency

Cardiovascular Status in Adrenal Insufficiency

CVCORT-AI
Start date: August 2013
Phase: N/A
Study type: Observational

Within this trial, the cardiovascular status and metabolic profile of patients with chronic primary adrenal insufficiency is evaluated.

NCT ID: NCT03368066 Completed - Cirrhosis Clinical Trials

Is Adrenal Insufficiency Under-diagnosed in Hospitalized Cirrhosis Patients?

Start date: January 29, 2018
Phase: Phase 3
Study type: Interventional

The hepatoadrenal syndrome has been well described in the literature and is known to be associated with poorer outcomes in both stable and critically ill cirrhotic patients. In chronic liver disease, adrenal (and more specifically cortisol) insufficiency is thought to be a byproduct of altered lipid metabolism that results in decreased HDL production and thus decreased delivery of cholesterol to the adrenal for subsequent corticosteroid production. Studies to date have implicated lecithin-cholesterol acetyltransferase (LCAT) as the key enzyme which is deficient in some cirrhotic patients, leading to an impaired ability to esterify cholesterol and thus a loss of normal cellular functioning and membrane stability. The investigators seek to quantify this LCAT deficiency in a cohort of cirrhotic patients and demonstrate its association with various abnormal physiologies associated with chronic liver disease, including spur cell anemia, low HDL levels, and adrenal insufficiency. Hospitalized cirrhotic patients at UVA that meet study eligibility criteria will be approached by a member of the study team to obtain consent for participation. If a patient agrees to become a study subject, they will have an approximate total of 35ml of blood drawn the following morning. Lab tests to be performed include: peripheral blood smear, lipid panel, free cortisol, cortisol binding globulin, serum cholesterol esters (surrogate for LCAT enzyme activity), and a standard-dose cortisol stimulation test. The latter involves blood drawn with the initial collection, administration of an intravenous 250mcg dose of synthetic ACTH, and then repeat small-volume blood draws at 30 minutes and 60 minutes later. Subjects will be classified as adrenally sufficient or insufficient on the basis of as standard-dose cortisol stimulation test. Variables of interest for comparison between the groups include MELD score, Child-Turcotte-Pugh (CTP) classification, high-density lipoprotein (HDL) levels, presence of spur cell anemia, serum cholesterol ester percentage (surrogate for LCAT enzymatic activity), cortisol binding globulin levels, and free cortisol levels. Student's t-test and Chi Square tests will be utilized to determine significance; a p <0.05 value will be used as our threshold for significance. If multiple factors are found to be significantly different in a univariate fashion between classification groups, a multivariate logistic regression analysis will be performed for adjusted analysis. The investigators will also seek to define any correlations between variables. Furthermore, the investigators will assess correlation between MELD score and serum cholesterol ester percentage, spur cell anemia, HDL levels, cortisol binding globulin levels, and free cortisol levels; similar correlate analysis will be done using CTP classification instead of MELD score.

NCT ID: NCT03343327 Completed - Clinical trials for Adrenal Insufficiency

A Study of Chronocort® Versus Cortef ® in Healthy Adult Male Subjects

Start date: February 19, 2018
Phase: Phase 1
Study type: Interventional

This was a single centre, open label, randomised, two period, crossover study to evaluate the bioavailability of Chronocort® versus Cortef® immediate release hydrocortisone tablets in dexamethasone-suppressed healthy adult male subjects.

NCT ID: NCT03311932 Completed - Clinical trials for Adrenal Insufficiency

A Study of Infacort® Versus Cortef® in Healthy Adult Male and Female Subjects

Start date: April 16, 2018
Phase: Phase 1
Study type: Interventional

This was a two-part, single centre, open-label, randomised, single dose, two-period, crossover study to evaluate the bioavailability of Infacort® versus Cortef® immediate release hydrocortisone tablets in dexamethasone-suppressed healthy adult male and female subjects in the fasted and fed states.