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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-010917-61 | EudraCT Number |
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Addison's disease is a rare condition which in most cases is caused by autoimmune destruction of the adrenals, leading to deficiency of cortisol, aldosterone and adrenal androgens. Unrecognized the disease is life threatening, but with proper treatment patients can live near normal lives.
The conventional glucocorticoid replacement therapy renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. Glucocorticoid replacement therapy is technically feasible by continuous subcutaneous hydrocortisone infusion (CSHI), and can mimic the normal diurnal cortisol rhythm. This study aims to further evaluate CSHI treatment in terms of metabolic effects, effects on health-related quality-of-life and sleep in an 8 months randomised open label clinical trial with crossover design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral hydrocortisone | Active Comparator |
| |
| Continous subcutaneous hydrocortisone infusion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solu-Cortef (hydrocortisone) | Drug | Continuous Subcutaneous Hydrocortisone infusion via insulin pump. Doses adjusted to body surface area. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Morning (08-09) plasma ACTH | Time 0, months 2, 3, 5, 7 and 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Health-Related Quality of Life; evaluated by SF-36 vitality scores and AddiQoL scores | At time 0 and months 2,3,5,7 and 8 | |
| Sleep; evaluated by Pittsburgh Sleep Quality Index (PSQI), and 7-days' Actigraph registration combined with self-reported sleep diary |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristian Løvås, MD,PhD | Haukeland University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Bergen | 5021 | Norway | |||
| Karolinska Institutet |
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| ID | Term |
|---|---|
| D000224 | Addison Disease |
| ID | Term |
|---|---|
| D000309 | Adrenal Insufficiency |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
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| ID | Term |
|---|---|
| C007133 | hydrocortisone hemisuccinate |
| D006854 | Hydrocortisone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| Cortef (hydrocortisone) | Drug | Oral treatment 3 times a day. Weight adjusted doses. |
|
|
| PSQI: 0 and months 2,3,5,7 and 8; Actigraph/sleep diary: months 2 and 7 |
| 24h cortisol profiles in serum and saliva | months 2 and 7 |
| S-glucose, 24 h profile | months 2 and 7 |
| Insulin sensitivity assessed by euglycemic clamp | Months 2 and 7 |
| Stockholm |
| Sweden |
| Uppsala University | Uppsala | Sweden |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |