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WithdrawnNCT00699530Updated Dec 22, 2017

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

An observational study in Hyperprolactinemia and Insulin Resistance, sponsored by University of Aarhus. Withdrawn at 1 site in Denmark. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-12-22.

Sponsored by University of Aarhus · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hyperprolactinemia
  • Insulin Resistance

Keywords

  • Prolactin
  • Insulin resistance
  • Glucose tolerance
  • Body Composition
  • Substrate metabolism
03

In context

Hyperprolactinemia

39 studies on the registry are indexed under Hyperprolactinemia; 4 are open to participants now.

Browse Hyperprolactinemia studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.

Browse University of Aarhus studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients recently diagnosed with hyperprolactinemia

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Hypothyroidism
  • Use of any medication
  • Pregnancy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • Hyperprolactinemia

    Patients recently diagnosed with hyperprolactinemia

    Other: Cabergoline

Interventions

  • OtherCabergoline

    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.

06

What researchers measure

Primary outcomes

  1. Insulin sensitivity

    Time frame: Before and after treatment

Secondary outcomes

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

    Time frame: Before and after treatment

07

Study locations

1 site
  • Department of Endocrinology
    Aarhus C, Aarhus 8000, Denmark
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2008, a primary completion of Nov 2016 and a completion of Nov 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 23, 2008
First posted
Jun 18, 2008
Start
May 2008
Primary completionActual
Nov 2016
CompletionActual
Nov 2016
Last update
Dec 22, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 22, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00699530
Lead sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
Responsible party
Sponsor
First posted
Jun 18, 2008
Start date
May 2008
Primary completion
Nov 2016
Completion
Nov 2016
Last update
Dec 22, 2017

Study contacts

Jens Otto L. Jørgensen, Professor MD
principal investigator · Aarhus University Hospital, Department of Endocrinology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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