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

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ClinicalTrials.gov Identifier: NCT00682084
Recruitment Status : Terminated (Recruitment problems)
First Posted : May 22, 2008
Last Update Posted : December 22, 2017
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to investigate the effect og chronic elevated levels of cortisol on metabolism and insulin sensitivity.

Condition or disease Intervention/treatment
Cushing's Syndrome Insulin Resistance Procedure: Surgery

Study Design
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Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Insulin Sensitivity and Substrate Metabolism in Patients With Cushing's Syndrome Before and After Surgical Treatment
Study Start Date : April 2008
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Secondary Outcome Measures :
  1. 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

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Locations
Denmark
Department of Endocrinology
Aarhus C, Aarhus, Denmark, 8000
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00682084     History of Changes
Other Study ID Numbers: MM-ISC-20070131
First Posted: May 22, 2008    Key Record Dates
Last Update Posted: December 22, 2017
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