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

December 21, 2017 updated by: University of Aarhus
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Aarhus
      • Aarhus C, Aarhus, Denmark, 8000
        • Department of Endocrinology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients recently diagnosed with hyperprolactinemia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hyperprolactinemia
Patients recently diagnosed with hyperprolactinemia
Other: Cabergoline
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Insulin sensitivity
Time Frame: Before and after treatment
Before and after treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (ACTUAL)

November 1, 2016

Study Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

May 23, 2008

First Submitted That Met QC Criteria

June 13, 2008

First Posted (ESTIMATE)

June 18, 2008

Study Record Updates

Last Update Posted (ACTUAL)

December 22, 2017

Last Update Submitted That Met QC Criteria

December 21, 2017

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MM-ISP-20070132

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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