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Adrenal Insufficiency clinical trials

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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: NCT05806723 Completed - Clinical trials for Diabetes Mellitus, Type 2

Effects of High Intensity Statin Therapy on Steroid Hormones and Vitamin D in Type 2 Diabetic Men

Start date: March 1, 2021
Phase: Phase 4
Study type: Interventional

The aim of the study was to assess the effect of high intensity statin therapy on testicular and adrenal steroids and vitamin D levels in type 2 diabetes males.It is a prospective study, conducted between march 2021 and July 2022, including 60 men with type 2 diabetes, aged 40 - 65 years, statin-free, and in whom a treatment with high intensity statin was indicated. The patients had two visits, before and six months after a daily intake of 40 mg of atorvastatin. During each visit, they underwent a clinical examination including the Androgen Deficiency in the Aging Male (ADAM) questionnaire and a fasting blood sample was collected for biological and hormonal measurements.

NCT ID: NCT05806190 Completed - Clinical trials for Diabetes Mellitus, Type 1

Hypoglycaemia (Low Blood Sugar) in Adults With Diabetes and Adrenal Failure

HYPO-DIAD
Start date: April 17, 2023
Phase:
Study type: Observational

The purpose of this study is to measure how often low blood sugars occur in people who live with both adrenal insufficiency (AI) and diabetes and need to take insulin. People who live with AI need to take steroid replacement tablets every day, for life. Two of the most common types of steroid replacement tablets are called prednisolone and hydrocortisone. Low blood sugar (hypoglycemia) is a very common side effect of taking insulin and can often be unpleasant, frightening and dangerous. People who have adrenal failure are also at risk of hypoglycaemia, although this is rare. It is not known whether taking steroids affects how often hypoglycaemia happens. The study has three aims: 1. To measure how often low blood sugars occur at night in people who live with with both adrenal insufficiency (AI) and insulin-treated diabetes 2. To compare how often low blood sugars occur in people taking prednisolone for their AI versus those taking hydrocortisone. 3. To compare the patterns throughout the day for low blood sugars in those taking prednisolone versus those taking hydrocortisone. The study will compare this information with results in people who have AI without diabetes. Participants will be given continuous glucose monitoring systems (Dexcom G6 devices) which are small wearable devices that measure glucose levels throughout the day and night. They will be asked to wear a device for 30 days. Participants will not be asked to make any changes to their usual medications or their diet.

NCT ID: NCT05457296 Completed - Clinical trials for Adrenal Insufficiency

Salivary Cortisol Measurement in Corticotrope Deficiency Substitution With Hydrocortisone.

Start date: January 1, 2021
Phase: Phase 4
Study type: Interventional

Patients with adrenal insufficiency are most often overdosed with hydrocortisone. To date, there is no reliable marker that can reflect the quality of hydrocortisone substitution. Salivary cortisol is a good reflection of free plasmatic cortisol. However, salivary contamination with the oral intake of hydrocortisone has been described. The aims of the study are to: - evaluate the frequency of salivary contamination by hydrocortisone taken in tablet form and determine its risk factors. - evaluate the quality of hydrocortisone substitution in patients with corticotrope deficiency.

NCT ID: NCT05350982 Completed - Clinical trials for Adrenal Insufficiency

Neonatal, Infant and Toddler Salivary Study (NITS Study)

NITS
Start date: June 7, 2021
Phase:
Study type: Observational

Currently, the only way to analyse glucocorticoids for the screening or diagnosis of AI in young children is via plasma obtained by invasive capillary or venous blood sampling. Thus, there is an unmet need for a safe and simple salivary collection technique for use in children under the age of six years. The development of the SalivaBio offers potential for salivary collection, which is safe, easy and less-invasive than current practice. The SaliPac has been developed to offer a more tolerable and pleasant way of sampling saliva using a SalivaBio in very young children which the investigators envisage being used by parents/carers at home to sample and then post to the hospital for GC analysis.

NCT ID: NCT05070091 Completed - COVID-19 Clinical Trials

The Impact of Pituitary-thyroid and Pituitary-adrenal Axes Function on COVID-19 Clinical Course.

ENDO-COVID19
Start date: January 26, 2021
Phase:
Study type: Observational

The main focus of the study is the assessment of hormonal function in the course of COVID-19 infection with special regard for trends predicting clinical events defined as primary endpoints of the study.

NCT ID: NCT04988269 Completed - COVID-19 Clinical Trials

Assessment of Diurnal Salivary Cortisol Production in COVID-19

Start date: April 15, 2021
Phase:
Study type: Observational

In the year of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic several studies have focused on the effect of the COVID-19 on the adrenal cortex, demonstrating conflicting results. Herein, researchers sought to investigate the adrenal response in patients with COVID-19by assessing the diurnal rhythm of salivary cortisol and the adrenal androgen dehydroepiandrosterone (DHEA), as well as the plasma levels of aldosterone and adrenocorticotropic hormone (ACTH) in consecutive patients before the possible therapeutic administration of dexamethasone. To elucidate the potential association between the magnitude of individual immune response and the adrenal cortex response we included serum measurements of interleukin - 6 (IL-6).

NCT ID: NCT04700644 Completed - Clinical trials for Prader-Willi Syndrome

Assessment of CAI in Adults With PWS.

Start date: May 15, 2020
Phase:
Study type: Observational

Introduction: The prevalence and clinical significance of central adrenal insufficiency (CAI) in adult patients with Prader Willi Syndrome (PWS) remains unclear. Aim: To assess the prevalence of CAI in adults with PWS and to analyse the effects of replacement therapy with hydrocortisone (HCT) in patients with suspected CAI. Material and Methods: Twenty one adult patients with PWS were evaluated. Based on peak cortisol at the 30 minute of the high dose short Synacthen test (HDSST), patients were divided into three groups: CAI (central adrenal insufficiency) - peak cortisol <500nmol/L, intermediate (partial AI) - peak cortisol ≥500 nmol/L and <600 nmol/L and AS (adrenal sufficiency) - peak cortisol ≥ 600 nmol/L. In patients with diagnosed CAI HCT replacement treatment was initiated. Body weight, body fat percentage, signs, and symptoms of CAI were evaluated after 6 and 12 months of treatment.

NCT ID: NCT04488432 Completed - Metabolic Syndrome Clinical Trials

Endocrine, Bone And Metabolic Disorders In Adults After Allogeneic Stem-cell Transplant

ENDOCALLOGREFF
Start date: November 27, 2019
Phase:
Study type: Observational

Allogeneic hematopoietic stem cell transplantations (allo-HSCT) is often indicated in malignant hematologic diseases. Conditioning regimens, used to reduce the tumor burden and to prevent transplant rejection, are based on chemotherapy alone or combined with total body irradiation (TBI). Endocrine complications are frequent transplant-related side effects. Investigators have been well described in children studies but less in adulthood. The objective of this study is to assess retrospectively endocrine, bone and metabolic disorders in adult patients, 12 months after allo-HSCT.

NCT ID: NCT04322435 Completed - Clinical trials for Adrenal Insufficiency, Congenital

Prevalence of Hypoglycaemia in Congenital Adrenal Insufficiency

GLYSUR
Start date: July 15, 2020
Phase: N/A
Study type: Interventional

Children with congenital primary and secondary adrenal insufficiency, who are deficient in cortisol, are at risk for hypoglycaemia, irrespective of appropriate hydrocortisone treatment, which can lead to potentially serious neurological complications. Few series are described in pediatrics. The prevalence of hypoglycaemia is probably underestimated because it is often asymptomatic and capillary blood glucose monitoring is not always performed routinely. The objective of the study is to evaluate the prevalence of hypoglycaemia in children with adrenal insufficiency.