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

This study is currently recruiting participants.

Verified by University of Aarhus, October 2009

First Received: May 20, 2008 Last Updated: October 21, 2009 History of Changes

Sponsor:	University of Aarhus
Collaborator:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Cushing's Syndrome Surgery

Drug Information available for: Insulin

U.S. FDA Resources

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

No publications provided

Responsible Party:	Aarhus University Hospital ( Jens Otto Lunde Jørgensen )
Study ID Numbers:	MM-ISC-20070131
Study First Received:	May 20, 2008
Last Updated:	October 21, 2009
ClinicalTrials.gov Identifier:	NCT00682084 History of Changes
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

Additional relevant MeSH terms:

Metabolic Diseases
Disease
Physiological Effects of Drugs
Cushing Syndrome
Adrenal Gland Diseases
Endocrine System Diseases
Adrenocortical Hyperfunction
Pharmacologic Actions

Insulin
Hyperinsulinism
Pathologic Processes
Hypoglycemic Agents
Syndrome
Insulin Resistance
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010