Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University of Aarhus
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00699530
First received: May 23, 2008
Last updated: December 2, 2014
Last verified: December 2014

May 23, 2008
December 2, 2014
May 2008
June 2015   (final data collection date for primary outcome measure)
Insulin sensitivity [ Time Frame: Before and after treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00699530 on ClinicalTrials.gov Archive Site
QoL, body composition, intrahepatic and intramyocellular fat, substrate metabolism, glucose tolerance [ Time Frame: Before and after treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Substrate Metabolism and Insulin Sensitivity in Patients With Hyperprolactinemia Before and After Treatment
Substrate Metabolism and Insulin Sensitivity in Patients With Hyperprolactinemia Before and After Treatment
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Whole blood, serum, muscle samples, fat samples
Non-Probability Sample
Patients recently diagnosed with hyperprolactinemia
  • Hyperprolactinemia
  • Insulin Resistance
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.
Hyperprolactinemia
Patients recently diagnosed with hyperprolactinemia
Intervention: Other: Cabergoline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
January 2016
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years   (Adult, Senior)
No
Contact: Jens Otto L. Jørgensen, Professor MD 89-49-2025 ext +45 joj@ki.au.dk
Contact: Michael Madsen, MD 89-49-2171 ext +45 michael.madsen@ki.au.dk
Denmark
 
NCT00699530
MM-ISP-20070132
No
Not Provided
Not Provided
University of Aarhus
University of Aarhus
Aarhus University Hospital
Principal Investigator: Jens Otto L. Jørgensen, Professor MD Aarhus University Hospital, Department of Endocrinology
University of Aarhus
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP