Type 1 Diabetes Clinical Trial
Official title:
Continuous Subcutaneous Hydrocortisone Infusion In Addison's Disease and Type 1 Diabetes
Verified date | December 2016 |
Source | Haukeland University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The conventional glucocorticoid replacement therapy in primary adrenal insufficiency (Addison's disease) renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. The majority of Addison's patients have other organ-specific autoimmune disease, which poses challenges to the replacement therapy. Of particular interest is the combination of Addison's disease and type 1 diabetes, since cortisol affects glucose homeostasis. The clinical experience is that this subgroup of patients is difficult to treat, but very little research has been done to understand and improve their situation. Glucocorticoid replacement is technically feasible by continuous subcutaneous hydrocortisone infusion, and can mimic the normal diurnal cortisol rhythm. This pilot study aims to further evaluate continuous subcutaneous hydrocortisone infusion treatment in terms of metabolic effects especially glycemic control in patients with the combination of Addison's disease and type 1 diabetes in an 5 months cross-over design open clinical pilot study.
Status | Terminated |
Enrollment | 4 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - primary Addison's disease in combination with long-standing Type 1 diabetes Exclusion Criteria: - cardiovascular disease - active malignant disease - pregnant women - pharmacological treatment with glucocorticoids or drugs that interfere with cortisol metabolism (antiepileptics, rifampicin, St. Johns war, estrogens) |
Country | Name | City | State |
---|---|---|---|
Norway | Haukeland University Hospiatl | Bergen |
Lead Sponsor | Collaborator |
---|---|
Haukeland University Hospital |
Norway,
Barker JM. Compounding risk for hypoglycemia: type 1 diabetes and Addison's disease. Diabetes Technol Ther. 2012 May;14(5):383-5. doi: 10.1089/dia.2012.0043. Epub 2012 Apr 16. No abstract available. — View Citation
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Bryan SM, Honour JW, Hindmarsh PC. Management of altered hydrocortisone pharmacokinetics in a boy with congenital adrenal hyperplasia using a continuous subcutaneous hydrocortisone infusion. J Clin Endocrinol Metab. 2009 Sep;94(9):3477-80. doi: 10.1210/jc.2009-0630. Epub 2009 Jun 30. — View Citation
Elbelt U, Hahner S, Allolio B. Altered insulin requirement in patients with type 1 diabetes and primary adrenal insufficiency receiving standard glucocorticoid replacement therapy. Eur J Endocrinol. 2009 Jun;160(6):919-24. doi: 10.1530/EJE-08-1003. Epub 2009 Mar 9. — View Citation
Johannsson G, Nilsson AG, Bergthorsdottir R, Burman P, Dahlqvist P, Ekman B, Engstrom BE, Olsson T, Ragnarsson O, Ryberg M, Wahlberg J, Biller BM, Monson JP, Stewart PM, Lennernas H, Skrtic S. Improved cortisol exposure-time profile and outcome in patients with adrenal insufficiency: a prospective randomized trial of a novel hydrocortisone dual-release formulation. J Clin Endocrinol Metab. 2012 Feb;97(2):473-81. doi: 10.1210/jc.2011-1926. Epub 2011 Nov 23. — View Citation
Lovas K, Husebye ES. Continuous subcutaneous hydrocortisone infusion in Addison's disease. Eur J Endocrinol. 2007 Jul;157(1):109-12. doi: 10.1530/EJE-07-0052. Erratum In: Eur J Endocrinol. 2008 Jun;158(6):939. Dosage error in article text. — View Citation
Mah PM, Jenkins RC, Rostami-Hodjegan A, Newell-Price J, Doane A, Ibbotson V, Tucker GT, Ross RJ. Weight-related dosing, timing and monitoring hydrocortisone replacement therapy in patients with adrenal insufficiency. Clin Endocrinol (Oxf). 2004 Sep;61(3):367-75. doi: 10.1111/j.1365-2265.2004.02106.x. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | nocturnal hypoglycemic events | severe hypoglycemia (needs for another person's assistance, blood glucose = 3.1 mmol / L or prompt recovery after oral carbohydrate, i.v glucose or glucagon administration) and insulin requirement | 4 months | |
Secondary | o Nocturnal glycemic variability | monitored by continuous glucose monitor system | 4 months | |
Secondary | hormone and metabolic profile | Hormone levels : insulin like growth factor 1, growth hormone
Steroid metabolism: adrenocorticotropic hormone , cortisol Metabolic profile: fructosamine, HBA1C, lipid levels, C reactive protein , homeostasis model assessment index |
4 months | |
Secondary | o Subjective health status | Self administration of questionnaires | 4 months |
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