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Metabolic Effects of Acute Cortisol Withdrawal in Adrenal Failure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00442390
First Posted: March 1, 2007
Last Update Posted: March 1, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Aarhus
  Purpose
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 Intervention
Addison Syndrome Drug: hydrocortisone substitution therapy versus withdrawal

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • insulin sensitivity
  • local protein turnover
  • whole body protein turnover
  • glucose metabolism
  • serum metabolites
  • serum hormone levels

Estimated Enrollment: 10
Study Start Date: January 2002
Estimated Study Completion Date: January 2003
  Eligibility

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 Submitted: February 28, 2007
First Posted: March 1, 2007
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
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone
Anti-Inflammatory Agents