Text Size

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

This study is currently recruiting participants.
Verified November 2012 by University of Aarhus
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00682084
First received: May 20, 2008
Last updated: November 6, 2012
Last verified: November 2012
History of Changes
  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:

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

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
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: University of Aarhus
ClinicalTrials.gov Identifier: NCT00682084     History of Changes
Other Study ID Numbers: MM-ISC-20070131
Study First Received: May 20, 2008
Last Updated: November 6, 2012
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:
Cushing Syndrome
Insulin Resistance
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Hyperinsulinism
 Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013