An observational study in Cushing Syndrome and Hypercortisolism, sponsored by Marmara University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-16.
Sponsored by Marmara University · Observational
This cross-sectional, single-center study will assess the microvascular function using a nailfold video-capillaroscopy in patients with endogenous Cushing syndrome.
Endogenous Cushing's syndrome (CS) is associated with increased macrovascular diseases and impaired endothelial function. There is no clear data about the effects of hypercortisolism on microcirculation.
The primary aim of this study is to evaluate the peripheric microvascular area in patients with Cushing's syndrome. The association of microvascular changes with present comorbidities (diabetes, hypertension, etc.) and disease activation will be evaluated.
Method:
Cushing syndrome patients admitted to our clinic will be included in this study for the next six months after given informed consent.
The following clinical laboratory parameters will be evaluated as cross-sectionally.
Previous medical history, available laboratory parameters (fasting plasma glucose, HbA1c, total cholesterol, triglyceride, HDL, LDL, creatine, AST, ALT, complete blood count, ACTH, dexamethasone suppression tests (1 mg- 2mg), urine free cortisol, FSH, LH, total testosterone, estradiol, IGF-1, TSH, free T3, free T4, prolactin), radiologic images (Cranial MRI and Adrenal MRI) will be recorded from medical charts.
Nailfold microcirculation will be evaluated with video-capillaroscopy: it is a non-invasive atraumatic assessment of the morphology and some functional aspects of cutaneous capillaries.
123 studies on the registry are indexed under Cushing Syndrome; 42 are open to participants now.
This study's planned enrollment of 200 is above the median of 121 across 63 observational studies indexed under Cushing Syndrome.
Browse Cushing Syndrome studies →Marmara University is the lead sponsor of 599 studies on the registry; 138 are open to participants now.
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Patients with diagnosed as endogenous Cushing syndrome, and age and sex matched controls
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Male and female patients diagnosed as Cushing syndrome caused by ACTH-producing pituitary adenoma or cortisol producing adrenal adenoma
Healthy controls matched for age, gender, and body mass index
Nailfold capillary number of tortuous loops
Nailfold capillary area changes
Time frame: 6 months
Nailfold capillary area number of meandering capillaries
Nailfold capillary area changes
Time frame: 6 months
Nailfold capillary avascular areas
Nailfold capillary area changes
Time frame: 6 months
Correlation between nailfold capillary number of tortuous loops and presence of diabetes
Independent risk factors that affected nailfold capillaroscopy images
Time frame: 6 months
Correlation between nailfold capillary number of tortuous loop with urine free cortisol levels
Presence and severity of hypercortisolism as an independent risk factor
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2020; primary completion for Dec 2020, 6 months later.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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