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Continuous Subcutaneous Hydrocortisone Infusion In Addison`s Disease and Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT01840189
Recruitment Status : Completed
First Posted : April 25, 2013
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Addison Disease Type 1 Diabetes Other: Cortef Other: Solu-cortef Phase 2

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Continuous Subcutaneous Hydrocortisone Infusion In Addison`s Disease and Type 1 Diabetes
Study Start Date : May 2013
Primary Completion Date : December 2016
Study Completion Date : December 2016


Arms and Interventions

Arm Intervention/treatment
Active Comparator: Cortef
Treatment A is oral hydrocortisone replacement( Cortef 5 mg)with weight-adjusted doses as suggested by Mah et al , will take 2 months
Other: Solu-cortef

Treatment B is continuous subcutaneous hydrocortisone infusion with the initial standard dose of 10mg/m2/24hrs. Body surface area will be calculated according to the nomogram from the formula of Du Bois and Du Bois.

This part of the study will take 2 months.

Active Comparator: Solu-cortef
This is the treatment B by continuous subcutaneous hydrocortisone infusion. Solu-cortef infusion will be given as Solu-Cortef Act-o-Vial 50mg/ml, , produced by Pfizer. Pump designed for subcutaneous insulin infusion can be used for subcutaneous administration.
Other: Cortef
Treatment A is oral hydrocortisone replacement ( Cortef 5 mg) administered according to weight-adjusted doses for 2 months


Outcome Measures

Primary Outcome Measures :
  1. nocturnal hypoglycemic events [ Time Frame: 4 months ]
    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


Secondary Outcome Measures :
  1. o Nocturnal glycemic variability [ Time Frame: 4 months ]
    monitored by continuous glucose monitor system

  2. hormone and metabolic profile [ Time Frame: 4 months ]
    • 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

  3. o Subjective health status [ Time Frame: 4 months ]
    Self administration of questionnaires


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations

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): NCT01840189


Locations
Norway
Haukeland University Hospiatl
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Study Director: Kristian Løvås, MD, PhD Haukeland University Hospital
Principal Investigator: Katerina Simunkova, PhD Haukeland University Hospital
More Information

Additional Information:
Publications:

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01840189     History of Changes
Other Study ID Numbers: 2012/2218
2012/005516-26 ( EudraCT Number )
First Posted: April 25, 2013    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: December 2016

Keywords provided by Haukeland University Hospital:
Addison disease
Type 1 diabetes
treatment

Additional relevant MeSH terms:
Addison Disease
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Adrenal Insufficiency
Adrenal Gland Diseases
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Anti-Inflammatory Agents