NCT00699530

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

May 1, 2008

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2008

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 18, 2008

Completed
8.4 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

8.5 years

First QC Date

May 23, 2008

Last Update Submit

December 21, 2017

Conditions

HyperprolactinemiaInsulin Resistance

Keywords

ProlactinInsulin resistanceGlucose toleranceBody CompositionSubstrate metabolism

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    Before and after treatment

Secondary Outcomes (1)

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

    Before and after treatment

Study Arms (1)

Hyperprolactinemia

Patients recently diagnosed with hyperprolactinemia

Other: Cabergoline

Interventions

CabergolineOTHER

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

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 hyperprolactinemia

You may qualify if:

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

You may not qualify if:

  • Hypothyroidism
  • Use of any medication
  • Pregnancy

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

HyperprolactinemiaInsulin Resistance

Interventions

Cabergoline

Condition Hierarchy (Ancestors)

HyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ErgolinesErgot AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-Ring

Study Officials

  • Jens Otto L. Jørgensen, Professor MD

    Aarhus University Hospital, Department of Endocrinology

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

May 23, 2008

First Posted

June 18, 2008

Study Start

May 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)