Metabolic Effects of Acute Cortisol Withdrawal in Adrenal Failure

February 28, 2007 updated by: University of Aarhus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

10

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female adrenal failure
  • Age 18-50
  • Written informed content

Exclusion Criteria:

  • Diabetes mellitus
  • Cancer
  • Thromboembolic events
  • Pregnancy and lactation
  • Heart disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Study Completion

January 1, 2003

Study Registration Dates

First Submitted

February 28, 2007

First Submitted That Met QC Criteria

February 28, 2007

First Posted (Estimate)

March 1, 2007

Study Record Updates

Last Update Posted (Estimate)

March 1, 2007

Last Update Submitted That Met QC Criteria

February 28, 2007

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1998/4375

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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