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Adrenocortical Hyperfunction clinical trials

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NCT ID: NCT06246357 Not yet recruiting - Hyperaldosteronism Clinical Trials

Evaluating the Functional Status of the Adrenal Glands With [68Ga]Ga-PentixaFor in Hyperaldosteronism and Hypercortisolism

Start date: April 26, 2024
Phase: Phase 2
Study type: Interventional

Background: The adrenal glands are 2 small organs that sit on top of each kidney. They release hormones; these are chemicals that control how the body works. Tumors on or outside the adrenal glands are called functional if they release hormones; they are called nonfunctional if they do not. Doctors who treat adrenal tumors need to know which type a person has. Researchers want to find better ways to learn whether an adrenal tumor is functional. Objective: To see if a new radioactive tracer ([68Ga]Ga-PentixaFor) can make it easier to identify functional adrenal tumors with positron emission tomography (PET) scans. Eligibility: People aged 18 years and older with 1 or more adrenal tumors. They must have increased levels of the hormones aldosterone or cortisol. They must also be enrolled in at least 1 other related NIH study (protocols 19-DK-0066, 18-CH-0031, or 09-C-0242). Design: Participants will be screened. They may have imaging scans. Their ability to perform normal activities will be reviewed. Participants will have one PET scan with the study tracer. The tracer will be given through a tube attached to a needle inserted into a vein. Participants will receive the tracer 1 hour before the scan. They will lie still on a bed while a machine captures images of the inside of their body. The scan will take 45 to 90 minutes. Participants heart rate, blood pressure, and rate of breathing will be checked before, during, and after the scan. Participants will have a follow-up visit 3 days after their scan. This visit can be by phone, email, or in person.

NCT ID: NCT06153043 Completed - Clinical trials for Classic Congenital Adrenal Hyperplasia

Fertility and Pregnancy in Patients With Classic Congenital Adrenal Hyperplasia

FERTI-HCS
Start date: January 16, 2024
Phase:
Study type: Observational

Classic congenital adrenal hyperplasia (CAH) is a rare genetic endocrine disorder. Its prevalence is around 1/15.000. It results from a deficiency in 21-hydroxylase, an adrenal steroidogenic enzyme involved in the biosynthesis of cortisol and aldosterone. Enzyme deficiency in the steroideogenesis pathway leads to cortisol and aldosterone deficiency of varying severity, and to the accumulation of precursors (17OHP and Progesterone), which are diverted to the production of androgens (Testosterone and D4AD). There are two clinical forms of classical CAH : the salt wasting form and the simple virilizing form, depending on the degree of aldosterone deficiency. The clinical signs are adrenal insufficiency and hyperandrogenism. Hyperandrogenism manifests itself during foetal life, and may be responsible for virilization of the external genitalia of a female foetus, of varying severity. The challenge in managing this condition is to find the right therapeutic balance. Hydrocortisone and fludrocortisone supplementation must be adapted to control adrenal insufficiency, and limit hyperandrogenism. It must be sufficient to avoid episodes of acute adrenal insufficiency, but not excessive to avoid complications secondary to hypercorticism. During childhood, this balance is necessary for growth and pubertal development. However, this balance is difficult to achieve and maintain over time. In adulthood, the fertility of patients is an important issue. This one remains poorly understood. It was only after the introduction of cortisol supplementation in the treatment of CAH in the 1950s that the first pregnancies were described. Since when, due to the rarity of the pathology, the number of pregnancies studied has remained low, and the literature has little hindsight on the subject. This pathology has long been associated with female infertility, due to many factors : biological, mechanical, psychological and sexual, among others. Biological hyperandrogenism may be responsible for chronic dysovulation, and may render the endometrium unsuitable for embryonic implantation. The virilization of the external genitalia and possible complications of pelvic surgery can be an obstacle to sexuality in these patients. They experience sexual difficulties, particularly during penetrative intercourse. The literature also shows that the majority of these patients are single and that their sexual orientation is more likely to be homosexual. Finally, the desire to have children is less prevalent in these patients than in the general population. The first published studies on the fertility of CAH patients showed a lower pregnancy rate than the general population, but did not take into account the patient' desire to become pregnant. In 2009, Casteras et al demonstrated for the first time in a cohort of CAH patients that fecundity is preserved in patients with a desire to become pregnant. It should be noted that the fertility of patients with CAH may evolve in the coming years in France thanks to the new bioethics law voted in 2021, which now allows unmarried patients and patients in homosexual couples to have access to male gamete donation. In addition, very little is known about the course of pregnancies in patients with CAH. Few pregnancies have been studied to date. Hormonal balance during pregnancy if difficult to monitor, given the absence of reliable biological makers during this period. In this context, it is complicated to know the impact of the pathology and its balance on the course of the pregnancy. The latest articles published on the subject of pregnancy complications are contradictory. Some find an increased risk of gestational diabetes. Others find a higher risk of maternal-fetal infection, low weight for gestational age, or congenital malformations than in general population. The increased risk of miscarriage is debated. On the other hand, articles are unanimous on the most frequent mode of delivery in this population : in the vast majority of cases, patients give birth by ceasarian section, due to their history of pelvic surgery. It is in context that we wish through this study to make a point of fertility and pregnancy in patients with classical CAH.

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: NCT05907291 Recruiting - Clinical trials for Congenital Adrenal Hyperplasia

Evaluate the Safety, Efficacy, and Pharmacokinetics of CRN04894 in Participants With Congenital Adrenal Hyperplasia (TouCAHn)

Start date: July 3, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this Phase 2, open-label, sequential dose cohort study is to evaluate the safety, efficacy, and pharmacokinetics (PK) of CRN04894 in participants with classic congenital adrenal hyperplasia (CAH) caused by 21-hydroxylase deficiency.

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.

NCT ID: NCT05766085 Recruiting - Clinical trials for Arterial Hypertension

Cortisol Secretion, Sensitivity and Activity and Hypertension

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

The goal of this observational study is to evaluate, between patients with arterial hypertension and non hypertensive control group, - the prevalence of hidden hypercortisolism - the relationship between organ damage and oxidative stress level, cortisol secretion degree, sensitivity and peripheral activity

NCT ID: NCT05669950 Recruiting - Clinical trials for Congenital Adrenal Hyperplasia

Study of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia

Start date: December 19, 2022
Phase: Phase 1
Study type: Interventional

This study will evaluate the effects of different doses of Lu AG13909 in adult participants with congenital adrenal hyperplasia, also called CAH. CAH is a rare genetic disorder that affects a person's ability to produce certain hormones. The main goals of this study are to learn about the safety and tolerability of Lu AG13909, how Lu AG13909 behaves in the body, and how the body responds to Lu AG13909.

NCT ID: NCT05663320 Recruiting - Clinical trials for Congenital Adrenal Hyperplasia

A Study of a Virtual Education-Based Transition Intervention to Improve Transition Readiness in Adolescent and Young Adults With Congenital Adrenal Hyperplasia

Start date: April 26, 2024
Phase: N/A
Study type: Interventional

Background: Children with congenital adrenal hyperplasia (CAH) can survive well into adulthood with proper treatment. But the change from pediatric to adult care can be challenging. Many people with CAH need extra support as they learn to take control of their own health care needs. Researchers have studied how people respond to different types of patient education. Now researchers want to find out if virtual education, via computer, is a good way to teach people how to manage CAH as they become adults. Objective: To test a virtual method of delivering patient education to adolescents and young adults with CAH. Eligibility: Adolescents and young adults aged 16 to 22 years who have CAH. They must already be enrolled in Natural History Study Protocol 06-CH-0011. Design: Participants may take part in the study remotely; they may also come to the clinic. They will have 3 visits in 1 year. Participants will complete questionnaires. Topics will include what they know about CAH; whether they remember to take their medications on their own; and whether they schedule their own appointments. They will be asked about their quality of life. They will be asked about their physical and emotional health. All participants will be taught how to care for themselves. The participants will be divided into 2 groups. Some will watch an 11-minute video on CAH that focuses on their goals as they become adults. The others will receive standard education. After 6 months, participants will receive CAH education again. After 12 months, participants will repeat the questionnaires from their first visit.

NCT ID: NCT05607706 Completed - Clinical trials for Stress Related Disorder

Effect of Maternal Odor and Kangaroo Care on Serum Cortisol and Comfort Levels in Preterm Infants: a Randomised Trial

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Aims and objectives: Studies on stress are generally aimed at young children and infants. However, in the neonatal period, "especially in preterm babies", this issue was not given enough attention and was almost completely ignored. Background: They are exposed to different stressors. Too much stress will increase their problems in their future lives. Design: This study was planned as a randomized study to determine the effects of Kangaroo Care and mother scent application on toxic stress in preterm infants in the Neonatal Intensive Care Unit environment and to create evidence-based recommendations regarding these applications. Methods: Research data were collected from a total of 92 preterm babies born. Babies were divided into 3 groups, those who never met their mothers, only mother scent group and KC group. The mother's undershirt was used as the maternal odor. Vital signs, blood cortisol levels and Preterm Infant Comfort Scale scores were determined and recorded each group.The data were evaluated by statistical analysis. The CONSORT checklist for reporting qualitative research was used. Results: In the group that never encountered mother and mother odor, Preterm Infant Comfort Scale, blood cortisol level and vital signs showed severe stress. It was found that maternal odor is effective in reducing this stress, but kangaroo care is much more effective in preventing stress. Conclusion: if premature babies are deprived of their mother, the stress may be exposed to reaches toxic levels. It was determined that kangaroo care application during the treatment of these babies is a more effective method in reducing stress than the maternal odor application method. Relevance to clinical practice: The results of this study will contribute to nurses' use of kangaroo care and maternal odor in the care of preterm babies to prevent stress and related complications.Therefore, it will improve the quality of care of preterm babies in the NICU.

NCT ID: NCT05523115 Completed - Anxiety Clinical Trials

An Exploratory Investigation of a Supplement to Promote Cognitive Health Benefits

Start date: June 15, 2022
Phase: N/A
Study type: Interventional

The Smart Supplement has 20 vitamins and minerals that have strong track records of demonstrating positive health effects, both physiologically and cognitively. This twelve-week trial will examine the effectiveness and efficacy of Heights Smart Supplement on both biomarkers and subjective experiences from participants.