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Metabolic Effects of Acute Cortisol Withdrawal in Adrenal Failure

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ClinicalTrials.gov Identifier: NCT00442390
Recruitment Status : Completed
First Posted : March 1, 2007
Last Update Posted : March 1, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
Effects of adrenal steroids is generelly drawn from studies of hypercortisolism. The effects of physiological cortisol substitution and withdrawal is studied and related to the clinical syndrome of adrenal insufficiency.

Condition or disease Intervention/treatment
Addison Syndrome Drug: hydrocortisone substitution therapy versus withdrawal

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Cortisol on Carbohydrate, Lipid, and Protein Metabolism; Studies of Acute Cortisol Withdrawal in Adrenocortical Failure.
Study Start Date : January 2002
Estimated Study Completion Date : January 2003


Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. insulin sensitivity
  2. local protein turnover
  3. whole body protein turnover
  4. glucose metabolism
  5. serum metabolites
  6. serum hormone levels

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female adrenal failure
  • Age 18-50
  • Written informed content

Exclusion Criteria:

  • Diabetes mellitus
  • Cancer
  • Thromboembolic events
  • Pregnancy and lactation
  • Heart disease
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): NCT00442390


Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Jens Juel Christiansen, PhD University of Aarhus
Study Chair: Claus H Gravholt, MD University of Aarhus
Study Chair: Christian B Djurhuus, PhD University of Aarhus
Study Chair: Per Iversen, PhD University of Aarhus
Study Chair: Jens S Christiansen, Professor University of Aarhus
Study Chair: Ole Schmidt, Professor University of Aarhus
Study Chair: Jørgen Weeke, Professor University of Aarhus
Study Chair: Jens OL Jørgensen, MD University of Aarhus
Study Director: Niels Møller, Professor University of Aarhus
More Information

ClinicalTrials.gov Identifier: NCT00442390     History of Changes
Other Study ID Numbers: 1998/4375
First Posted: March 1, 2007    Key Record Dates
Last Update Posted: March 1, 2007
Last Verified: February 2007

Keywords provided by University of Aarhus:
Cortisol
adrenal insufficiency
glucose metabolism
protein metabolism
lipid metabolism
insulin sensitivity.

Additional relevant MeSH terms:
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Anti-Inflammatory Agents