Text Size

Metabolic Effects of Acute Cortisol Withdrawal in Adrenal Failure

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00442390
First received: February 28, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00442390     History of Changes
Other Study ID Numbers: 1998/4375
Study First Received: February 28, 2007
Last Updated: February 28, 2007
Health Authority: Denmark: Danish Dataprotection Agency

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

Additional relevant MeSH terms:
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
 Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on May 21, 2013