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

Tracking Information

First Received Date ^ICMJE

February 28, 2007

Last Updated Date

February 28, 2007

Start Date ^ICMJE

January 2002

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

insulin sensitivity
local protein turnover
whole body protein turnover
glucose metabolism
serum metabolites
serum hormone levels

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Metabolic Effects of Acute Cortisol Withdrawal in Adrenal Failure

Official Title ^ICMJE

Effects of Cortisol on Carbohydrate, Lipid, and Protein Metabolism; Studies of Acute Cortisol Withdrawal in Adrenocortical Failure.

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Addison Syndrome

Intervention ^ICMJE

Drug: hydrocortisone substitution therapy versus withdrawal

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2003

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Female adrenal failure
Age 18-50
Written informed content

Exclusion Criteria:

Diabetes mellitus
Cancer
Thromboembolic events
Pregnancy and lactation
Heart disease

Gender

Female

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00442390

Other Study ID Numbers ^ICMJE

1998/4375

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University of Aarhus

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

University of Aarhus

Verification Date

February 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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