NCT00682084

Brief Summary

The purpose of this study is to investigate the effect og chronic elevated levels of cortisol on metabolism and insulin sensitivity.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2008

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 22, 2017

Status Verified

December 1, 2014

Enrollment Period

8.6 years

First QC Date

May 20, 2008

Last Update Submit

December 21, 2017

Conditions

Cushing's SyndromeInsulin Resistance

Keywords

Cushing's syndromeGlucose toleranceInsulin sensitivitySubstrate metabolismBody composition

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    Before and after treatment

Secondary Outcomes (1)

  • Glucose tolerance, QoL, body composition, intrahepatic and intramyocellular fat, substrate metabolism.

    Before and after treatment

Study Arms (1)

1

Patients recently diagnosed with Cushing's syndrome

Procedure: Surgery

Interventions

SurgeryPROCEDURE

Surgical removal of either a pituitary or ectopic ACTH producing tumor or an adrenal tumor

1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients recently diagnosed with Cushing's syndrome, recruited from the clinic.

You may qualify if:

  • Written consent
  • Age between 18 and 70
  • Diagnosed with Cushing's syndrome

You may not qualify if:

  • Suspected malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology

Aarhus C, Aarhus, 8000, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, serum, muscle samples, fat samples

MeSH Terms

Conditions

Cushing SyndromeInsulin Resistance

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jens Otto L. Jørgensen, Professor MD

    Aarhus University Hospital, Department of Endocrinology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2008

First Posted

May 22, 2008

Study Start

April 1, 2008

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

December 22, 2017

Record last verified: 2014-12

Locations

DK(1)