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Trial record 29 of 107 for:    "21-hydroxylase deficiency"

Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal Hyperplasia

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ClinicalTrials.gov Identifier: NCT02096510
Recruitment Status : Unknown
Verified December 2016 by Haukeland University Hospital.
Recruitment status was:  Recruiting
First Posted : March 26, 2014
Last Update Posted : December 21, 2016
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital

Brief Summary:
The aim of this study is to compare the effects of tablet treatment, circadian and combined circadian and ultradian subcutaneous hydrocortisone infusion on steroid metabolism and tissue responses to therapy.

Condition or disease Intervention/treatment Phase
Addison Disease Adrenal Hyperplasia Congenital Drug: Solu-Cortef Drug: Cortef Phase 1 Phase 2

Detailed Description:

The conventional glucocorticoid replacement therapy in primary adrenal insufficiency (Addison's disease) and congenital adrenal hyperplasia renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. This therapeutical approach does not enable to restore physiological circadian and ultradian rhythm of glucocorticoids. Current studies conclude that constant or unphysiological administration of glucocorticoids leads to abnormal gene transcription and causes sides effect of glucocorticoids treatment and long standing complications Glucocorticoid replacement is technically feasible by continuous subcutaneous hydrocortisone infusion, which can mimic not only the normal diurnal cortisol rhythm, but potentially also the ultradian cadence.

This is a pilot trial with an open cross-over design of 3 x minimum 2 weeks in 10 patients comparing the effects of tablet treatment versus continuous subcutaneous hydrocortisone infusion versus ultradian subcutaneous hydrocortisone infusion on serum, salivary, tissue hormonal response and glucocorticoid related gene expression.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal Hyperplasia
Study Start Date : August 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
Experimental: continuous subcutaneous hydrocortisone
continuous subcutaneous hydrocortisone infusion (CSHI), Solu-Cortef ® 50mg/ml infusate
Drug: Solu-Cortef
administration by pump for minimum 2 weeks
Other Name: hydrocortisone

Drug: Cortef
tablet treatment 2 ro 3 times per day for 14 days
Other Name: hydrocortisone tablets

Active Comparator: cortef tablets
the patient regular treatment by Cortef 5 mg, produced by Nycomed Pharma two times or three times a day.
Drug: Solu-Cortef
administration by pump for minimum 2 weeks
Other Name: hydrocortisone

Drug: Cortef
tablet treatment 2 ro 3 times per day for 14 days
Other Name: hydrocortisone tablets

Experimental: ultradian subcutaneous hydrocortisone
ultradian subcutaneous hydrocortisone infusion, Solu-Cortef ® 50mg/ml infusate
Drug: Solu-Cortef
administration by pump for minimum 2 weeks
Other Name: hydrocortisone

Drug: Cortef
tablet treatment 2 ro 3 times per day for 14 days
Other Name: hydrocortisone tablets




Primary Outcome Measures :
  1. Serum cortisol -24 hours curve [ Time Frame: 24 hours ]
    admission to hospital for 24 hours


Secondary Outcome Measures :
  1. Salivary cortisol - 24 hours curve [ Time Frame: 24 hours ]
    admission to the hospital for 25 hours

  2. 24 h urine cortisol and metabolites [ Time Frame: 24 hours ]
    urine samples for 24 hours

  3. levels of corticotropic hormone [ Time Frame: 24 hours ]
    blood samples

  4. 24 hours curve of tissue cortisol [ Time Frame: 24 hours ]
    The tissue effect of glucocorticoid replacement - 24 hours curve of tissue cortisol (microdialysis)

  5. gene expression [ Time Frame: 24 hours ]
    m RNA expression of genes



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. clinical diagnosis of primary adrenal insufficiency
  2. Written informed consent

Exclusion Criteria:.

  1. Diabetes mellitus
  2. Severe cardiovascular disease
  3. Active malignant disease
  4. Pregnancy or breast feeding
  5. treatment with interfering drugs
  6. Intake of grapefruit juice

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02096510


Contacts
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Contact: Kristian Løvås, MD, PhD 55973075 kristian.lovas@helse-bergen.no
Contact: Katerina Simunkova, MD, PhD 41079948 katerina.simunkova@k2.uib.no

Locations
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Norway
University Hospital Helse Bergen Recruiting
Bergen, Norway, 5021
Contact: Katerina Simunkova, MD, PhD    41079948    katerina.simunkova@k2.uib.no   
Contact: Kristian Løvås, MD, PhD    55973075    kristian.lovas@helse-bergen.no   
Sub-Investigator: Kristian Løvås, MD, PhD         
Principal Investigator: Katerina Simunkova, MD, PhD         
Sponsors and Collaborators
Haukeland University Hospital
Investigators
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Principal Investigator: Katerina Simunkova, MD, PhD Universtity of Bergen
Study Director: Kristian Løvås, MD, PhD Helse Bergen

Publications:
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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT02096510     History of Changes
Other Study ID Numbers: 2013/1738
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: December 21, 2016
Last Verified: December 2016
Keywords provided by Haukeland University Hospital:
Addison Disease
Adrenal Hyperplasia Congenital
Additional relevant MeSH terms:
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Adrenal Hyperplasia, Congenital
Adrenogenital Syndrome
Adrenocortical Hyperfunction
Addison Disease
Hyperplasia
Pathologic Processes
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn
Steroid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Metabolic Diseases
Adrenal Gland Diseases
Endocrine System Diseases
Gonadal Disorders
Adrenal Insufficiency
Autoimmune Diseases
Immune System Diseases
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Epinephrine
Racepinephrine
Epinephryl borate
Anti-Inflammatory Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents