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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University of Aarhus.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00682084
First Posted: May 22, 2008
Last Update Posted: December 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
  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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Insulin Sensitivity and Substrate Metabolism in Patients With Cushing's Syndrome Before and After Surgical Treatment

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: Before and after treatment ]

Secondary Outcome Measures:
  • Glucose tolerance, QoL, body composition, intrahepatic and intramyocellular fat, substrate metabolism. [ Time Frame: Before and after treatment ]

Biospecimen Retention:   Samples Without DNA
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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: University of Aarhus
ClinicalTrials.gov Identifier: NCT00682084     History of Changes
Other Study ID Numbers: MM-ISC-20070131
First Submitted: May 20, 2008
First Posted: May 22, 2008
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by University of Aarhus:
Cushing's syndrome
Glucose tolerance
Insulin sensitivity
Substrate metabolism
Body composition

Additional relevant MeSH terms:
Syndrome
Hypersensitivity
Insulin Resistance
Cushing Syndrome
Disease
Pathologic Processes
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs