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Report for Clinical Trial NCT03410160

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Predisposing Factors for the Incidence of Adrenal Crisis in Chronic Adrenal Insufficiency

Within this clinical study patients with chronic adrenal insufficiency will be investigated by clinical and biochemical examination as well as questionnaire to identify predisposing factors for adrenal crisis.

NCT03410160 Adrenal Insufficiency
MeSH:Adrenal Insufficiency
HPO:Adrenal insufficiency

1 Interventions

Name: Clinical and biochemical examination.

Description: Patients with chronic adrenal insufficiency were assessed by clinical and biochemical examination as well as questionnaire to evaluate the quality of hormone replacement therapy with glucocorticoids, education status, cortisol-metabolism, catecholamine deficit, chronic inflammation and variations of the glucocorticoid receptor.
Type: Diagnostic Test
Group Labels: 2

High frequency of adrenal crisis Low frequency of adrenal crisis


Primary Outcomes

Description: Measurement of hsCRP (mg/dl) and Interleukin-6 (pg/ml) levels. Hypothesis: Patients with chronic adrenal insufficiency and a high frequency of adrenal crisis exhibit higher hsCRP and Interleukin-6 levels.

Measure: Chronic inflammation (hsCRP, Interleukin-6)

Time: 1 day

Description: Measurement of cortisol-levels (mg/dl) before as well as 60 min and 120 min after ingestion of hydrocortisone. Hypothesis: Patients with chronic adrenal insufficiency and a high frequency of adrenal crisis exhibit a faster hydrocortisone metabolism.

Measure: Cortisol metabolism

Time: 1 day

Description: Evaluation of hormone replacement therapy with glucocorticoids by a clinical score. Hypothesis: Patients with chronic adrenal insufficiency and a high frequency of adrenal crisis suffer from under-replacement.

Measure: Replacement therapy with glucocorticoids

Time: 1 day

Description: Evaluation of hormone replacement therapy with mineralocorticoids by a clinical and biochemical assessment. Hypothesis: Patients with chronic adrenal insufficiency and a high frequency of adrenal crisis suffer from under-replacement.

Measure: Replacement therapy with mineralocorticoids

Time: 1 day

Description: Evaluation of glucocorticoid-receptor-polymorphisms (ER 22/23 EK, N363S, bcl1, 9beta, Tth3l). Hypothesis: Patients with chronic adrenal insufficiency and a high frequency of adrenal crisis have a higher prevalence of glucocorticoid-receptor-polymorphisms.

Measure: Glucocorticoid-receptor-polymorphisms

Time: 1 day

Description: Evaluation of catecholamine-levels (ng/l). Hypothesis: Patients with chronic adrenal insufficiency and a high frequency of adrenal crisis have a more pronounced catecholamin-deficit.

Measure: Catecholamine-levels

Time: 1 day

Description: Evaluation of patient education by questionnaire. Hypothesis: Patients with chronic adrenal insufficiency and a high frequency of adrenal crisis have a worse education status.

Measure: Patient education

Time: 1 day

Time Perspective: Prospective

Case-Control


There is one SNP

SNPs


1 N363S

Evaluation of glucocorticoid-receptor-polymorphisms (ER 22/23 EK, N363S, bcl1, 9beta, Tth3l). --- N363S ---



HPO Nodes


HPO: