Metabolic Effects of Acute Cortisol Withdrawal in Adrenal Failure - Full Text View

Sponsored by:	University of Aarhus
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00442390

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

Drug Information available for: Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC Insulin Dextrose Epinephrine Epinephrine bitartrate Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment, Bio-equivalence Study
Official Title:	Effects of Cortisol on Carbohydrate, Lipid, and Protein Metabolism; Studies of Acute Cortisol Withdrawal in Adrenocortical Failure.

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

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

Keywords provided by University of Aarhus:

Cortisol
adrenal insufficiency
glucose metabolism

protein metabolism
lipid metabolism
insulin sensitivity.

Study placed in the following topic categories:

Adrenal Insufficiency
Hydrocortisone
Cortisol succinate
Hydrocortisone acetate

Epinephrine
Hypoadrenalism
Insulin
Adrenal gland hypofunction

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Pathologic Processes
Disease

Therapeutic Uses
Syndrome
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009