Insulin Sensitivity and Substrate Metabolism in Patients With Cushing's Syndrome

This study is currently recruiting participants.

Verified by University of Aarhus, December 2008

Sponsors and Collaborators:	University of Aarhus Aarhus University Hospital
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00682084

Purpose

The purpose of this study is to investigate the effect og chronic elevated levels of cortisol on metabolism and insulin sensitivity.

Condition	Intervention
Cushing's Syndrome Insulin Resistance	Procedure: Surgery

MedlinePlus related topics: Cushing's Syndrome

Drug Information available for: Insulin Dextrose Epinephrine Epinephrine bitartrate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Insulin Sensitivity and Substrate Metabolism in Patients With Cushing's Syndrome Before and After Surgical Treatment

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

Insulin sensitivity [ Time Frame: Before and after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Glucose tolerance, QoL, body composition, intrahepatic and intramyocellular fat, substrate metabolism. [ Time Frame: Before and after treatment ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Whole blood, serum, muscle samples, fat samples

Estimated Enrollment:	10
Study Start Date:	April 2008
Estimated Study Completion Date:	January 2016
Estimated Primary Completion Date:	July 2015 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Patients recently diagnosed with Cushing's syndrome	Procedure: Surgery Surgical removal of either a pituitary or ectopic ACTH producing tumor or an adrenal tumor

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients recently diagnosed with Cushing's syndrome, recruited from the clinic.

Criteria

Inclusion Criteria:

Written consent
Age between 18 and 70
Diagnosed with Cushing's syndrome

Exclusion Criteria:

Suspected malignancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682084

Contacts

Contact: Jens Otto L. Jørgensen, Professor MD	89492025 ext +45	joj@ki.au.dk
Contact: Michael Madsen, MD	89492171 ext +45	michael.madsen@ki.au.dk

Locations

Denmark, Aarhus
Department of Endocrinology	Recruiting
Aarhus C, Aarhus, Denmark, 8000
Principal Investigator: Jens Otto L. Jørgensen, Professor MD
Sub-Investigator: Michael Madsen, MD

Sponsors and Collaborators

University of Aarhus

Aarhus University Hospital

Investigators

Principal Investigator:

Jens Otto L. Jørgensen, Professor MD

Aarhus University Hospital, Department of Endocrinology

More Information

Responsible Party:	Aarhus University Hospital ( Jens Otto Lunde Jørgensen )
Study ID Numbers:	MM-ISC-20070131
Study First Received:	May 20, 2008
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00682084
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics; Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:

Cushing's syndrome
Glucose tolerance
Insulin sensitivity
Substrate metabolism
Body composition

Study placed in the following topic categories:

Hyperinsulinism
Metabolic Diseases
Cushing Syndrome
Endocrine System Diseases
Adrenal Gland Diseases
Endocrinopathy

Insulin Resistance
Epinephrine
Metabolic disorder
Glucose Metabolism Disorders
Adrenocortical Hyperfunction
Insulin

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009