Metabolic Effects of Acute Cortisol Withdrawal in Adrenal Failure

Condition(s) targeted: Addison Syndrome

Intervention: hydrocortisone substitution therapy versus withdrawal (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Aarhus

Official(s) and/or principal investigator(s):
Jens Juel Christiansen, PhD, Principal Investigator, Affiliation: University of Aarhus
Claus H Gravholt, MD, Study Chair, Affiliation: University of Aarhus
Christian B Djurhuus, PhD, Study Chair, Affiliation: University of Aarhus
Per Iversen, PhD, Study Chair, Affiliation: University of Aarhus
Jens S Christiansen, Professor, Study Chair, Affiliation: University of Aarhus
Ole Schmidt, Professor, Study Chair, Affiliation: University of Aarhus
Jørgen Weeke, Professor, Study Chair, Affiliation: University of Aarhus
Jens OL Jørgensen, MD, Study Chair, Affiliation: University of Aarhus
Niels Møller, Professor, Study Director, Affiliation: University of Aarhus

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.

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

Study design: Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment, Bio-equivalence Study

Primary outcome:

insulin sensitivity

local protein turnover

whole body protein turnover

glucose metabolism

serum metabolites

serum hormone levels

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Female adrenal failure

- Age 18-50

- Written informed content

Exclusion Criteria:

- Diabetes mellitus

- Cancer

- Thromboembolic events

- Pregnancy and lactation

- Heart disease

Starting date: January 2002
Ending date: January 2003
Last updated: February 28, 2007