Insulin Sensitivity and Substrate Metabolism in Patients... | NCT00682084

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

NCT00682084

Sponsor

University of Aarhus

Status

Terminated

Last Update Posted

Dec 22, 2017Actual

Enrollment

1Actual

Phase

Not provided

Conditions

Cushing's Syndrome
Insulin Resistance

Interventions

Surgery

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment problems

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Nov 2016Actual

Completion Date

Nov 2016Actual

First Submitted Date

May 20, 2008

First Submission Date that Met QC Criteria

May 20, 2008

First Posted Date

May 22, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2017

Last Update Posted Date

Dec 22, 2017Actual

Name	Class
Aarhus University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Patients recently diagnosed with Cushing's syndrome	Procedure: Surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgery	Procedure	Surgical removal of either a pituitary or ectopic ACTH producing tumor or an adrenal tumor	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Insulin sensitivity		Before and after treatment

Secondary Outcomes

Measure	Description	Time Frame
Glucose tolerance, QoL, body composition, intrahepatic and intramyocellular fat, substrate metabolism.		Before and after treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Suspected malignancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jens Otto L. Jørgensen, Professor MD	Aarhus University Hospital, Department of Endocrinology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Endocrinology		Aarhus C	Aarhus	8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D003480	Cushing Syndrome
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D000308	Adrenocortical Hyperfunction
D000307	Adrenal Gland Diseases
D004700	Endocrine System Diseases
D006946	Hyperinsulinism

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided