Insulin Sensitivity and Substrate Metabolism in Patients With Cushing's Syndrome
This study is currently recruiting participants.
(see Contacts and Locations)
Verified December 2014 by University of Aarhus
Sponsor:
University of Aarhus
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00682084
First received: May 20, 2008
Last updated: December 2, 2014
Last verified: December 2014
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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:
Genetics Home Reference related topics:
Cushing disease
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00682084
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: | December 2, 2014 |
| 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:
|
Insulin Resistance Cushing Syndrome Syndrome Adrenal Gland Diseases Adrenocortical Hyperfunction Disease |
Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on March 01, 2015