Metabolic Effects of Acute Cortisol Withdrawal in Adrenal Failure

• Sponsor: University of Aarhus (Other)
• Overall Status: Completed
• CT.gov ID: NCT00442390
• Collaborator: (none)
• Enrollment: 10
• Duration (Months): 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Addison Syndrome	Drug: hydrocortisone substitution therapy versus withdrawal	N/A

Study Design

• Study Type: Interventional
• 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.
• Study Start Date: Jan 1, 2002
• Study Completion Date: Jan 1, 2003

Outcome Measures

Primary Outcome Measures

1. insulin sensitivity []

2. local protein turnover []

3. whole body protein turnover []

4. glucose metabolism []

5. serum metabolites []

6. serum hormone levels []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00442390
• Other Study ID Numbers: 1998/4375
• First Posted: Mar 1, 2007
• Last Update Posted: Mar 1, 2007
• Last Verified: Feb 1, 2007

• Keywords provided by , ,: Cortisol; adrenal insufficiency; glucose metabolism; protein metabolism; lipid metabolism; insulin sensitivity.
• Additional relevant MeSH terms: Hydrocortisone

Study Results

No Results Posted as of Mar 1, 2007