Substrate Metabolism and Insulin Sensitivity in Patients... | NCT00699530

Studies
Substrate Metabolism and Insulin Sensitivity in Patients With Hyperprolactinemia Before and After Treatment

NCT00699530

Sponsor

University of Aarhus

Status

Withdrawn

Last Update Posted

Dec 22, 2017Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Hyperprolactinemia
Insulin Resistance

Interventions

Cabergoline

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

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Nov 2016Actual

Completion Date

Nov 2016Actual

First Submitted Date

May 23, 2008

First Submission Date that Met QC Criteria

Jun 13, 2008

First Posted Date

Jun 18, 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 effects of chronic elevated levels of Prolactin on metabolism and insulin sensitivity by studying patients with hyperprolactinemia before and after treatment.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hyperprolactinemia		Patients recently diagnosed with hyperprolactinemia	Other: Cabergoline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cabergoline	Other	Cabergoline 0,25 - 1,0 mg once a week, controlled by our outpatient clinic. The drug regimen is not influenced by participating in this study.	Hyperprolactinemia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Insulin sensitivity		Before and after treatment

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written consent
Age between 18 and 70
At diagnose a serum prolactin > 200 microgram/l (10 U/l)

Exclusion Criteria:

Hypothyroidism
Use of any medication
Pregnancy

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 hyperprolactinemia

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
D006966	Hyperprolactinemia
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D006964	Hyperpituitarism
D010900	Pituitary Diseases
D007027	Hypothalamic Diseases
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077465	Cabergoline

Ancestor Terms

ID	Term
D004873	Ergolines
D004876	Ergot Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided